Standard Operating Procedure of Performance Qualification (PQ) in pharmaceuticals is describe in this post.
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1. PURPOSE
This SOP describes a procedure to,
1.1 Determine that the Instrument / Equipment / System performs as intended.
1.2 Record all relevant information and data to demonstrate that performance consistently meets pre-determined specifications under normal conditions and where appropriate for worst case situations.
2. SCOPE
Performance Qualification is performed after Installation and Operational Qualifications, Modification, re-location, out spec. results and for re-qualification of any Instrument / Equipment / System present in Production, Warehouse (RM/PM, FG), Q.C and Maintenance departments.
3. RESPONSIBILITY
3.1 Qualification Team comprises of concerned Section Officer, Head of Department, Maintenance department (where required), Executive Q.A Validation and Q.A Manager.
3.2 Section Officer assigned by HOD performs the qualification and records the information.
3.3 Head of Deptt. supervises the study, verifies the completion of the records.
3.4 Section Officer writes the Deviation Report and Head of Deptt. verifies it.
3.5 Head of Deptt. and Section Officer fill the PQ Protocol and write PQ Report.
3.6 The Maintenance department (where required) help the Deptt. (User) in Performance Qualification.
3.7 Executive Q.A Validation assists the concerned Deptt. in Performance Qualification study and reviews the Performance Qualification Protocol and PQ Report.
3.8 Q.A Manager approves the Performance Qualification Protocol and Performance Qualification Report.
4. MATERIAL & EQUIPMENT
4.1 Instrument/ Equipment/ System to be Qualified.
5. PROCEDURE
5.2 Equipment / Instrument is run under normal operating procedure three times and all required data is recorded and any deviation to the procedure is also recorded.
5.3 System is run for 20 consecutive working days and recorded all required data and any deviations to the procedure(s) (e.g. Purified Water System).
5.4 Performance Qualification Study have two portions,
5.4.1 PORTION-1
a. This portion is of Protocol (page # 1-3) and is completed (before start of PQ study) by Section Officer, HOD and Maintenance department (where required), reviewed by Executive Q.A Validation and sent to Q.A deptt. for approval by Q.A Manager.
5.4.2 PORTION-2
a. This portion is of Report (page # 4-7) and is completed during the PQ study.
5.5 Head of Deptt. / Section Officer supervises the study and verifies the completion of the records.
5.6 Section Officer and HOD with the consultation of qualification team, fill the protocol (pages 1-3) of Performance Qualification Protocol and send these pages to Q.A deptt. for approval.
5.7 Executive Q.A Validation gets its approval from Q.A Manager, after thorough review.
5.8 Q.A assigns Performance Qualification (PQ) # to Instrument / Equipment / System from the Equipment Qualification Log Book and sends theses pages back to section for performance; Serial # of PQ # is same as its Serial # in OQ #.
5.9 Section Officer / Officer assigned by HOD perform the qualification and record the information.
5.10 Tests to be performed are decided by Qualification Team (e.g. for Purified Water along with Water for Injection validation tests are performed as per specifications of Purified/ Water for Injection to show that the water quality meets the specifications.
5.11 Objective and scope of performing Performance Qualification Activity and responsible persons for performing this activity are noted on Page 1 of Performance Qualification Protocol
5.12 Tests to be performed on each Instrument / Equipment / System, should be described in any document (may be manual or any procedure) with acceptance criteria, which can be increased if required by qualification team according to requirements. These Tests are descried on Page 2 of Performance Qualification Protocol.
5.13 Sampling plan for the performance and Utility / Service required for test(s) is noted on Page 3 of Performance Qualification Protocol. This page is prepared by Section Head / HOD with the consultation of qualification team and these pages (Protocol) are sent to Q.A deptt. for approval.
5.14 Information about test(s), their description, acceptance criteria and results obtained during performance are recorded on Page 4 of Performance Qualification Report.
5.15 For Equipments, run normal operational procedure three times and record all the required data.
5.16 For System, run normal operational procedure for 20 consecutive working days and record all required data.
5.17 All required calculations and statistical analysis are performed on Page 5 of Performance Qualification Report (perform any calculation regarding test, if required).
5.18 Deviation Report is prepared including the justification of acceptance and impact of deviation(s) on the performance on Page 6 of Performance Qualification Report.
5.19 Section Officer writes the Deviation Report.
5.20 Performance Qualification Report is prepared on Page 7 of Performance Qualification Report that includes,
5.23.1 Date study initiated and date study completed,
5.23.2 Problems encountered,
5.23.3 Summary of deviation report,
5.23.4 Results (briefly describe whether or nor they meet specifications),
5.23.5 Location of original data,
5.23.6 Conclusion (includes that Instrument/Equipment/System performs according to specifications and Performance Qualification is completed),
5.23.7 Periodic Re-qualification date.
5.24 After PQ completion, whole Report is submitted to QA for review and approval.
5.25 After Q.A Manager approval of Performance Qualification Documents, PQ document approval date and relevant informations are entered in the Equipment Qualification Log Book by Executive Q.A Validation.
5.26 This Performance Qualification Protocol and Report along with relevant documents is placed in the Instrument / Equipment / System file of respective department in Q.A.
5.27 After Successful completion of Performance Qualification a Label “Equipment Qualification” is filled at this stage by person performing the qualification and pasted on that Instrument / Equipment / System.
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