This is audit pack provides structured, risk‑based interview checklists covering Raw Material QC, Finished Product QC, Microbiology, and Packaging Materials in a pharmaceutical facility. Each section breaks requirements into practical questions with drill‑down subpoints to verify compliance, traceability, and real on‑floor practices. It emphasizes high‑risk areas such as sampling integrity, CoA reliance, method/version control, OOS/OOT investigations, chromatography data integrity, sterility/LAL controls, EM trending, and printed artwork/line clearance. The checklists are designed to uncover hidden loopholes like testing into compliance, mix‑ups, inadequate segregation (especially for potent women hormones), and weak reconciliation/release controls.
RAW MATERIAL QC (50 Points)
1) How is the ASL (Approved Supplier List) controlled for raw materials?
1.1 Show the latest ASL (document no., revision, effective date).
1.2 Is the ASL risk-based (API vs excipients vs critical materials)?
1.3 What is the approval workflow to add a supplier (QA approval + risk assessment)?
1.4 How is supplier disqualification communicated and implemented (ERP block, memo, training)?
2) How do you perform supplier qualification?
2.1 Show the last supplier audit report (scope, findings, CAPA status).
2.2 If no audit, show the justification/risk assessment.
2.3 Do you qualify suppliers using trial lots with tightened testing/sampling? Evidence?
2.4 How often is supplier qualification reviewed/re-approved?
3) Do you have a Quality Agreement with suppliers and does it work?
3.1 Is change notification included (site/process/spec/raw source changes)?
3.2 Are CoA requirements, traceability, and record retention defined?
3.3 Are investigation support timelines defined (supplier response time)?
3.4 Does it include data integrity (ALCOA+) expectations?
4) If you buy via Broker/Trader, how do you ensure manufacturer traceability?
4.1 Do you require original manufacturer identification on CoA?
4.2 Do you obtain manufacturer CoA in addition to trader CoA?
4.3 If repacking occurs, is repacker qualified and approved?
4.4 Is counterfeit risk assessed for high-risk APIs?
5) How do you monitor supplier performance trending?
5.1 Show supplier-wise rejection/complaint trend (last 6–12 months).
5.2 What triggers actions (tightened testing, re-audit, CAPA request)?
5.3 Is CAPA response time tracked and escalated if late?
5.4 Is there an annual supplier performance review with QA sign-off?
6) What checks are performed at material receipt?
6.1 Do you verify quantity, container condition, and seal integrity? Evidence (GRN).
6.2 How are damaged/dirty/leaking containers handled (deviation + assessment)?
6.3 For temperature-sensitive materials, who reviews transport logger/excursions?
6.4 How do you prevent acceptance of wrong material (label mismatch workflow)?
7) How do you control Quarantine labeling?
7.1 Who issues Quarantine labels and are they controlled (issuance log)?
7.2 Does the label include material code, lot, status, date, signature?
7.3 If relabeling is needed, is there second-person verification?
7.4 Are barcode/ERP printed labels used to reduce errors?
8) How is status controlled in ERP/LIMS?
8.1 Who can change status (role-based access)? Show user roles.
8.2 Is there an audit trail for status changes? Show an example.
8.3 How do you reconcile ERP status vs physical labels routinely?
8.4 Is production prevented from issuing material before release (system block)?
9) Is physical segregation of Quarantine/Approved/Rejected effective?
9.1 Show segregated areas/cages/locks and signage.
9.2 How do you prevent mix-up of similar containers/lots?
9.3 How are rejected materials controlled until disposal/return?
9.4 Are returned materials stored separately and controlled?
10) Do you allow conditional release/urgent use of raw materials?
10.1 Is there an SOP defining when conditional release is allowed?
10.2 Is QA approval mandatory with documented risk assessment?
10.3 How do you manage post-use test completion tracking?
10.4 Show one conditional release case (last 1 year), if any.
11) How is the sampling plan defined (n√N / risk-based)?
11.1 Is sampling plan different for API vs excipients vs critical materials?
11.2 Is tightened sampling used for new suppliers/first lots?
11.3 How do you document random container selection (container list)?
11.4 What happens if sampling deviates from plan (deviation record)?
12) How do you ensure container selection is truly random?
12.1 Show sampled container numbers vs total containers received.
12.2 What method is used for randomization (random list/number)?
12.3 Does supervisor/QA perform spot checks? Evidence?
12.4 For multi-pallet lots, do you sample across pallets? Criteria?
13) When is composite sampling allowed and controlled?
13.1 Is there a list of materials allowed/not allowed for composite samples?
13.2 Is risk documented (container variability can be masked)?
13.3 Is the composite preparation method defined (equal portions, mixing)?
13.4 Are container numbers included in traceability records?
14) How is the sampling area/room controlled?
14.1 Where sampling occurs (sampling room vs warehouse) and why?
14.2 Are cleaning and line clearance documented before/after sampling?
14.3 For hygroscopic materials, how is RH exposure minimized and controlled?
14.4 Is traffic control implemented to reduce contamination risk?
15) How are sampling tools controlled?
15.1 Are tools dedicated by material family/potent category?
15.2 Show tool cleaning SOP and last cleaning records.
15.3 Are clean tools stored covered, labeled, and protected from contamination?
15.4 How do you detect/replace damaged or rusty tools?
16) How do you prevent sampling contamination?
16.1 Are glove-change rules defined (per container/per material)?
16.2 Is opening multiple containers at once prohibited/controlled?
16.3 How are spills handled (cleaning + documentation + assessment)?
16.4 Is sampling sequence risk-based (potent last, dedicated session)?
17) Potent Women Hormone raw material sampling—what special controls exist?
17.1 Is containment available (downflow booth/isolator/negative pressure)?
17.2 Is special PPE required and followed (double gloves, mask/respirator)?
17.3 Are tools/consumables dedicated and segregated for potent materials?
17.4 Is potent waste segregated and disposed with records?
18) How is sample labeling controlled to prevent mislabeling?
18.1 Does label include sample ID, material code, lot, container no., date/time, sampler?
18.2 Are labels printed from LIMS (preferred) and controlled?
18.3 How are label errors corrected (GDP rules)?
18.4 Are tamper-evident seals used for samples?
19) How is chain of custody maintained from sampling to lab?
19.1 Is there a sample receipt log (time, receiver signature)?
19.2 Is seal integrity checked and documented upon receipt?
19.3 Is sample storage location logged (cabinet/fridge ID)?
19.4 If sample is lost/broken, is deviation mandatory?
20) How is sample holding time controlled?
20.1 Is max holding time defined (sampling → analysis start)?
20.2 Are holding conditions defined (temperature/light protection)?
20.3 Is deviation raised for exceeded holding time with impact assessment?
20.4 Are LIMS reminders or controls used to prevent delays?
21) How is the retain sample program managed?
21.1 Is retain quantity sufficient for full retest + investigation?
21.2 Are retains labeled completely (lot/date/storage/location)?
21.3 Are retain storage conditions monitored with alarms and excursions handled?
21.4 Is retain access controlled and logged (removal/reconciliation)?
22) How are warehouse storage conditions controlled?
22.1 Is temp/RH monitored (continuous or daily logs) with alarm response?
22.2 Is warehouse mapping/qualification available for critical zones?
22.3 Are excursions investigated with documented impact assessment?
22.4 Is FEFO/FIFO verified physically (show one example)?
23) How are partially used containers controlled?
23.1 Is “Opened on” date recorded and status updated?
23.2 Are resealing requirements defined (liner/desiccant/tape)?
23.3 Is retest date updated and tracked in ERP/LIMS?
23.4 How do you prevent mix-up between lots of the same material?
24) How do you review incoming CoA?
24.1 Do you compare CoA tests/methods/limits/units against your specification?
24.2 Do you require numeric results (not only “Pass”)?
24.3 Do you verify mfg/retest/expiry date logic and batch identity?
24.4 How do you verify CoA authenticity (source, signature, format control)?
25) If CoA reliance/reduced testing is used, how is it justified and verified?
25.1 Is there an approved reduced-testing list with QA approval?
25.2 Is periodic full verification testing scheduled and executed?
25.3 Are CoA vs internal results trended to detect inconsistencies?
25.4 Does verification failure trigger supplier CAPA and tightened testing?
26) How is specification version control ensured?
26.1 Where are current specs stored (controlled system) and how do analysts confirm latest?
26.2 How do you prevent use of obsolete printouts/worksheets?
26.3 Are analysts trained on revised specs before use? Evidence?
26.4 Are market/registration-specific specs mapped and controlled?
27) How do you manage USP/EP/BP updates?
27.1 Who monitors pharmacopeia changes and how often?
27.2 Is impact assessment documented with closure evidence?
27.3 Are method/spec updates controlled via Change Control?
27.4 Is training completed before the change becomes effective?
28) How do you ensure analysts follow the current STP/method?
28.1 Are critical steps highlighted (time/temp/pH/sequence)?
28.2 How are method deviations documented and assessed?
28.3 If method transferred, is verification/transfer report available?
28.4 Is analyst competency/authorization documented for each method?
29) Identity testing controls (FTIR/UV/chemical)—are they robust?
29.1 Is library/version control implemented (FTIR) with approval?
29.2 Are acceptance criteria defined (match/correlation %)?
29.3 Are reference spectra traceable and controlled?
29.4 What is the workflow for ambiguous/failing ID?
30) How do you control reference standards / working standards?
30.1 Are primary standard COAs traceable and current (expiry/retest tracked)?
30.2 Are working standards qualified against primary standards with reports?
30.3 Are potency/LOD/water corrections applied consistently (example)?
30.4 Are storage conditions monitored (2–8°C/desiccator/light protection)?
31) How is standard solution preparation controlled?
31.1 Does prep record include balance ID, weights, dilutions, glassware IDs?
31.2 Are prepared-by and checked-by signatures mandatory?
31.3 Is solution expiry/hold time scientifically justified?
31.4 Is reuse of old solutions prohibited/controlled?
32) How are reagents/volumetric solutions controlled?
32.1 Are reagent labels complete (name, conc, prep date, expiry, preparer/checker)?
32.2 Is standardization factor recorded for volumetric solutions?
32.3 Is “top-up” prohibited and monitored?
32.4 Is disposal of expired reagents documented?
33) How is glassware cleaning controlled?
33.1 Is cleaning SOP defined (detergent → rinse → final rinse → dry)?
33.2 Is final rinse water grade defined (PW/DI/HPLC water)?
33.3 Is dust-free storage ensured (covered storage)?
33.4 Is dedicated glassware used for potent/hormone materials?
34) How is balance control ensured?
34.1 Are daily check weights traceable and recorded?
34.2 Do weighing logs include balance ID/time/analyst sign?
34.3 If check fails, is impact assessment performed on affected tests?
34.4 Is balance environment controlled (draft/vibration)?
35) How is pH meter control ensured?
35.1 Is daily 2/3-point calibration performed with records?
35.2 Are buffers controlled (label/expiry/storage)?
35.3 Is electrode cleaning/storage defined and followed?
35.4 What happens if calibration fails (stop test/deviation/alternate meter)?
36) HPLC qualification and maintenance—are instruments fit for use?
36.1 Show IQ/OQ/PQ status and calibration/PM schedule.
36.2 Show last PM record and breakdown log (if any).
36.3 Is column history tracked (usage, product, cleaning, storage)?
36.4 Are alarms/limits active (pressure/leak) and reviewed?
37) HPLC System Suitability (SST) governance
37.1 Are SST criteria defined (RSD, tailing, plates, resolution)?
37.2 Is there a checklist for SST failure investigation?
37.3 Are rerun/reinject rules strict and controlled (QA visibility)?
37.4 Is SST calculation independently reviewed?
38) Integration/reprocessing controls (major data integrity risk)
38.1 Is there an integration guideline (baseline/peak split/merge rules)?
38.2 Is manual integration allowed only with documented justification?
38.3 Are reprocessing permissions role-restricted?
38.4 Are deleted injections/runs justified and reviewed?
39) Electronic data integrity (ALCOA+) controls
39.1 Are unique user logins enforced (no shared accounts)?
39.2 Is audit trail enabled and reviewed (per batch/periodic)? Evidence?
39.3 Are backups/archives controlled and retrieval tested?
39.4 Is system time controlled/synchronized to prevent manipulation?
40) Excel/manual calculation control
40.1 Are Excel templates validated and version-controlled?
40.2 Are formulas locked with restricted access?
40.3 Are manual calculations independently checked and signed?
40.4 Are rounding/significant figure rules defined and applied?
41) OOT trending (within-spec drift)—is it implemented?
41.1 Which parameters are trended (assay, impurity, KF moisture)?
41.2 Who reviews trends and at what frequency (monthly/quarterly)?
41.3 What triggers OOT investigation and what evidence is kept?
41.4 Are CAPA and effectiveness checks linked to trend results?
42) Raw material OOS handling (Phase I/Phase II)
42.1 Is Phase-I (lab) checklist followed and documented?
42.2 Are retest/resample rules controlled with QA approval?
42.3 What evidence is required to conclude “analyst error”?
42.4 Is supplier notified and supplier CAPA requested when needed?
43) Deviation management (sampling/storage/testing)
43.1 Are deviation triggers clearly defined (hold time, label, excursions)?
43.2 Is overdue deviation tracking implemented?
43.3 Is impact assessment signed by QC+QA?
43.4 Is CAPA effectiveness verified (not only closure)?
44) Training/competency control (RM analysts)
44.1 Is there a training matrix per instrument/method?
44.2 Are analysts qualified before independent work (OJT records)?
44.3 Is periodic requalification performed?
44.4 Is training effectiveness reviewed using error/OOS trends?
45) Potent/hormone cleaning verification in QC
45.1 Is cleaning procedure defined and records maintained after potent work?
45.2 Are acceptance criteria defined (visual/swab limits) with rationale?
45.3 Is worst-case selection documented?
45.4 What happens if cleaning fails (re-clean + deviation + impact)?
46) Cross-contamination prevention in RM lab
46.1 Are potent and non-potent work areas segregated?
46.2 Are consumables dedicated (spatulas/boats/vials)?
46.3 Are dust/airborne controls and housekeeping effective?
46.4 Is potent waste segregated and disposed with records?
47) Raw material release workflow (QC → QA)
47.1 Is QC review checklist completed before QA disposition?
47.2 Is ERP status updated with traceable audit trail?
47.3 Is RM CoA template/version controlled?
47.4 Are deviations/OOS checked before final release?
48) Prevention of informal release (verbal/email)
48.1 Is verbal release prohibited by SOP and trained?
48.2 Is warehouse issue blocked in ERP before release? Evidence?
48.3 Are exceptions handled via deviation and QA approval?
48.4 Are warehouse staff trained on status controls?
49) Out-of-calibration (OOC) impact assessment
49.1 How is the affected time window determined?
49.2 How are affected lots/tests identified and controlled (hold/retest)?
49.3 Who approves final decisions (QA) and how is it documented?
49.4 Is preventive action taken (PM change, training)?
50) Reviewer discipline—does data review really work?
50.1 Is there a raw data package checklist (SST, calcs, audit trail)?
50.2 Does reviewer actually check chromatograms/audit trail before sign-off?
50.3 How do you prevent backdated reviews (system controls)?
50.4 Are review findings tracked to CAPA with closure evidence?
Packaging Materials (English Version)
Scope: Primary packaging (blister PVC/PVDC, Alu foil, bottles/caps/droppers, glass vials/ampoules, rubber stoppers, seals) + Secondary packaging (cartons, labels, leaflets, shippers) + Printed material / Artwork / Version control
1) How do you control the ASL (Approved Supplier List) for packaging materials?
1.1 Show the latest ASL (document no., revision, effective date).
1.2 Is ASL risk-based (Primary vs Secondary vs Sterile components)?
1.3 What is the approval workflow to add a new supplier (QA approval + risk assessment)?
1.4 How do you communicate supplier disqualification (ERP block, training, email notice)?
2) How is supplier qualification/audit done for packaging suppliers?
2.1 Show last supplier audit report (scope, findings, CAPA status).
2.2 How do you verify supplier certifications (e.g., ISO 15378/ISO 9001/GMP compliance)?
2.3 Do you perform trial lots / line trials before full approval? Evidence?
2.4 How often do you re-evaluate or re-qualify suppliers?
3) Do you have Quality Agreements with packaging suppliers, and are they implemented?
3.1 Does it include change notification (film thickness, ink, adhesive, resin grade, tooling)?
3.2 Does it define CoA/CoC requirements and traceability expectations?
3.3 Does it define complaint/OOS response timelines and investigation support?
3.4 Does it include data integrity / record retention / confidentiality for Artwork?
4) If materials come via Broker/Trader, how do you ensure manufacturer traceability?
4.1 Do you require original manufacturer identification on CoA/CoC?
4.2 Do you obtain manufacturer CoA in addition to trader CoA?
4.3 If repacking/relabeling occurs, is the repacker qualified and approved?
4.4 Do you perform counterfeit risk assessment for high-risk items?
5) How do you review and trend supplier performance?
5.1 Show supplier-wise rejection/complaint trend for last 6–12 months.
5.2 What triggers actions (audit frequency increase, tightened inspection, supplier CAPA)?
5.3 Do you track supplier CAPA response time and effectiveness?
5.4 Is there an annual supplier review with QA sign-off?
6) What checks are performed at receipt of packaging materials?
6.1 Do you check pallet/roll/carton condition (damage, moisture, tamper evidence)?
6.2 Do you verify quantity/count vs PO/GRN? Any mismatch deviation?
6.3 For moisture/temperature sensitive items (labels/leaflets/adhesives), do you review transport conditions?
6.4 If wrong material/print suspected, what is the quarantine + deviation process?
7) How do you manage Quarantine labeling for packaging materials?
7.1 Who issues Quarantine labels and how are labels controlled (issuance log)?
7.2 What must be on the label (item code, lot, status, date, sign)?
7.3 If a label is damaged or replaced, how is relabel verification done (second check)?
7.4 Do you use barcode/ERP-printed labels to reduce human error?
8) How is material status controlled in ERP/LIMS?
8.1 Who can change status (role-based access)? Show access list.
8.2 Is there an audit trail for status changes? Show one example.
8.3 Who reconciles ERP status vs physical labels, and how often?
8.4 Is there a system block preventing issue to production before release?
9) Is physical segregation of Quarantine/Approved/Rejected effective?
9.1 Show separate areas/cages/locks and signage.
9.2 How do you prevent mix-up between similar-looking printed items?
9.3 How are rejected/returned materials controlled until disposal/return?
9.4 Are returned materials stored separately from rejected materials?
10) How is the sampling plan defined for packaging materials?
10.1 Where is sampling plan defined (SOP/AQL/risk-based)?
10.2 For roll goods, how do you select sample locations (start/middle/end)?
10.3 For printed cartons/leaflets/labels, how do you ensure representative sampling?
10.4 If sampling is missed or deviated, do you raise a deviation?
11) How do you prevent mix-up/contamination during sampling?
11.1 Is sampling area line-cleared before sampling?
11.2 Do you prevent opening two different printed items simultaneously?
11.3 Are tools/gloves controlled and changed as required?
11.4 How do you control sample ID/labeling to prevent mislabeling?
12) How do you manage sample labeling and chain-of-custody?
12.1 Sample label includes item name/code, lot, roll no., date, sampler?
12.2 Is transfer store → QC documented (receipt log with time/signature)?
12.3 Are storage conditions for samples controlled (RH/light)?
12.4 Is sample holding time defined and deviations raised if exceeded?
Primary Packaging Controls (Material Quality)
13) How do you test/control Blister PVC/PVDC film?
13.1 Thickness/width/GSM checks with acceptance criteria?
13.2 Visual defects checks (gels, pinholes, fish-eyes) with defined criteria?
13.3 Sealability/formability tests (where applicable) documented?
13.4 CoA vs internal verification results trended?
14) How do you test/control Alu lidding foil?
14.1 Thickness/temper/print adhesion/heat-seal lacquer verification?
14.2 Pinholes/creases/scratches acceptance criteria defined?
14.3 Seal strength/peel tests (if applicable) performed?
14.4 Roll number traceability captured in batch records?
15) How do you control Alu-Alu cold form foil (if used)?
15.1 Formability/cracking risk checks defined?
15.2 Thickness/visual defects inspection performed and recorded?
15.3 Storage protection from moisture/damage controlled?
15.4 CoA verification program and trending?
16) How do you control plastic bottles (HDPE/LDPE/PET)?
16.1 Dimensional checks (neck finish/thread fit) performed?
16.2 Visual defects criteria (black specks, warpage, flash) applied?
16.3 Leak/drop/fit tests (if applicable) performed?
16.4 Compliance documents (resin grade/pharma suitability) maintained?
17) How do you control caps/closures?
17.1 Torque/fit compatibility checks defined and executed?
17.2 Liner type/compatibility verified?
17.3 Tamper-evident/child-resistant functional checks (if applicable)?
17.4 Mix-up prevention for similar colors/sizes (visual control)?
18) For Eye Drops: how do you control droppers/nozzles?
18.1 Orifice size/drop rate requirement defined and tested?
18.2 Assembly/fit trial with bottle/closure documented?
18.3 Visual cleanliness/particulate checks defined?
18.4 Material compatibility documentation maintained?
19) For sterile products: how do you control glass vials/ampoules?
19.1 Dimensional checks (neck, height, brimful capacity) performed?
19.2 Cosmetic defect criteria (cracks, bubbles, stones) used?
19.3 Glass type/hydrolytic resistance documentation verified (Type I where required)?
19.4 Traceability and storage protection to prevent breakage/contamination?
20) For sterile injections: how do you control rubber stoppers?
20.1 CoA/lot traceability includes formulation/compound lot?
20.2 Visual defects/particulate/blemish criteria defined and used?
20.3 Washed/siliconized/sterilized status verified (RTU vs non-RTU)?
20.4 Storage conditions (temp/RH) controlled and documented?
21) How do you control aluminium seals / flip-off caps?
21.1 Dimensional/fit verification on vial finish?
21.2 Risk of lacquer/paint flaking assessed?
21.3 Functional crimp trial (if applicable) performed?
21.4 Color/print mix-up prevention controls?
Printed Materials (Highest Mix-up Risk)
22) How do you control Artwork (master data)?
22.1 Where is the master Artwork stored (controlled system/access control)?
22.2 How do you ensure correct version/revision (current vs obsolete)?
22.3 Who verifies regulatory text/strength/warnings (QA/RA approval)?
22.4 Show Artwork approval workflow and final approved master.
23) Incoming control for printed labels?
23.1 Verify correct text, strength, batch/expiry fields, layout—checklist used?
23.2 Barcode/2D code readability verification performed?
23.3 Adhesive performance checks (peel) done where required?
23.4 Label roll direction/winding/orientation verified?
24) Incoming control for cartons?
24.1 Print quality, color, legibility, cut/crease alignment verified?
24.2 Carton dimensions and folding trial performed?
24.3 Security features (hologram/tamper seal) verified if applicable?
24.4 Coding area (batch/expiry) correct and readable?
25) Incoming control for leaflets/inserts?
25.1 Confirm correct text version (latest PI/SmPC) against approved Artwork?
25.2 Pagination/order verified (page sequence correct)?
25.3 Paper GSM/size/fold orientation verified?
25.4 Smudging/ink transfer criteria checked?
26) How do you perform text reconciliation against approved Artwork?
26.1 Is it line-by-line proofing or sample-based? SOP requirement?
26.2 Do you use a “golden sample”/approved reference for comparison?
26.3 What is the workflow if mismatch found (quarantine + deviation + supplier notification)?
26.4 Do you check for unintended changes vs previous lot?
27) How do you control obsolete printed materials?
27.1 Obsolete labels/cartons/leaflets stored in locked segregated area?
27.2 Obsolete destruction record with witness?
27.3 ERP block to prevent issue of obsolete item codes?
27.4 Line clearance checklist includes “obsolete search” step?
Storage, Handling, Issuance & Reconciliation
28) Packaging material storage conditions (Temp/RH) control?
28.1 Continuous or daily monitoring with alarms?
28.2 Humidity-sensitive items (leaflets/labels) in controlled conditions?
28.3 Excursion handling with impact assessment?
28.4 FEFO/FIFO practiced—show a physical example.
29) Handling control for roll goods (foil/film/labels)?
29.1 Protection against edge damage (stands/pallets/wrapping)?
29.2 Roll ID label intact and readable throughout storage/use?
29.3 Partial roll return—status relabeling and quarantine controls?
29.4 Dust protection (covered storage) and housekeeping?
30) Packaging material status labels (Approved/Rejected) governance?
30.1 Who issues labels and where recorded?
30.2 If label missing, is material automatically put on hold?
30.3 Approved label applied only after QA release—verified?
30.4 Rejected label triggers physical lock and segregation?
31) Material issuance to packaging line control?
31.1 Issue only after QA/QC release confirmation?
31.2 Dual check/barcode scanning to prevent wrong issue?
31.3 Issued quantity checked vs BOM/requirement?
31.4 Wrong-issue near-miss reporting exists?
32) On-line print verification (in-process checks) control?
32.1 Start-up “first-off approval” performed and signed?
32.2 Batch coding (batch no., mfg/exp) accuracy verified and recorded?
32.3 Vision system/barcode verifier challenge test performed?
32.4 In-process check frequency defined and followed?
33) Line clearance between batches—effectiveness?
33.1 Line clearance checklist covers all printed items and components?
33.2 QA verification and sign-off before start?
33.3 Checks include under machines/bins/surrounding areas?
33.4 Clearance failure triggers deviation?
34) Packaging reconciliation (issued vs used vs returned vs destroyed)?
34.1 Reconciliation performed for each batch with defined method?
34.2 Printed materials counted piece-by-piece vs estimate—SOP requirement?
34.3 Discrepancy triggers deviation investigation and CAPA?
34.4 QA reviews and approves reconciliation records?
35) Control of returned packaging materials (open/part-used)?
35.1 Returned materials labeled “Opened/Part-used” with date and status?
35.2 Returned quantities verified and recorded?
35.3 Segregated storage for returned items?
35.4 Reuse criteria (time/condition) clearly defined?
36) Control of scrap/waste destruction (printed items security risk)
36.1 Printed scrap is shredded/defaced before disposal?
36.2 Destruction record includes item, qty, date, witness?
36.3 Security controls prevent scrap leaving uncontrolled?
36.4 If outsourced destruction, is vendor qualified?
Sterile Packaging Component Special Controls
37) Sterile components cleanliness/pack integrity control?
37.1 Incoming cleanliness/visible particles criteria defined?
37.2 RTU vs non-RTU status clearly verified?
37.3 Sterile wrap integrity checks (tear/wet/puncture) performed?
37.4 Storage in controlled segregated area?
38) Supplier sterilization/irradiation documentation control (if applicable)
38.1 Gamma/ETO certificate reviewed and accepted?
38.2 Certificate lot matches your received lot (traceability)?
38.3 Requirements like SAL addressed (where applicable)?
38.4 Certificate authenticity verification practice?
39) CCIT awareness—packaging component changes impact?
39.1 Stopper/vial/seal change triggers CCIT impact assessment?
39.2 Supplier/lot change risk assessment exists?
39.3 Complaint trending (leakers) by component lot?
39.4 Sterile failure investigations consider packaging component linkage?
Change Control / Deviations / Complaints / People
40) Packaging specification control (dimensions/print requirements)
40.1 Spec master list + version control exists?
40.2 Spec changes via Change Control with QA approval?
40.3 “Golden sample”/reference retains maintained?
40.4 Obsolete spec usage prevention?
41) Supplier change control for packaging materials
41.1 Supplier change notifications are captured in Change Control?
41.2 Impact assessment includes seal/stability/leachables risks (as applicable)?
41.3 Line trial evidence recorded before implementation?
41.4 QA approval gate before use?
42) Deviation management for packaging issues
42.1 Deviations opened for print mismatch, damage, shortage, reconciliation mismatch?
42.2 Root cause analysis covers supplier vs handling vs line causes?
42.3 CAPA tracking to closure?
42.4 Effectiveness check to ensure recurrence reduced?
43) Complaint/market feedback linkage to packaging lots
43.1 Complaint trends for label peeling/smudging/wrong leaflet tracked?
43.2 Packaging lot traceability to batch ensured?
43.3 Retain packaging samples kept for investigation?
43.4 Supplier notification and CAPA integration?
44) GDP compliance of packaging QC records
44.1 Controlled forms with issuance/reconciliation?
44.2 Corrections follow GDP (single-line strike, sign/date/reason)?
44.3 Blank spaces controlled (NA/strike-through)?
44.4 No uncontrolled loose papers?
45) Printed materials issuance/return/destruction registers
45.1 Issuance/return/destruction entries are contemporaneous?
45.2 Dual witness where required is followed?
45.3 Periodic review by supervisor/QA?
45.4 Records are retrievable and complete?
46) ERP/BOM control for packaging components
46.1 BOM links correct component codes (no alternates without control)?
46.2 System controls prevent wrong pick (scan/validation)?
46.3 Substitution requires QA approval and documentation?
46.4 ERP audit trail is reviewed for changes?
47) Training & competency (packaging QC/warehouse/line)
47.1 Training matrix covers Artwork, line clearance, reconciliation?
47.2 New personnel qualification before independent work?
47.3 Refresher training schedule exists?
47.4 Near-miss lessons lead to training updates?
48) Women Hormone (potent) packaging segregation & controls
48.1 Hormone packaging materials segregated in storage and issuance?
48.2 Visual controls/color coding to prevent mix-up?
48.3 Enhanced line clearance for hormone products evidence?
48.4 Rules on reuse/return of hormone printed materials defined?
49) Potent/hormone packaging waste handling
49.1 Hormone packaging scrap destroyed with segregation controls?
49.2 Disposal records with witness and traceability?
49.3 Security controls prevent scrap leaving uncontrolled?
49.4 EHS requirements followed and documented?
50) Final packaging material release decision control
50.1 QC release checklist covers spec + CoA/CoC + inspection results?
50.2 QA disposition gate exists (no release without QA approval)?
50.3 Informal release (verbal/email) prevented by procedure/system?
50.4 Traceability: packaging lot → finished batch mapping is available and retrievable?
FINISHED PRODUCT QC (50 Points)
1) Is the finished product sampling plan defined and followed?
1.1 Show SOP for tablet/capsule sampling (start/middle/end at compression/packing).
1.2 For sterile batches, show filling start/middle/end sampling + intervention sampling.
1.3 Who samples (QC/production) and what oversight exists?
1.4 If sampling is missed/late, is deviation raised?
2) Is sampling representative in practice?
2.1 Do you sample across shippers/cartons/positions (evidence in record)?
2.2 Do you sample across bins/drums for bulk?
2.3 Are shift changes/line speed changes considered?
2.4 Do records show convenience sampling patterns?
3) Are samples labeled correctly to prevent mix-ups?
3.1 Label includes product, strength, batch, stage, time, sampler ID?
3.2 Printed labels from LIMS used? If handwritten, verification step?
3.3 GDP corrections applied correctly on label/record?
3.4 Tamper-evident seals used where required?
4) Is chain of custody maintained?
4.1 Sample receipt log includes time/receiver signature?
4.2 Seal integrity checked on receipt and documented?
4.3 Sample storage location recorded (rack/fridge)?
4.4 Lost/broken sample triggers deviation?
5) Are samples segregated in the lab (multiple batches)?
5.1 Separate trays/racks/areas used for different batches/products?
5.2 “Unattended samples” prevented by SOP?
5.3 Retest samples uniquely identified and controlled?
5.4 LIMS login is timely (no back-entry)?
6) Is the correct specification (current version) always used?
6.1 LIMS auto-selects specs by product code/strength? Show mapping.
6.2 Obsolete spec/worksheet use prevented?
6.3 Market/registration specs controlled and mapped?
6.4 Analysts trained on spec revisions with evidence?
7) Are all required release tests performed?
7.1 Release vs periodic test matrix exists and is followed?
7.2 Missing tests block release/CoA in system?
7.3 Skip testing rules require QA approval + justification?
7.4 Out-of-schedule testing tracked and investigated?
8) Is method validation/verification linked to current formulation/process?
8.1 Validation report matches current strength/matrix?
8.2 Change control triggers revalidation where needed?
8.3 Compendial method verification exists?
8.4 Robustness and critical parameters are defined?
9) Is method revision control effective at the bench?
9.1 Controlled STP access; analysts confirm latest revision?
9.2 Critical steps are clearly highlighted (time/temp/pH)?
9.3 Method deviations handled via deviation system?
9.4 Training completed before method effective date?
HPLC/GC (High risk)
10) Are HPLC systems qualified and maintained?
10.1 IQ/OQ/PQ, calibration, PM current?
10.2 Breakdown deviation + impact assessment exists?
10.3 Column history maintained?
10.4 Alarm/limits functional (pressure/leak)?
11) Is HPLC sequence setup controlled?
11.1 Sequence includes blank, SST, standards, bracketing, samples?
11.2 Carryover checks included (blank after high standard)?
11.3 Sequence templates locked/controlled?
11.4 Peer review of sequence setup documented?
12) Are SST criteria defined and failures handled correctly?
12.1 SST criteria documented (RSD, tailing, plates, resolution)?
12.2 SST failure checklist used before rerun?
12.3 Rerun/reinject rules strict and controlled?
12.4 SST calculations independently reviewed?
13) Is standard preparation controlled (HPLC/GC)?
13.1 Potency correction applied with documented calculations?
13.2 Prepared-by and checked-by signatures present?
13.3 Standard solution expiry/hold time defined and followed?
13.4 Storage conditions maintained and recorded?
14) Is sample preparation controlled (HPLC/impurities)?
14.1 Weighing traceability (balance ID/log) maintained?
14.2 Extraction/sonication time and conditions controlled?
14.3 Filter compatibility/adsorption evidence exists?
14.4 Sample solution stability/reinject window defined?
15) Is integration/reprocessing controlled? (common loophole)
15.1 Integration guideline exists (baseline/peak split/merge)?
15.2 Manual integration requires documented justification?
15.3 Audit trail captures changes and reviewer signs?
15.4 Selective integration only to “make pass” is monitored and prevented?
16) Chromatography data integrity controls
16.1 Unique user logins (no shared accounts)?
16.2 Audit trail enabled and reviewed per batch/periodic?
16.3 Deleted injections/runs justified and reviewed?
16.4 Backup/archival and retrieval testing exists?
17) Calculation/transcription controls
17.1 Instrument→LIMS interface validated (if used)?
17.2 Manual entry double-checked and documented?
17.3 Rounding/unit conversion rules defined and followed?
17.4 CoA vs LIMS reconciliation step exists?
Dissolution (Tablet/Capsule)
18) Is dissolution apparatus qualified and verified?
18.1 Mechanical checks (RPM/temp/centering/wobble) current?
18.2 Vessel verification/PVT performed if required?
18.3 Cleaning logs and carryover prevention present?
18.4 Timer accuracy verified periodically?
19) Is dissolution media preparation controlled?
19.1 Media pH adjustment/verification recorded?
19.2 Degassing method standardized and followed?
19.3 Media temperature at start controlled and recorded?
19.4 Media hold time defined and followed?
20) Is dissolution sampling/timing controlled?
20.1 Sampling time accuracy maintained; delays recorded?
20.2 Volume replacement/correction rules followed?
20.3 Filter compatibility evidence exists?
20.4 S1/S2/S3 stage rules correctly applied?
21) Dissolution failures—investigation discipline
21.1 Single vessel failure handled per SOP (not immediate rerun)?
21.2 Mechanical checks reviewed during investigation?
21.3 Retest rules controlled with approvals?
21.4 OOT trending used to detect gradual drift?
KF / GC / Physical tests
22) KF controls (instrument + reagents)
22.1 Drift/blank limits defined and monitored?
22.2 Reagent factorization schedule followed?
22.3 Moisture pickup prevented during sample handling?
22.4 High drift triggers investigation/actions?
23) KF calculation and verification
23.1 Template validated (LIMS/controlled Excel)?
23.2 Duplicate determination rules defined?
23.3 Reviewer sign-off on results?
23.4 Moisture OOT trending performed?
24) GC residual solvents controls (if applicable)
24.1 SST/curve criteria defined and met?
24.2 Headspace vial crimp/leak controls in place?
24.3 Reinjection policy controlled with justification/approval?
24.4 Parameter changes controlled via change control?
25) Tablet/Capsule physical tests control
25.1 Equipment calibration/verification current?
25.2 Sample selection and sample size representative?
25.3 Retest rules controlled and documented?
25.4 GDP recording and independent review performed?
26) Content Uniformity (CU) governance
26.1 CU sampling rules and method are current?
26.2 Calculation template validated and formulas locked?
26.3 Rounding rules defined and followed?
26.4 Acceptance stage rules correctly applied with second review?
Sterile product related QC interfaces
27) Eye drops appearance/clarity/visible particles control
27.1 Light box qualification and maintenance records current?
27.2 Acceptance criteria clearly defined (objective guidance)?
27.3 Operator training/qualification documented?
27.4 Retest/recheck rules controlled?
28) Eye drops pH/osmolality/viscosity controls
28.1 Instrument calibration/verification current?
28.2 Standards/buffers expiry controlled?
28.3 Sample temperature equilibration rules defined?
28.4 Cleaning between samples prevents carryover?
29) Injections particulate/clarity testing (if applicable)
29.1 Instrument qualification and method control?
29.2 Sample handling SOP followed?
29.3 Failure triggers investigation (not only retest)?
29.4 Trending by line/shift performed?
30) Sterile batch release gating (Sterility/LAL completion)
30.1 QA disposition requires sterility and LAL completion?
30.2 ERP/LIMS gate blocks release if micro pending?
30.3 Conditional release criteria controlled by SOP?
30.4 Missing/late micro results handled via deviation/hold?
31) Sterile filtration integrity test linkage (if applicable)
31.1 Pre/post integrity test records attached to batch?
31.2 Equipment calibration and operator training current?
31.3 Failure triggers deviation + impact assessment?
31.4 Traceability between integrity test and batch ensured?
32) CCIT status and change impact
32.1 CCIT validation/verification exists and is current?
32.2 Routine monitoring plan defined?
32.3 Packaging change triggers CCIT impact assessment?
32.4 Complaint trend (leakers) linked to component lots?
Women Hormone (Potent) controls in QC
33) Women Hormone sample handling segregation
33.1 Dedicated hood/area for hormone sample preparation?
33.2 Dedicated tools/consumables (spatulas, vials, filters)?
33.3 PPE requirements defined and followed?
33.4 Potent waste segregated and disposed with records?
34) Hormone cross-contamination prevention
34.1 Line clearance/area clearance checklist before/after hormone work?
34.2 Shared equipment cleaning verification (balance/sonicator) documented?
34.3 Scheduling controls (end-of-day/segregated sessions) defined?
34.4 Spill response and decontamination records maintained?
35) Hormone cleaning verification effectiveness
35.1 Acceptance criteria defined (visual/swab limits) with rationale?
35.2 Cleaning records specify what was cleaned and by whom?
35.3 Cleaning failures trigger deviation + impact assessment?
35.4 Periodic effectiveness review/trending performed?
Documentation / Data integrity / QMS
36) Controlled worksheets and forms (GDP)
36.1 Controlled form issuance and reconciliation (serial numbers)?
36.2 Missing worksheets trigger investigation?
36.3 Corrections follow GDP (single-line, sign/date/reason)?
36.4 Blank spaces controlled (NA/strike-through)?
37) Logbooks discipline (equipment/instruments)
37.1 Logbook entries contemporaneous and complete?
37.2 No blank spaces; corrections controlled?
37.3 Periodic supervisor review documented?
37.4 Backdating prevention controls exist?
38) Excel templates control (if used)
38.1 Validation report exists for the template?
38.2 Formulas locked and access controlled?
38.3 Version control prevents use of local/old copies?
38.4 Changes require QA approval via change control?
39) LIMS/e-signature controls
39.1 Unique users and role permissions defined?
39.2 Result edits require reason and approval?
39.3 Audit trail review performed with evidence?
39.4 User disable/transfer access removal controlled?
40) Finished product OOS handling
40.1 Phase-I lab investigation checklist used?
40.2 Retest occurs only after investigation and with approvals?
40.3 Resampling only with proven sampling error?
40.4 CAPA effectiveness verified?
41) OOT trending program
41.1 Trending parameters defined (assay, impurities, dissolution, moisture)?
41.2 Review frequency and trigger limits defined?
41.3 Documented actions taken based on trends?
41.4 QA/QC approval of trend reports?
42) Deviation management (lab deviations)
42.1 Clear triggers (late tests, wrong reagent, excursions)?
42.2 Overdue tracking and escalation?
42.3 Impact assessment signed by QC+QA?
42.4 CAPA effectiveness checks performed?
43) Stability program control
43.1 Stability protocol and pull schedule adhered to?
43.2 Chamber qualification/mapping current?
43.3 Excursions investigated with QA impact assessment?
43.4 Missed pulls handled via deviation?
44) Stability data integrity and accountability
44.1 Sample accountability (stored/pulled/tested) reconciled?
44.2 Raw data package review same as release testing?
44.3 Stability OOT trending performed?
44.4 Stability summary/report approval workflow exists?
45) Retain sample controls (finished)
45.1 Retains kept in market pack with correct components?
45.2 Storage conditions monitored and excursions handled?
45.3 Access/removal log maintained?
45.4 Quantity sufficient for investigation?
46) Batch release workflow QC → QA → Dispatch
46.1 QA checklist includes deviations/OOS/OOT/stability/micro status?
46.2 ERP dispatch blocked before QA release?
46.3 CoA template/version control enforced?
46.4 Informal release prevented by policy/system?
47) Informal release prevention (verbal/email)
47.1 Policy exists and training completed?
47.2 Exception handling via deviation + QA approval only?
47.3 Evidence of periodic checks for informal release?
47.4 Warehouse awareness verified?
48) Analyst training/authorization
48.1 Authorization list for HPLC/GC/Dissolution/KF exists?
48.2 New analyst qualification and supervised runs documented?
48.3 Refresher training schedule exists?
48.4 Analyst error trends used for retraining?
49) Instrument breakdown handling
49.1 Breakdown triggers deviation/incident record?
49.2 Impact assessment on tested batches performed?
49.3 Requalification after repair completed?
49.4 Service reports archived and QA closed?
50) Near-miss and continuous improvement
50.1 Near-miss log exists (wrong label, late test, sample mix-up)?
50.2 Root cause and lesson learned documented?
50.3 SOP/training updates implemented?
50.4 Recurrence monitoring performed?
MICROBIOLOGY (50 Points)
1) Is microbiology lab zoning/segregation adequate?
1.1 Sterility testing area separated from culture handling/media prep?
1.2 Rules prevent non-sterile work entering sterility zone?
1.3 Access control and entry logs implemented?
1.4 Separate waste exit route to prevent cross contamination?
2) How is personnel flow controlled?
2.1 Entry logs maintained (who/when/why)?
2.2 Maintenance/visitors controlled with permission and records?
2.3 Door opening events managed/recorded if relevant?
2.4 Rules to minimize unnecessary movement displayed/trained?
3) Is gowning SOP clear and followed?
3.1 Gowning steps clearly documented (visual/steps)?
3.2 Gowning compliance checks performed (mirror/supervisor)?
3.3 Sterile gown/glove inventory and expiry controlled?
3.4 Gowning area cleanliness/segregation maintained?
4) Aseptic technique qualification for sterility testing analysts
4.1 Analyst qualification required before independent sterility testing?
4.2 Requalification frequency defined and executed?
4.3 Failure handling (retraining/restriction) defined?
4.4 Qualification records complete (date, assessor, result)?
5) Cleaning program—frequency and accountability
5.1 Cleaning schedule by room/grade documented?
5.2 Responsibilities defined (micro vs housekeeping)?
5.3 Verification/review signatures present?
5.4 Missed cleaning triggers deviation?
6) Disinfectant rotation program
6.1 Rotation includes alcohol + QAC + sporicidal?
6.2 Rotation plan/calendar available?
6.3 Rotation changes controlled via change control?
6.4 Justification exists if rotation not used?
7) Disinfectant preparation/dilution control
7.1 Calculation sheet available and followed?
7.2 Labels include name, concentration, prep date/time, expiry, prepared/checked by?
7.3 “Top-up” prohibited and monitored?
7.4 Expired disinfectant disposal logged?
8) Disinfectant contact time compliance (observe)
8.1 Contact time defined in SOP?
8.2 Wet contact time maintained (not immediate wipe)?
8.3 Timers/visual reminders used?
8.4 High-touch surfaces receive proper contact time?
9) Cleaning tools segregation (mops/wipes)
9.1 Dedicated tools by area with color coding?
9.2 Decontamination/laundering procedure defined?
9.3 Prevent dirty-to-clean tool transfer?
9.4 Clean dry storage of tools ensured?
Environmental Monitoring (EM)
10) Is EM plan risk-based and documented?
10.1 EM map includes critical points (doors, return air, interventions)?
10.2 Frequency defined per grade/operation?
10.3 Methods defined (active air/settle/contact/swab/personnel)?
10.4 Annual review of EM plan performed?
11) EM sampling technique training
11.1 Training records for active air/settle/contact/swab sampling?
11.2 Standardized pressure/area for contact plates?
11.3 Swab area templates used and trained?
11.4 New sampler supervised until qualified?
12) Active air sampler calibration/controls
12.1 Calibration certificates current?
12.2 Flow verification before use documented?
12.3 Cleaning/decontamination SOP exists?
12.4 Missed sampling due to breakdown handled via deviation?
13) Settle plate controls
13.1 Exposure time standardized in SOP?
13.2 Placement rules defined and followed?
13.3 Labeling complete (location, date/time, operator)?
13.4 Handling of knocked/overexposed plates defined?
14) Surface monitoring (contact plates)
14.1 Pressure/time technique standardized?
14.2 Site list and frequency defined?
14.3 Media lot release confirmed before use?
14.4 Failures trigger cleaning/investigation and controlled resampling?
15) Swab monitoring controls
15.1 Swab area size standardized (template)?
15.2 Neutralizer use defined where needed?
15.3 Transport/holding time controlled?
15.4 Swab labeling/traceability ensured?
16) Personnel monitoring program
16.1 Monitoring points defined (gloves/sleeves/forearm/chest)?
16.2 Timing defined (exit/after interventions)?
16.3 Failure response defined (retrain/restrict/increased monitoring)?
16.4 Trending by person/shift to detect recurrence?
17) EM incubation parameters and control
17.1 Incubation temperatures/durations defined?
17.2 Incubator monitoring logs maintained?
17.3 Plate inversion/stack height controlled?
17.4 Incubation excursions investigated?
18) EM data review discipline
18.1 Daily/weekly review and sign-off performed?
18.2 Monthly/quarterly trending reports generated?
18.3 Conclusions and actions documented?
18.4 QA review/approval where required?
19) Alert/Action limits governance
19.1 Limits based on historical data/capability or justified reference?
19.2 Limits differ by grade/area as appropriate?
19.3 Alert vs action responses defined and followed?
19.4 Limits reviewed periodically with QA approval?
20) EM excursion investigation quality
20.1 Immediate containment actions defined (reclean/restrict/resample rules)?
20.2 Resampling controlled (not “resample until pass”)?
20.3 Root cause analysis documented (5-why)?
20.4 CAPA effectiveness verified via follow-up EM results?
21) Organism identification (ID) for excursions
21.1 ID required for action-level excursions/sterility positives?
21.2 ID method verified (MALDI/API/biochemical) with controls?
21.3 Recurrence database maintained and reviewed?
21.4 Objectionable organisms escalation procedure exists?
Media / Autoclaves / GPT
22) Media receipt and storage control
22.1 Vendor CoA reviewed and signed?
22.2 Expiry and damage checks performed?
22.3 Storage conditions (temp/RH) monitored?
22.4 Open-date control for dehydrated media?
23) Media preparation records
23.1 Weighing records include balance ID, quantities, operator?
23.2 pH adjustment recorded (target vs actual)?
23.3 Autoclave cycle printouts attached?
23.4 Labels complete (media name/lot, prep date, expiry)?
24) Autoclave routine monitoring
24.1 Each cycle reviewed/signed (time/temp/pressure)?
24.2 Load pattern controlled per SOP?
24.3 Chemical indicator use and acceptance criteria?
24.4 Failed cycle handling (quarantine/investigation/discard)?
25) Autoclave validation/mapping
25.1 Mapping report includes worst-case load?
25.2 Cold spot identified and BI placement justified?
25.3 Requalification after repair/relocation performed?
25.4 Validation approved by QA?
26) Media sterility check program
26.1 Sterility check sampling plan defined?
26.2 Incubation conditions/time defined?
26.3 Sterility failure triggers quarantine/discard of media lot?
26.4 Investigation includes autoclave/pouring/handling review?
27) GPT (Growth Promotion Test) compliance
27.1 GPT frequency defined and followed per media lot?
27.2 ATCC strains controlled and correct strains used?
27.3 Inoculum CFU target controlled/verified?
27.4 GPT failure investigation and media hold documented?
28) Culture/strain management
28.1 Master vs working stock separation?
28.2 Passage limits defined and controlled?
28.3 Freezer (-80°C) monitoring and alarm response logs?
28.4 Purity/contamination checks performed?
Sterility Testing
29) Sterility test method control (Membrane filtration/Direct inoculation)
29.1 SOP current and method clearly defined?
29.2 Method suitability (inhibition/neutralization) current per product?
29.3 Units/volumes per pharmacopeia followed?
29.4 Sample holding time controlled (sampling → test start)?
30) Sterility test environment (BSC/Isolator) controls
30.1 BSC certification current (HEPA/airflow/smoke)?
30.2 Cleaning/decontamination validated and recorded?
30.3 Work practices (arrangement, slow movements) defined in SOP?
30.4 UV reliance (if any) supported by effectiveness validation?
31) Sterility test execution discipline
31.1 Analyst aseptic qualification current?
31.2 Media lot released (GPT + sterility check pass) before use?
31.3 Incubation dual temperature controlled (if required)?
31.4 Results reading second-person verification performed?
32) Sterility positive investigation
32.1 Organism ID mandatory for positives?
32.2 “Lab contamination” conclusion requires defined evidence?
32.3 Batch impact assessment and QA disposition documented?
32.4 Retesting rules controlled to prevent testing into compliance?
Endotoxin / LAL
33) LAL method control
33.1 LAL validation/verification exists (product-specific where required)?
33.2 PPC criteria defined; failure handling defined?
33.3 Standard curve acceptance criteria defined?
33.4 Calculation template controlled/validated?
34) LAL reagents/consumables control
34.1 LRW storage/expiry controlled?
34.2 CSE/RSE traceability and sensitivity verification?
34.3 Pipette calibration (µL) current?
34.4 Endotoxin-free consumables controlled and verified?
35) Depyrogenation controls (if applicable)
35.1 Depyrogenation oven cycle validated?
35.2 Load configuration controlled?
35.3 Cycle record review and sign-off?
35.4 Post-cycle protection (covered storage) to avoid recontamination?
Non-sterile Micro (MLT / Bioburden) + Data Integrity + Utilities
36) Non-sterile MLT method suitability
36.1 Product inhibition/neutralization studies available?
36.2 Neutralizer selection justified and documented?
36.3 Formula change triggers re-suitability testing?
36.4 Suitability results reviewed/approved?
37) Non-sterile sample holding time controls
37.1 Sampling/receipt/test start timestamps recorded?
37.2 Holding conditions (temp) defined and followed?
37.3 Delays trigger deviation + impact assessment?
37.4 Transport/handling SOP exists?
38) Plate counting rules and consistency
38.1 Countable range and TNTC rules defined?
38.2 TNTC handling (next dilution/repeat) defined?
38.3 No overwriting; GDP corrections used?
38.4 Second-person verification for critical results?
39) PW/WFI sampling technique control
39.1 Tap sanitization method and time defined?
39.2 Flush time/volume standardized?
39.3 Sterile bottles used; neutralizer used where needed?
39.4 Sampler training documented?
40) Water microbiology testing and trending
40.1 Test method/incubation conditions defined and followed?
40.2 Alert/action limits defined and justified?
40.3 Trend reports generated to detect upward drift?
40.4 Upward trends trigger biofilm action plan and sanitization review?
41) Water OOS handling and batch impact assessment
41.1 QA/production notified promptly?
41.2 Affected batches/cleaning/production assessed and documented?
41.3 Corrective action (sanitization/maintenance) recorded?
41.4 Effectiveness check verified (post-action results)?
42) Water sanitization program governance
42.1 Sanitization schedule adherence evidence?
42.2 Post-sanitization monitoring defined and followed?
42.3 Deviations handled and documented?
42.4 Engineering interface and approvals documented?
43) Compressed air/gas micro monitoring (if applicable)
43.1 Sampling points list is risk-based and approved?
43.2 Frequency/limits defined?
43.3 Failures investigated with CAPA?
43.4 Trends reviewed periodically?
44) Micro GDP for plates/worksheets
44.1 Plate labels complete and traceable (date, location, operator)?
44.2 Counts recorded contemporaneously (not later from memory)?
44.3 Corrections follow GDP (single-line, sign/date/reason)?
44.4 Uncontrolled loose papers prohibited and monitored?
45) Plate retention and disposal controls
45.1 Retention time defined in SOP?
45.2 Plates retained during investigations as required?
45.3 Disposal logs maintained (date, method, witness if required)?
45.4 Early disposal triggers deviation?
46) Preventing “recount until pass”
46.1 Recount rules defined (when allowed, who can recount)?
46.2 Discrepant counts handled by SOP (tie-break rules)?
46.3 Second-person verification applied to critical counts?
46.4 Recount history documented?
47) Micro computerized systems data integrity (if used)
47.1 Unique logins and role permissions?
47.2 Result changes require reason capture?
47.3 Audit trail review performed with evidence?
47.4 User access removal controlled when personnel change?
48) Micro OOS/deviation investigations
48.1 Investigation checklist covers media/incubator/technique/environment?
48.2 Evidence attached (photos, plates, ID reports)?
48.3 Root cause documented (5-why) with CAPA?
48.4 Effectiveness check performed and documented?
49) Change control impact on microbiology
49.1 Changes to media/disinfectants/equipment captured in Change Control?
49.2 Verification/revalidation performed where required?
49.3 Training updated before implementation?
49.4 Post-change monitoring plan defined?
50) Batch disposition interface (Micro → QA release)
50.1 QA release requires completion of sterility/LAL/critical EM?
50.2 Critical findings communicated promptly to QA/production?
50.3 Hold/release decisions traceable and documented?
50.4 Conditional release (if any) controlled by SOP and risk assessment?
