Standard Operating Procedure of Operational Qualification (OQ) in Pharmaceuticals is describe in this post.
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1. PURPOSE
This SOP describes a procedure to,
Determine that the installed Equipment / Instrument / System operates according to specifications, record all relevant information’s, deviations and data to demonstrate that it operates within expected parameters.
2. SCOPE
Operational Qualification is performed after Installation Qualification, Modification, re-location, out of spec. results and for re-qualification of the any Instrument / Equipment / System present in Production, Warehouse (RM/PM, FG), Q.C and Maintenance departments.
3. RESPONSIBILITY
3.1 If vendor performs the Operational Qualification then vendor may record the data on his own forms.
3.2 Head of Deptt. and Section Officer verify the vendor qualification and record.
3.3 Q.A Manager approves this Qualification and record.
3.4 Qualification Team comprises of concerned Section Officer, Head of Department, Maintenance department (where required), Executive Q.A Validation and Q.A Manager.
3.5 If Operational Qualification is carried out by Deptt. / Section itself, then Section Officer or officer assigned by Head of Department performs the qualification and records the information.
3.6 Head of Deptt., Section Officer, supervises the study, verify the completion of the records.
3.7 Section Officer writes the Deviation Report and Head of Deptt. verifies it.
3.8 Head of Deptt. and Section Officer fill the OQ Protocol and write OQ Report.
3.9 The Maintenance Incharge (s) (if required) help the Deptt. (User) in Operational Qualification.
3.10 Executive Q.A Validation assists the concerned Deptt. in Operational Qualification study and reviews the Operational Qualification Protocol and OQ Report.
3.11 Q.A Manager approves the Operational Qualification Protocol and Operational Qualification Report.
4. MATERIAL & EQUIPMENT
4.1 Instrument/ Equipment/ System to be Qualified.
4.2 Equipment Qualification Label
5. PROCEDURE
5.1 Operational Qualification Study have two portions,
5.1.1 PORTION-1
a. This portion is of Protocol (page # 1-4) and is completed (before start of OQ study) by Section Officer, HOD and Maintenance department (where required), reviewed by Executive Q.A Validation and approved by Q.A Manager.
5.1.2 PORTION-2
a. This portion is of Report (page # 5-10) and is completed during the OQ study.
5.2 Section Officer and HOD with the consultation of qualification team, fill the protocol (pages 1-4) of Operational Qualification Protocol and send these pages to Q.A deptt. for approval.
5.3 Executive Q.A Validation gets its approval from Q.A Manager, after thorough review and sends these pages back to section for performance.
5.4 Q.A assigns Operational Qualification (OQ) # to Instrument / Equipment / System from the Equipment Qualification Log Book and sends these pages back to section for performance; Serial # of OQ # is same as its Serial # in IQ #.
5.5 Objective and scope of performing Operational Qualification Activity and responsible persons for performing this activity are noted on Page 1 of Operational Qualification Protocol.
5.6 Control points and alarms (noted from manual) along with their acceptance criteria are noted down on Page 2 of Operational Qualification Protocol.
5.7 Operational Functions (output) with their acceptance criteria are noted on Page 3 of Operational Qualification Protocol.
5.8 Specific challenge of the Instrument / Equipment / System in worst case situation (taken from the manual e.g. upper and lower limit of operation etc.) along with their acceptance criteria are noted on Page 4 of Operational Qualification Protocol.
5.9 Specific challenge to the Instrument / Equipment / System is decided by Qualification Team.
5.10 Control points and alarms (noted from manual), their acceptance criteria and results obtained during performance are recorded on Page 5 of Operational Qualification Report.
5.11 Operational Functions (output), their acceptance criteria and results obtained during performance are recorded on Page 6 of Operational Qualification Report.
5.12 Where appropriate, specific challenge to the Instrument / Equipment / System in worst case situation (taken from the manual e.g. upper and lower limit of operation etc.) is measured and results are recorded on Page 7of Operational Qualification Protocol.
5.13 If Manual is not available (in case of old instrument) then all control points, alarms and operational functions are decided by qualification team.
5.14 Record of personnel trained is maintained on Page 8 of Operational Qualification Report.
5.15 Deviations to the procedures are recorded.
5.16 Deviation Report is prepared including the justification of acceptance and impact of deviation(s) on the operation on Page 9 of Operational Qualification Report.
5.17 Operational Qualification Report is prepared on Page 10 of Operational Qualification Report which includes,
5.17.1 Date study initiated and date study completed,
5.17.2 Brief description of deviations, their reasons and impact,
5.17.3 Problems Encountered (if any during operation),
5.17.4 Results (Brief explanation of results, whether they comply specifications or not),
5.17.5 Location of relevant informations and documents,
5.17.6 Conclusions (includes that Instrument / Equipment / System operates according to specifications and Operational Qualification is completed).
5.17.7 Periodic Re-qualification date if PQ not required as decided by validation team.
5.18 After OQ completion, whole Report is submitted to Q.A for review and approval.
5.19 After Q.A Manager approval of Operational Qualification Documents, OQ document approval date and relevant informations are entered in the Equipment Qualification Log Book by Executive Q.A Validation.
5.20 This Operational Qualification Protocol and report along with relevant documents is placed in the Instrument / Equipment / System file of that department in Q.A.
5.21 After Successful completion of Operational Qualification a Label “Equipment Qualification” is filled by Executive Q.A Validation and pasted on that Instrument / Equipment / System by person performing the qualification.
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