Quality Assurance

Batch Release, Purpose:

Batch Release, This procedure defines the correct procedures for the release and distribution of finished products to ensure Assurance with the requirements of GMP and includes details of the responsibility of the Authorized Persons.

Batch Release, Scope:

This SOP is applied to storage, release and distribution of finished products and it’s supporting activities at XX Pharmaceuticals Limited (Both General & Sterile).

Definitions / Abbreviation:

[][]QA : Quality Assurance
[][]SOP : Standard Operating Procedure
[][]FIFO : First In First Out
[][]COA : Certificate of Analysis

Responsibilities:

[][]The roles and responsibility is as follows:

Production Executive

[][]Check the quantity of the product before transfer into the ware house.
[][]Transfer the finished goods to warehouse.
[][]Issue Transfer Note accordingly

Warehouse Executive

[][]Receive finished goods from the production floor after proper checking.
[][]Keep the finished product into the ware house accordingly.
[][]Transfer the finished goods to central warehouse after getting release note from QA.

Quality Assurance Executive

[][]Check the quantity of the product before transfer into the ware house.
[][]Compilation of Batch Production Record.
[][]Follow the overall batch release procedure.
[][]Quality Control Executive/ Microbiologist
[][]To provide analytical support for various samples drawn for batch release.
[][]Prepare Certificate of Analysis (COA).

Head Of Quality Assurance

[][]Give approval to release the finished goods into the market.
[][]To ensure Assurance of the SOP.
[][]Approval the SOP.

Annexure:

Annexure-I: Checklist for Batch Documentation
Annexure-II: Finished Product Release Note
Annexure-III: Final Inspection Sheet

Procedure:

[][]After completion of packaging operation, finished packed shipper cartons will be stored at the Quarantine area of packaging hall. Production Executive will raise the Finished Goods Transfer Note  to Quality Assurance Department for final inspection mentioning product name, batch number, quantity, master carton number.

[][]The finished product will be transferred to warehouse after physical checking by Quality Assurance Executive according to final inspection sheet (Annexure- III).
[][]Warehouse Executive will check the product name, batch number, quantity, pack size, and label of finished product(s) against the transfer note during receiving.
[][]If all information (Product name, batch number, quantity, pack size, label) of finished product transfer note is matched with transferred quantity, then Warehouse Executive will receive & store the product in QUARANTINE AREA (for finished product) of warehouse maintaining storage condition as per attached product label on the shipping carton.
[][]After completion of full batch packaging, Production Executive will submit the Batch Packaging Record to Quality Assurance Department mentioning the transferred quantity in the BPR for release of the product.
[][]Quality Assurance personnel will review all the documents / parameters according to checklist . If all parameters are found complies, then he/she will compile the full batch production record (BMR, BPR) along with all related documents.
[][]After compilation of the batch documents, QA Executive will entry in the ERP of release note verification and Head of QA will approve the release in the software.
[][]Quality Assurance will attach the Approved Label  in every pallet containing released product. (One labels per pallet).
[][]During reviewing the documents according to the check list, following matters need to be considered.
[][]Batch Manufacturing Record (BMR)
[][]Evaluate all the in-process result are within limit, cleaned/partially cleaned label are available, dispensing weights are accurate & dispensing slip along with print out is available, all manufacturing part has been done as per instruction, all the responsible persons have signed in respective operation stages in BMR.
[][]If any deviation/change control was raised, reference number is recorded in the respective place of BMR.
[][]Review the reconciliation steps are correctly calculated and loss result is justified.
[][]Review the line clearance in each steps of manufacturing and Packaging stages are signed by responsible person.
[][]Review the related Deviation/Change Control is closed and the reference number of this documents are recorded in the respective area of the BMR.
[][]Review the completed BMR is approved by Quality Assurance and Production after completion of operation.
[][]Review the associated documents such as all relevant labels, IPC record, particle count record (If any) is correct and signed. Review all the results are within limit or not. If any results are found out of limit, then related Out of Specification (OOS) is attached with the document.
[][]Review the completed BMR is approved by Head of Production or his/her designate and Head of Quality Assurance or his/her designate after completion of operation.

Certificate of Analysis (COA)

[][]Review the Certificate of Analysis (Chemical and Microbial) is signed and approve by responsible person. Review all the results are within the specification. Review all the print out of QC analysis result attached with COA.

Batch Packaging Record /BPR (Primary and Secondary)

[][]Review all the packaging materials are correctly dispensed and authentication information for packaging start up is correct.
[][]Review the in process checks are routinely performed.
[][]Review the reconciliation steps are correctly calculated and Yield & loss result is justified.
[][]Review the line clearance in each step (i.e. primary packing, secondary packing), inspection and labeling are signed by responsible person.
[][]Review the related Deviation/Change Control is closed check the presence of the Deviation/Change Control reference number into the respective place of BPR.
[][]Review the completed BPR is approved by Head of Production or his/her designate and Head of Quality Assurance or his/her designate after completion of operation.

Review the quantity of the packs and presence of all signatures accordingly.

[][]Head of QA/Designee shall verify the Batch Production Record as per checklist (Annexure-I) for correct entries, reconciliation of quantity, yield, change control, deviation, out of specification (OSS), (if any), in-process checking records analytical test results etc. After reviewing if all the parameters found satisfactory then the Manager, /designee shall release the product for dispatch.
[][]For dispatch of finished product, Quality Assurance personnel will issue the Finished Product Release Note (Annexure-II) for getting approval from Head of Quality Assurance. Finish Product Release Note is a self carbonated pre-printed copy as per the original approved copy of Annexure-II
[][]Which contains three different colors Then one carbonated (Yellow colored) copy of the finished product release note will send to central warehouse for distribution. The original blue colored copy will be attached with the batch document.
[][]In case of release of any optimization or validation batch before completion of process validation report, & risk analysis report must be conducted before release. All the documents are approved accordingly by Head of Quality Assurance or his/her designate.
[][]Full batch will be released at a time after completion of the total packaging operation of the batch.
[][]After QA release, Warehouse Executive will store the released product orderly in separated passed area maintaining storage condition. FIFO must be maintained by warehouse executive during dispatch of the released product for distribution.
[][]Quality Assurance Executive will compile all the batch records and kept in the respective Batch Production Record archive area after keeping record in the document archiving log book.
[][]Batch history which must be kept for one year after expiry of the batch.
[][]Fraction batch quantity can only be released with same batch number (while the batch is fractioned as Commercial, Trial Aid or Export) after approval of Head of Quality Assurance.

Room Numbering , Purpose:

Room Numbering , To provide guidelines for numbering system to all rooms of General Block and Sterile Block in XX Pharmaceuticals Limited.

Room Numbering , Scope:

This procedure is applicable for assigning sequential identification number to all rooms located on each floor of the production, PD/QC/Microbiology area and other area related to Plant operations such as warehouse, plant room, utility area etc are also included in room numbering system.

Definition / Abbreviation:

[][]None

Responsibilities:

[][]The roles and responsibility are as follows:

Executive / Sr. Executive, Engineering

[][]He / she shall be responsible for assigning the sequential identification number to all rooms.

Quality Assurance personnel

[][]He/she shall be responsible for effective implementation and monitoring of procedure.

Quality Assurance Head or Designee

[][]To ensure implementation of SOP.

Procedure:

[][]Numbering for Room
[][]Each room shall be assigned a unique identification number.
[][]Engineering department shall assign floor wise alpha numeric sequential identification Number to all rooms in a logical order on lay out and record the numbering details in Annexure –I.
[][]Do not repeat the same number to another room.
[][]The room numbering shall be a floor wise sequential number having 6 characters as shown below.
=>e.g. GPRXXX
where
=>(G) is the code for General Block
=>(PR) is the working area code for production
=>(XXX) is the first sequential number of room start from 001 to 999
=>Next room shall be numbered GPR002 ……….& so on.

[][]The Building code for each building is given below.

Building name/ Code

=>General Block/G
=>Sterile Block/C
[][]The Working area code for each area is given below.

Area/ Code

=>Production/PR
=>Packaging/PK
=>Warehouse/ WH
=>Product Development/ PD
=>Quality Control/QC
=>Microbiology/MB
=>Mezzanine /ME
=>Roof Top/RT
=>Engineering/EN

Annexure:

Annexure – I: List of rooms

Leak Test Apparatus , Purpose :

Leak Test Apparatus , The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of leak test apparatus.

Leak Test Apparatus , Scope :

This procedure is applicable for leak test apparatus (Model: Electrolab, LT-101P ) used in the In Process Check of General Block at XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A

Responsibilities:

[][]The roles and responsibility is as follows:

Executive, Quality Assurance

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Asst. Manager, Quality Assurance

[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.

Manager, Quality Assurance

[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Laboratory coat must be worn while handling the instrument.
[][]Disconnect the power supply before moving or cleaning of the instrument.
[][]Prior to use, user must ensure that equipment is calibrated.
[][]Preparation of Rhodamine B Dye Solution:
[][]Prepare a 2 liters solution of Rhodamine B dye by dissolving 0.5 gm of the dye in water. Take 800 ml water in a 1000 ml beaker and make it colored by adding about 5 ml of the dye solution.

Operating Procedure:

[][]Place the sample in the desiccators which is filled with Rodamin solution to the desired level.
[][]Connect the vacuum tubing between desiccators and the Vacuum Inlet Nozzle provided on the back panel of the instrument.
[][]Switch ON the power switch, then LCD screen displays LEAK TEST APPARATUS followed by SERIAL NUMBER of the instrument and changes over to Vacuum in mm, Hg and Time.
[][]Press the SET key to change to vacuum and input required data by using UP, DOWN and SHIFT keys.
[][]To change HOLD TIME press the SET key and input required data by using UP, DOWN and SHIFT keys.

[][]To show USER ID on screen, press SET key. To setup USER ID press UP or DOWN key.
[][]To change SAMPLE ID press the SET key and input required data by using UP, DOWN and SHIFT keys.
[][]To change No. of samples press the SET key and input required data by using UP, DOWN and SHIFT keys
[][]To change BATCH NO. press the SET key and input required data by using UP, DOWN and SHIFT keys.
[][]After all the data is entered, press the ENTER key and then press the RUN key to run the program which is set for required test. Then vacuum release takes place for three seconds and the pump starts and the vacuum built up which is displayed on the LCD screen. If no vacuum builds up then press desiccator top lid for a few seconds.
[][]When vacuum release reaches zero place automatically then press the print key to get full details of the test.
[][]Leak test parameters

Type of product/Pressure/Time

[][]Tablet, Capsule, Vial/450 mm-hg/5 minutes
[][]Powder for Suspension/450 mm-hg/2 minutes

Procedure for setup time, date and serial number:

[][]Switch ON the instrument and press up arrow key until hear a buzzer sound, then shows password.
[][]Enter password.
[][]The password is four digit 8824 and press enter key.
[][]Date format is 2013 02 16 (Year Month Day) and Time format is 12:15(Hours, Minutes).
[][]Input necessary data by using up, down and right shift key, Date and time can be changed.
[][]To show Serial No. on screen press Enter key
[][]Input necessary data by using up, down and right shift key, Serial No. can be changed.
[][]When all data is entered completing then press Enter key.
[][]Switch OFF the instrument.
[][]Switch ON the instrument after few minutes and check the above recorded data and verify.

Calibration procedure:

[][]Calibrated stopwatch and start timer of leak test apparatus and stop watch simultaneously.
[][]Note the reading at intervals of 60 seconds, 180 seconds and 300 seconds respectively.
[][]Acceptance criteria: 10 seconds for each interval.
[][]Vacuum gauge calibration done by external party.
[][]Frequency of calibration: Twelve months (for timer, vacuum gauge and vacuum holding capacity).

Cleaning procedure:

[][]After completion of the testing, switch off the instrument.
[][]Cleaning of leak test apparatus by using purified water and clean outer and inner surface with the help of lint free cloth.
[][]Place the apparatus for dryness for half an hour.
[][]Change the desiccator Rodamin solution twice in a week or as per required.

Annexure:

Annexure-I: Log Book of Leak Test Apparatus.

Training Procedure, Purpose:

Training Procedure, To lay down guidelines for training of new entrants and periodic retraining of technical staff.

Training Procedure, Scope:

[][]This procedure is applicable for all employees of General block and Sterile block at XX Pharmaceuticals Ltd. for
[][]On the job training (OJT)
[][]Class room training (CT)
[][]External training
[][]Basic GMP training

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibility is as follows:

Executive, HR & Admin.

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
[][]To check the records of training filled by trainee.
[][]To maintain employ training record.
[][]To prepare list of training given to the employees.
[][]To file all records of training in their individual training file.
[][]Training is given in all departments as per the induction form.

Manager, Human Resources

[][]To preserve all training record
[][]To co-ordinate in all training program

General Manager, Plant

[][]To ensure that this procedure is kept up to date.
[][]To ensure implementation of the training as per SOP.
[][]To assess the training requirement.

Manager, Quality Assurance

[][]Approval of the SOP.

Procedure:

[][]The manufacturer should provide training for all the personnel whose duties take them into production areas or into the control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel whose activities could affect the quality of the product.

New Entrants:

New entrants to the organization shall be given induction training and brief cGMP/GLP training by Head of Quality assurance or Quality Assurance within 10 days of joining.
[][]New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month.
[][]New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program.
[][]A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills.
[][]Quality Assurance shall prepare a regular annual schedule for training/retraining of technical staff.
[][]The Qualified trainer who has conducted the training should review and assess the feedback.
[][]Based on the assessment, trainer shall identify training retraining needs.
[][]Individual Training record should be maintained for each new entrant along with their feedback.
[][]Once the induction is over the new employees hand over induction training format duly filled with all required signatures to HR & Admin. Department.

Classroom training:

[][]Prepare the training schedule and circulate to all Department Heads for information.
[][]Upon finalization of training schedule, intimate to participants.
[][]Prepare required training aids and conduct the training program.
[][]On completion of the training, evaluate the training imparted by giving a questionnaire. Trainer is required to set the questionnaire.
[][]Trainer evaluates the answer & ranks them as Excellent (>90%), Very good (>80-90%), Good (>60-80%), Poor (<50%).
[][]Poor performers are retrained and re-examined.
[][]After training, trainer provides “Individual Training Record” to the trainee for getting feedback.

[][]All trainees fill the same immediately after the program gets over & submit it to the trainer.
[][]Trainer notes the contents, signs each reports & forward the same to HR & Admin. Department who keep all training related records.
[][]Maintain the training record in training file and update the Employee training card.

On-the-job training:

[][]On need base a competent person organizes on job training to concerned persons either individually or in small group preferably of 5 to 7.
[][]Trainer first explains the theoretical aspects making use of writing boards/printed literature diagram etc.
[][]Explain or demonstrate the actual operation or system to participant.
[][]Training record is maintained in the form as explained above.

External training:

[][]Upon information from various agencies nominate the person on consultation with department head.
[][]Make the necessary arrangement like tickets, hotel arrangement etc. to attend the external training.
[][]After training, trainee will submit the report in the prescribed format as per Annexure- V, to HR & Admin. Department through Department Head. Brief [][]information about the program need to be enclosed with the report.
[][]Maintain the training record in training file and update the Employee training card of concerned employees who have undergone external training as per SOP.
[][]Trainee shares the literature & knowledge gained in the program with all this colleagues.
[][]Department Head may ask the concerned employee to make a presentation on the topic concerned for the benefit of all those concerned who were not sent for training.

Training on basic GMP practice:

[][]Department Head training the new comer on following points:

Production :

[][]Importance of good manufacturing practices and requirements.
[][]Systems related to manufacturing.
[][]System related to packaging (printed and unprinted component code etc).
[][]Documentation.

Warehouse:

[][]General warehousing procedure.
[][]Function carried out by Warehouse.
[][]Document related to warehouse.

Engineering:

[][]Facilities and services
[][]Brief working of the services
[][]Documentation

Quality Assurance:

[][]General information on SOP, GMP Documentation.
[][]Activities of Quality Assurance, Product Development, Microbiology & Quality Control.
[][]Product information.
[][]Other specific activity related to the employees department.

Training schedule:

[][]New entrant: General factory rules and cGMP –10days
[][]Regular training for staff and operators
[][]cGMP – Once in 6 months
[][]GLP – Once in 6 months
[][]Technical training – Once in 3 months
[][]A training session by an External Agency shall be conducted as and need/opportunity arises.
[][]Apart from the schedule, training/retraining sessions will be conducted as and when need arises.

Annexure:

Annexure-I: Individual Training Record.
Annexure-II: Training Log.
Annexure-II: Induction Training Format.
Annexure-IV: Employee Training Card.
Annexure-V: Training Program Report.

Manufacturing & Expiration Date, Purpose :

Manufacturing & Expiration Date, The purpose of this SOP (Standard Operating Procedure) is to provide a system for assigning of manufacturing & expiration date of products manufactured in XX Pharmaceuticals Limited.

Manufacturing & Expiration Date, Scope :

All departments of XX Pharmaceuticals Limited (Both General and Sterile Block).

Definitions/Abbreviation:

[][]BMR : Batch Manufacturing Record
[][]BPR : Batch Packaging Record
[][]LPL : XX Pharmaceuticals Limited
[][]MFG. : Manufacturing Date
[][]EXP. : Expiry Date
[][]VAT : Value Added Tax
[][]IP : Indicating Price

Responsibilities:

[][]The roles and responsibility is as follows:

Executive, Quality Assurance

[][]To ensure that this procedure is followed.

Executive, Production

[][]To follow laid down procedure.

Manager, Quality Assurance

[][]To ensure implementation of the SOP.

Head of Quality Assurance

[][]Approval of the SOP.

Annexure:

N/A

Procedure:

Assigning of Manufacturing Date
[][]Determine the manufacturing date of a batch from the month and year at which manufacturing of that batch starts (i.e. dispensing). Consider the BMR issue date as starting point of a batch. So the month and year of issuing BMR will consider as manufacturing date.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the manufacturing date.
[][]Assign the manufacturing date in block letters.
Assigning of Expiry Date
[][]Determine the expiry date from the manufacturing date and claimed shelf life of the product.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the expiration date.

[][]Those products which have no manufacturing steps except encapsulation / filling, expiry date will be declared as the manufacturer’s claimed expiry date of the active material (i.e. pellets, ready granules, different materials for injectable etc.).
[][]When the active material of two different Lab. Control No. will use in one batch, then the expiry date of the product should be considered as like shorter expiry date of API claimed by the manufacturer.
[][]Assign the expiry date in block letters.
Example: a) When claimed shelf life is 1 years.
[][]For example: Cerolab 10 Tablet
[][]If manufacturing starts (or BMR issue) at January .
[][]The manufacturing date is JAN  and expiry date is DEC of the following year
b) When claimed shelf life is 1.5 (One and half) years.
[][]For example: Cerporal PFS, 50 ml
[][]If manufacturing starts (or BMR issue) at January
[][]The manufacturing date is JAN  and the expiry date is JUN of the following year

[][]Batch number, manufacturing date, expiry date and indicating price should be printed in different packaging material as following procedure:
For inner carton (if product shelf life is 1 year)
BATCH NO. : XX0001
MFG. DATE : JAN XX
EXP. DATE : DEC XX
IP (with VAT) :

Qualification ,Purpose :

Qualification , The purpose of this SOP (Standard Operating Procedure) is to provide guidelines for carrying out the qualification at the site.

Qualification , Scope :

This SOP is applicable for qualification of all equipment, instrument, facility and utility at the site of General Block and Sterile Block of XX Pharmaceutical Ltd.

Definitions / Abbreviation:

[][]Qualification: The action of proving and documenting that equipment or utility are properly installed, work correctly, and actually produce the expected results.
[][]User Requirement Specification (URS): Documented requirement of the equipment, utility for its intended purpose. Functional design and specification according to cGMP and regulatory requirements.
[][]Design Qualification (DQ): Documented verification that the proposed design of the equipment, utility is suitable for the intended purpose.
[][]Installation Qualification (IQ): Documented verification that the equipment, utility as installed or modified, comply with the approved design, manufacturer’s recommendations and user requirement. FAT& SAT to be added.
[][]Performance Qualification (PQ): Documented verification that the equipment, utility is performing effectively and reproducibly, based on approved method and specifications.
[][]Factory Acceptance Test (FAT): Documented verification of the equipment at vendor’s site against approved design.
[][]Site Acceptable Test (SAT): Documented verification of the equipment at user site against approved design.
[][]HVAC: Heating, Ventilation & Air Conditioning
[][]LAF: Laminar Air Flow

Responsibilities:

[][]The roles and responsibility is as follows:

User department

[][]To prepare the URS of equipments, instruments, facility, utility.
[][]To prepare DQ (if required).
[][]To prepare PQ protocols

Validation Team

[][]He I She shall be responsible to carry out this procedure as defined

Engineering Department

[][]To prepare IQ, OQ protocols whenever required.
[][]To provide technical assistance to the user department for preparation of require documents.
[][]To prepare protocols for facility and utility in co- ordination with user department

Quality Assurance

[][]To review protocols and to provide technical inputs
[][]To review  reports for its completeness and correctness all data and report.

Head of Engineering

[][]He I She shall Be Responsible for Effective Implementation of this Procedure.

Head of Plant

[][]He I She shall Be Responsible for Effective Implementation of this procedure.

Head of Quality Assurance

[][]He/ She shall be responsible for effective implementation of this procedure.
[][]To approve protocols, reports and master plan.
[][]Approval of the SOP.

External agency

To provide technical assistance for preparation of documents and execution of activities whenever required

Procedure:

Methodology

[][]Facilities, Utilities and Equipment’s used for manufacturing, processing, packaging, labeling, storing, testing and controlling of drug products shall be qualified prior to use.
[][] It shall be performed for new equipment /instruments/utility/facility, after major breakdown in equipment/utility, after modification in equipment/instrument/utility and facility.
[][]Re-qualification shall be performed at define frequency.

Introduction of a new equipment/ facility/ utility:

[][]After receiving the new Equipment Engineering shall make entry in respective format and Concern
[][]department shall update the Equipment Master List as per respective of SOP.
[][]Equipment no. shall be assigned as per the SOP for Equipment and Instrument Numbering System.
[][]For new equipment following activities shall be done to demonstrate conformance to design documents, characteristics, and capabilities specified in required documents.
[][]User requirement specification (URS)
[][]Design qualification(DQ)
[][]Factory Acceptance Tests (FAT)
[][]Site Acceptance Test (SAT)
[][]Installation Qualification(IQ)
[][]Operation qualification(OQ)
[][]Performance Qualification(PQ)

User Requirement Specification:

[][]The URS is made to verify that the owner/user requirement, which includes establishment of critical operating or operational parameters or specifications before the final design agreed, has been met.
[][]User shall prepare the URS considering all operational, safety and GMP requirements.
[][]The user requirement shall be submitted to manufacturer/supplier, based on which manufacturer/supplier will prepare design.

DQ:

[][]The DQ is made to verify that the owner/user requirement, which include establishment of critical operating or operational parameters or specifications before the final design is agreed, has been met.
[][]Based on URS, manufacturer/supplier shall prepare design it documents and submit to user for approval.
[][]On the basis of approved design it documents, manufacturer /supplier shall start manufacturing/fabricating the equipment/utility.

Factory Acceptance Test:

[][]The FAT is prepared to verify that the main items or system meets design specification and conforms to agreed performance intent.
[][]User shall prepare FAT protocol according to URS/DQ, manufacturer specification and purchase order User shall ensure that the equipment/system is manufactured as per designed specification at manufacturer’s site.
[][]User also check the basic performance of the equipment/ system delivered at plant meets the design specification.
[][]User shall take photocopy of the approved FAT protocol and execute at the manufacturer’s site with QA and Engineering representative.
[][]All the test shall be performed and reported by the supplier. All tests performed during FAT must be performed in accordance with reviewed and and approved protocol and procedure.

Site Acceptance Test:

[][]The SAT is to establish documented evidence that the receipt of the item at site confirms with the standards laid down in the protocol, FAT, purchase order and manufacturer’s specification.
[][]User shall prepare SAT protocol according to the manufacturer specification, purchase order and FAT report.
[][]User shall take photocopy of the approved SAT protocol and will check the entire test mentioned in protocol with the QA & Engineering representative at the site when item I equipment I system reaches to the factory premises and reported by the production and engineer.

Installation Qualification:

[][]Installation Qualification of Equipment/utility shall be carried out is to ensure that the equipment I utility is installed according to design documents, purchase. Specifications, FAT and SAT report and planned modification.
[][]The parts of the systems, which are disassembled prior to shipping, shall be noted and be verified again after re-assembly at the final site during IQ.
[][]Equipment/utility shall be inspected either visually or by measurement for its critical parts. Wherever applicable other instruments shall be used for this purpose.
[][]All the relevant tests mentioned in protocol shall be checked after proper installation of equipment. Calibration of instrument attached with equipment and other related shall carried out before starting OQ.
[][]After completion of IQ the equipment shall be released OQ.

Operation Qualification:

[][]The Operational Qualification is carried out to verify that an Equipment/system or subsystem performs as intended throughout all anticipated operating ranges.
[][]Operation qualification activities shall start only after completion of successful IQ.
[][]QA and User representative shall use photocopy of approved protocol, which is used earlier during IQ.
[][]User department shall verify proper operation by performing the critical operating parameters that have significant impact on the equipment ability to operate and meet specifications satisfactory.
[][]User department shall prepared final conclusion after the test functions are checked and observed within specification.
[][]After completion of OQ the equipment shall be released either for PQ or for routine use as the case may be.

Performance Qualification:

[][]The performance qualification is carried out to provide documented evidence that an integrated system or processing operation is capable of performing consistently (during multiple cycles or extended periods) to give an outcome that meets predetermined specifications.
[][]PQ activities shall start only after completion of successful OQ.
[][]PQ of equipment depends upon equipment intended use and its operation.
[][]Data shall be generated to establish that the equipment meets the requirement as expected of it.
[][]A final report shall be prepared, summarizing the results obtained, commenting on any deviation observed and final conclusion shall be given after the PQ.
[][]PQ can be performed on commercial batches for new equipment. The batches shall be released only after the qualification of the equipment is completed or can be performed on placebo /dummy / trials wherever applicable.
[][]PQ shall be performed for consecutive three batches/trials with load.
[][]After completion of execution, all raw data and reports shall be compiled and a final conclusion shall be drawn.
[][]After final approval of conclusion/report by plant head and quality head the respective equipment, instrument, facility and utility shall be allowed for routine use.

Note: Operation and PQ shall be carried only if desired utility is available and environmental conditions (wherever applicable) are achieved in the area.
Qualification for introduction of a new Instrument:

[][]For new Instrument following activities shall be done to demonstrate conformance to design documents, characteristics, and capabilities specified in requirements documents.
=>Installation Qualification (IQ)
=>Operation qualification (OQ)
=>Performance Qualification (PQ)

[][]IQ : for new Instrument shall be carried out as per procedure mention above.
[][]OQ : OQ for new Instrument shall be carried out as per procedure mention above.
[][]PQ : OQ for new Instrument shall be carried out as per procedure mention above.

Protocol Preparation for FAT, SAT, IQ, OQ and PQ:

[][]The protocol for Qualification (FAT/SAT/ IQ / OQ / PQ) shall address and include, but not necessarily be limited, to the following topics.
[][]FAT: Approval, purpose, procedure, verification criteria, Manufacturer’s Machine Identification Code / Identification No., Final report approval.
[][]SAT: Approval, purpose, procedure, Documentation, Verification criteria, Final report approval.
[][]IQ/OQ/PQ: Purpose, Scope, Responsibility, Intended Use, Location, Reference, History, Attachments, Study for qualification, Responsibilities, Signature log, Training record.
[][]IQ : Equipment/Instrument Detail, Procedure, IQ table, Conclusion.
[][]OQ : SOP training, Procedure, OQ table, Observed deviation, Conclusion.
[][]PQ: Procedure, Acceptance criteria, Observed deviation, Final Conclusion Report approval sheet.
[][]Specimen of Header and Footer for above protocol is as per given below.

At the Header Section

1st Column: Company Logo
2nd Column: Company Name, Address Details
3rd Column: Doc. Title, Document No., & Location

Specimen of Footer on all Page

CONFIDENTIAL TECHNICAL DOCUMENT

[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Area Qualification:

[][]Area Qualification is carried out to provide the documentary evidences that particular area is constructed and qualified as per predefined specification.
[][]Below mentioned activities shall be performed during execution of Area Qualification, but not limited to.
[][]Construction and finishing of wall, floor, doors, view panels and ceiling.
[][]Dimension measurement wherever applicable.
[][]All the required utilities and other facilities supplied.

[][]Lighting lux of every room in all four corners and center of the room.
[][]Temperature Mapping for Classified area.
[][]Environmental condition monitoring for classified area.
[][]Water drains ability of drains.
[][]Cleaning and Sanitization Procedure.
[][]User department shall prepare the qualification protocol and organize the qualification study in co- ordination with Quality Assurance and Engineering department.
[][]Protocol/Report shall be finally reviewed by Multidisciplinary authorized personnel along with QA personnel and approved by Quality Head.

[][]Specimen of Header and Footer for above protocol is as mentioned above.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Qualification of HVAC system:

[][]HVAC qualification shall be carried out to supply the required air quality to the various section of individual department to provide product protection from air borne contamination, to maintain the temperature and humidity, to provide differential room pressure or air flow movement to provide product protection from cross – contamination.
[][]All HVAC system like AHU’s shall be qualified as per procedure described above as per approved protocols.
[][]Engineering department shall prepare the qualification protocol and organize the qualification study in co-ordination with Quality Assurance.
[][]Engineering person shall record the observations as per designed protocol and prepare a report.
[][]Below mentioned test shall be performed during qualification of AHU, but not limited to.

DOP or PAO Test
Air velocity & Air changes Test
Non viable particle count
Filter efficiency & integrity.
Particle count Test.
Microbial Count.
Air Flow Direction & Air Flow Pattern
Recovery Study
Protocol/Report shall be finally reviewed by QA and approved by Head of QA.
Specimen of Header and Footer for above protocol is as mentioned above.

[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document
numbering system.

Qualification of LAF:

[][]Qualification of LAF shall be carried out to provide the air with high-pressure compare to surrounding area and to prevent microbial and particulate matters contamination during dispensing/sampling of Raw material, prevent dusting during dispensing/Sampling.
[][]All LAF shall be qualified as per procedures described  as per approved protocol.
[][]User department shall prepared the qualification protocol and organize the qualification study in co-ordination with QA & Engineering department.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

[][]Installation Qualification: IQ of LAF shall be carried out to check LAF size as per requirement, to check pre-filter, motor blower, Magnehelic gauge and final HEPA filter as per specification.
[][]Operational Qualification: OQ of LAF shall be carried out to run the LAF and to check the operational parameter functioning.
[][]Performance Qualification: PQ of LAF shall be carried out to check LAF air velocity, Air flow pattern, air cleanliness by non viable particle count and HEPA filter efficiency & integrity, etc.
[][]User department shall record the observations as per designed protocol and prepared a report.
[][]Protocol/Report shall be finally reviewed by QA and approved by Head of QA.

Qualification of Water System:

[][]Water system qualification shall be carried out to generate Potable water & purified water of desired quality.
[][]Engineering department shall prepared the qualification protocol and organize the qualification study in co-ordination with QA.
[][]Qualification protocol shall carried following details but not limited to, IQ: Equipment/instrument details, procedure, Acceptance criteria, Pre-
qualification, Installation check, summary & conclusion.
[][]OQ: Training, Procedure, Acceptance criteria, operating inputs, summary & conclusion.
[][]PQ: Study plan, sampling Frequency, user point, summary & report.
[][]PQ of water system shall be carried out in a two phase.
[][]In phase 1, water quality parameter trend shall be evaluated on monthly basis.
[][]In phase 2, water quality parameter trend shall be evaluated after one year to evaluate impact of seasonal changes on quality of water.
[][]Engineering department shall record the observations as per designed protocol and prepared a report.
[][]Protocol/Report shall be finally reviewed by QA and approved Head of QA.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Re-qualification strategy:

[][]Equipment futility shall be re-qualified either in following conditions:
[][]Major Break Down.
[][]After modification in equipment, utility, facility which may have an impact on product quality only.
[][]Design change of spares that have impact on the performance of equipment and quality of product.
[][]In case of during Location change of equipment. (In case of balances only recalibration shall be done).
[][]As per scheduled re-qualification of critical and non equipment/utility.
[][]OQ & PQ shall be performed during requalification.
[][]PQ shall be performed with one batch during requalification.

Re-qualification criteria for critical equipment:

[][]Operational and performance qualification shall be done as per approved protocol for re-qualification of critical equipment.
[][]All critical equipments shall be re-qualified after every three years ± 1 month.
[][]During re-qualification of critical equipment/utility, only 00 and PO shall be performed. PO shall be conducted with one batch only.

[][]Re-qualification criteria for non critical equipment.
[][]Re-qualification of non critical equipment shall be conducted whether there is significant change that has influence on quality of product.
[][]For re-qualification of non-critical equipment, history of maintenance and utilization of the equipment shall be reviewed and documented as per format of Re qualification of non-critical Equipments (Attachment 1).
[][]All non – critical equipments shall be re-qualified after every three years ± 6 months.

Re-qualification criteria for Instrument in following conditions:

[][]When the instrument is shifted from one laboratory (Change in premises) to another laboratory, re qualification (10, 00 and PO) is required.
[][]When the instrument is upgraded or after having a major repairing, qualification (OO/PO) is required.
[][]When the instrument is shifted within the laboratory premises (one room to another room), re qualification is not required, in house calibration is required.

Re-qualification criteria for HVAC System:

[][]Re qualification of HVAC(AHU) shall be carried out in below mention criteria, but not limited to Change in a location of the equipment/system.
[][]Major change in equipment, Change of spare/ parts that have a direct bearing on the Performance of the equipment.
[][]Schedule Re-Qualification.
[][]Frequency of Re-qualification of AHU shall be One Year.± One month. Below mentioned test shall be carried out at defined frequency.

Parameter/Frequency

=>Air Velocity /Initially and Once in year
=>Air Changes /Initially and Once in year
=>Filter Integrity Test /Initially and Once in year
=>Particle Count /Initially and Once in year
=>Microbial Count /Initially and Once in year
=>Air Flow Direction /Initially and Once in year
=>Air Flow Pattern /Initially and Once in year
=>Recovery Study /Initially and Once in year

Re-qualification criteria for LAF:

[][]Re qualification of LAF shall be carried out in below mention criteria, but not limited to.
[][]Change in a location of the equipment/system.
[][]Major change in equipment, Change of spare/ parts that have a direct bearing on the Performance of the equipment.
[][]Critical gauges shall be replaced or corrected if the gauge is found out of calibration during calibration of the gauges.
[][]Schedule Re qualification.
[][]Frequency of Re-Qualification of LAF shall One Year.± One month.

Re-qualification criteria for utilities:

[][]Re-qualification shall be carried out to ensure that change I modification in utilities remain under
[][]Control and within the parameters defined and certified.
[][]Re qualification of utilities shall be carried out in below mention criteria, but not limited to.
[][]Change in location

[][]Any modification that has a potential to impact the product quality.
[][]Scheduled re-qualification after every 3 years.

Re-Qualification of Compressed Air:

[][]Re qualification of Compressed Air shall be carried out in below mention criteria, but not limited to,
[][]In case of any modification which has impact on product quality.
[][]Scheduled re-qualification after everyone year.

Annexure:

Annexure-I: Requalification of non-critical Equipment’s