Source Approval, Purpose :
Source Approval, The purpose of this SOP is to describe the procedure for selection, approval of new vendors / sources for raw materials, packaging materials and evaluation of existing ones.
Source Approval, Scope :
This SOP is applicable to all vendors / sources for raw materials, packaging materials which may have an impact on product quality manufactured by XX Pharmaceuticals Limited. This SOP is applicable for both General and Sterile block of XX Pharmaceutical Limited.
Definitions / Abbreviation:
[][]Vendor: A vendor, or a supplier, is an enterprise in the supply chain that contributes goods and services available to companies or consumers. A vendor can operate both as the supplier of goods (seller) and the manufacturer. Generally, a supply chain vendor manufactures inventory/stock items and sells them to the next link in the chain. Today, the terms refers to a supplier of any good or service.
[][]SOP – Standard Operating Procedure
[][]PD – Product Development
[][]QA – Quality Assurance
[][]QC – Quality Control
[][]SCD – Supply Chain Department
[][]COA – Certificate Of Analysis
[][]API – Active Pharmaceutical Ingredient
[][]MSDS – Material Safety Data Sheet
[][]TSE – Transmissible Spongiform Encephalopathy
[][]BSE – Bovine Spongiform Encephalopathy
Responsibilities: Source Approval
The roles and responsibility is as follows:
Executive, PMD
[][]To inform PD, QA and supply chain department about new product with expected production forecast.
Executive, PD
[][]To raise requisition for any new materials required for new product development with PD trial quantity and forward to supply chain department.
Manager, Supply Chain
[][]Sourcing of raw and packaging materials from vendors and to initiate Vendor approval form.
[][]To collect documents as required.
[][]To procure raw materials and packaging materials from approved sources.
Executive, QC
[][]To analyze the source samples from new or existing vendor including raw materials.
[][]To prepare and review of approved source list for raw materials, packaging materials.
[][]Vendor rating.
Executive, Quality Assurance
[][]Evaluation of vendor documents.
[][]Preparation of vendor audit schedule.
Manager, Quality Assurance
[][]Approval/not approval of vendor.
Procedure:
The following procedure is to be followed for procurement from a new source or vendor.
Required Document
[][]To evaluate raw materials vendor following document are required
[][]Duly filled Vendor Approval Questionnaire
[][]Duly filled Vendor Approval form
[][]Certificate of Analysis (COA)
[][]Method of Analysis (in case of non-compendial method)
[][]Stability data (both accelerated and long term) justifying shelf-life
[][]Material Safety Data Sheet (MSDS)
[][]Working Standard of Active Material with COA
[][]Manager, Supply Chain forwards the sample along with these documents to Quality Control Department.
[][]To evaluate primary packaging material vendor following document are required. For secondary packaging material vendor 1st four are required.
=>Duly filled Vendor Approval Questionnaire
=>Duly filled Vendor Approval form
=>Certificate of Analysis
=>Method of Analysis
=>Design and specification
=>TSE/BSE free Certificate
=>Material Safety Data Sheet (MSDS)
=>Certificate of Composition
Approval of new vendor of raw materials:
[][]After getting information about new product with expected production forecast from PMD; PD will sent purchase requisition to supply chain department for procurement of new materials required for PD trial and share necessary information of new product to QC for preparation of specification.
[][]QC generates draft specifications for new material with the concern of PD. Any in-house specification that should be included on the basis of literature survey or PD requirement. For INN material QC develops specification based on Manufacturer’s COA / specification and PD requirement.
[][]Supply Chain department identify suitable vendors for required material and ask for COA of that specific material to forward to QC. Evaluating manufacturer’s COA, QC will ask for QC test sample (mentioning quantity) from suitable vendors through SCD.
[][]Supply Chain collects QC test sample / PD sample with documents from suitable vendors and then forwards to QC along with filled Vendor Approval Form (as per Annexure- I).
[][]QC receives source sample and documents and makes entry in a register with lab control no., name of material, lot. No., code no., manufacturer, supplier / local agent / indenter, manufacturing date, expiry date, quantity received, received by and date and review documents, if any anomalies observed then inform supplier through SCD.
[][]After testing QC makes entry of analyzed by and date; checked by and date; remarks in that register and shares QC test result of source sample with supplier and SCD.
On the basis of QC test result, SCD can procure PD trial sample of API from selected vendor.
[][]In receipt of PD trial sample of API, QC will arrange test for the same and then forwards PD trial sample to PD for formulation development along with analytical result and filled Vendor Approval Form.
[][]Sr. Executive / Asst. Manager, QC will put his comment on Vendor Approval Form after QC test of PD trial sample of API and QC test sample of excipients.
[][]On the basis of PD trial and stability report of formulated product with PD trial sample, PD will put his comment on Vendor Approval Form, then forward to Quality Assurance Department.
[][]Quality Assurance reviews the analytical data, PD trial report, available relevant documents and records and then put comment on Vendor Approval Form.
[][]If all reports comply the requirements, Manager, QA will grant approval for purchase of one initial consignment and the source will be included in approved source list as Category B (New sources on trial). If requirement does not comply, Manager, QA shall not approve the sample for procurement from that vendor.
[][]Product analytical results of at least three consecutive commercial batches to be evaluated to approve the supplier as Category A (Established source).
Approval of new vendor of packaging materials:
[][]For packaging materials other than printed one, Supply Chain collects source sample /Machine trial sample (Foil/Film -5 kg; Other materials -50 pcs or as per requirement) and required documents including Vendor approval questionnaire from supplier and then forward to QC along with filled Vendor Approval Form.
[][]QC receives source sample and documents and makes entry in a packaging material vendor sample register with lab control no., name of material, lot. No., code no., manufacturer, supplier / local agent / indenter, manufacturing date (where applicable), expiry date (where applicable), quantity received, received by and date.
[][]After testing, QC forwards machine trial sample along with machine trail report form (Annexure-IV) to production for machine trial.
[][]If the machine trial report is satisfactory, PD will arrange 6 months stability study for all primary packaging materials.
[][]Manager, QA will grant approval for purchase of one initial consignment on the basis of QC test result, machine trial report and stability study and the source will be included in approved source list as Category B (New sources on trial).
[][] If requirement does not comply, Manager, QA shall not approve the sample for procurement from that vendor. SCD can procure commercial sample after vendor approval.
[][]The analytical results of at least three consecutive commercial batches to be evaluated to approve the supplier as Category A (Established source).
Vendor Rating:
[][]A cross functional team shall jointly perform the vendor rating which consist of QC, SCD & QCOM
[][]To evaluate the performance of vendor Quality rating, Delivery rating, Price rating and Vendor rating shall be calculated in the following way.
Carry out the incoming inspection, analysis and calculate the ‘Quality rating’ as follows:
QR = Q1 + X1Q2 + X2Q3/Q
Where,
Q = Quantity Received
Q1 = Quantity Accepted without any comment/ problem
Q2 = Quantity Accepted with deviation; X1 = 0.7 (factor for deviation)
Q3 = Quantity Accepted with rectification; X2 = 0.5 (factor for rectification)
[][]Send the Quality Rating to Manager, SCM.
[][]SCM shall carry out the Delivery rating and Price rating as follows
Calculation of Delivery Rating of Vendor:
DR = q1 + 0.5q2/q
Where,
q = Quantity Ordered
q1 = Quantity received as on before time
q2 = Quantity received beyond due date
Calculation of Price Rating of Vendor:
PR = Minimum quotation received/ Price paid
[][]After completion of Delivery rating and Price rating, Executive, QCOM shall calculate and classify the vendor rating and approved by Head of QA.
Calculation of Vendor rating: VR = (0.5 QR + 0.3 DR + 0.2 PR) X 100
Classification of the Vendor Rating:
VR = 100 Good
90 ≤ VR < 100 Satisfactory
50 ≤ VR < 90 Deficient
VR < 50 Rejected
[][]Delete the vendor from “Approved Vendor list” when the level reaches “Rejected”.
[][]Finalize the list and forwarded the same to Quality Assurance Department for approval. Quality Assurance shall then circulate the “Approved Vendor/ Supplier list” to relevant department.
[][]The records of “Vendor Rating” will be kept for a minimum period of 3 years and the evaluation will be done at 3 years interval.
Procedure for exclusion of vendor from approved vendor’s list:
[][]The vendor shall be disqualified and removed from the approved vendor’s list for following reasons during regular assessment.
[][]If consecutive three consignments of material fail to comply the specifications or if the approval rate is below 70%.
[][]Three out of ten consignments fail to comply the specification.
[][]The delivery schedule is not met for 40% of supplies.
Corrective and preventive action:
[][]The vendor shall be made aware of the reasons for his exclusion and shall agree improvement action plans.
[][]The vendor, who has been excluded from the approved vendor list, may be included again by taking following corrective action and preventive actions.
[][]Manager, Quality Assurance or his representatives shall conduct facility audit of the vendor in order to ensure that quality system exists in the organization.
[][]Carry out the discussion on other non-quality issues like delivery schedule and rate etc.
[][]After Satisfactory outcome of all above points the vendor shall be approved as per the new vendor evaluation procedure.
Auditing
[][]Supplier audits will be conducted by experienced auditors nominated by Manager, Quality Assurance. Auditors will have experience/training in GMP auditing.
[][]Pre-audit meeting: A meeting of Manager, Quality Assurance, auditors and any other relevant personnel such as Procurement/ Technical expert shall be conducted 2 weeks prior to the audit.
[][]This meeting shall review all information available and any previous audit recommendations (in case it is done earlier) and status, complaints raised, number of deliveries since the last audit and any issues.
[][]The audit report (Annexure-V Audit Report Template) shall be finalized within 4 weeks after the audit and sent to SCM for forwarding it to the supplier/vendor with an advice that the supplier/vendor will give their feedback within 1 month of receipt of the report and prepare an action plan to close the gaps identified during the audit.
[][]Reference No. for Audit Report shall be as
AR/RM or PM/20xx-1
Where-
=>AR represents audit report
=>RM represents raw materials
=>PM represents packaging materials
=>20xx represents auditing year
=>1 represents sequential number
[][]SCM will follow up with the Supplier/vendor on the progress of recommended actions and any response or follow up correspondence shall be filed with the audit report in the appropriate supplier file.
[][]When a supplier/vendor is audited for the first time, a follow up audit should be conducted as per agreed time line with the supplier for the confirmation of the status of the Supplier.
[][]A supplier quality audit shall be performed at every 3 years interval which based on supplier’s documentations followed by desktop audit.
Supplier Status
[][]Updated approved source list must be maintained / amended / updated by Quality Control, that will be reviewed in every 6 months accordingly. Copy of approved source list will be shared to SCD, Warehouse, Production, Quality Assurance department. The list will hold two categories of suppliers:
=>Category B – New supplier/vendor under study.
=>Category A – Supplier/vendor having 3 consecutive satisfactory supplies
[][]If a supplier’s status is downgraded due to a quality problem, an unsatisfactory audit or any other issues, immediate action must be taken. The following actions must be considered:
=>Inform Manager, Quality Assurance
=>Amend Suppliers List
=>Source an alternative supplier on urgent basis
=>Review retrospective impacts on product quality
Supplier Files
[][]All related supplier approval documentation must be collated and filed in the appropriate supplier file. This should include the following where relevant:
=>Quality assessment questionnaire
=>Audit Checklist, Audit Report and Audit Summary Report
=>Response from the supplier
=>Relevant documents, i.e, Deviation Reports or Customer Complaint forms
=>Any other correspondence
Annexure: Source Approval
Annexure-I: Vendor Approval Form
Annexure-II: Vendor approval questionnaire – Raw materials
Annexure-III: Vendor approval questionnaire – Packaging materials
Annexure-IV: Machine trial report form
Annexure-V: Vendor Audit Report Template
Annexure-VI: Vendor Rating Form