Standard Operating Procedure for Role and Responsibilities of QA personnel in Pharmaceuticals
1.0 Purpose:
This SOP gives the responsibilities and authorities of Quality Assurance personnel.
2.0 Scope:
This SOP is applicable for QA Department at [Company name].
3.0 Responsibility:
Head Quality – Overall Responsibility of Compliance
4.0 Definitions:
Not applicable.
5.0 Procedure:
• Organogram of department
Corporate QA Head < Head of Quality < Head of QA < Section Heads < Respective section Team Members
• Responsibilities and authorities of Corporate QA Head
1. Reporting to Chief Operating Officer
2. Approval of master formulae.
3. Approval of standard analytical procedure of Semi-finished and finished product.
4. Approval of standard analytical procedure for raw materials.
5. Approval of standard analytical procedure for packaging materials.
6. Approval of Validation Master plan and validation procedures.
7. Approval of departmental standard operating procedures of QA, QC, Manufacturing, Packaging, Stores, Maintenance and Administration department.
8. Approval of customer complaint investigation report.
9. Approval of destruction/disposal.
10. Recruitment of personnel in Quality Control and Quality Assurance.
11. Arrange cGMP training for employees.
12. Review of capital equipment requirements of QC, QA and approval of purchase orders.
13. Approval of Annual Product Quality Review.
14. Review of action plans in response to audits of manufacturing facility by external agencies.
15. Review and Approval of ‘out of specification’ investigation.
16. Approval of deviation.
17. Approval for change control.
18. Approval for product recall.
• Responsibilities and authorities of Quality Head
1. Controlling and Monitoring the critical activities of Quality Control and Quality Assurance Department.
2. Review of master formulae.
3. Review of Site Master File, Validation Master plan and validation procedures.
4. Release or rejection of raw material, packaging material, Semi-finished and finished product.
5. To conduct training programme with respect to cGMP and its implementation.
6. Checking of standard operating procedures of QA, QC, Manufacturing, Packaging, Stores, and Maintenance and Administration department.
7. Approval of Batch Manufacturing record and Batch Packaging Record.
8. Review of customer complaint investigation as well as necessary preventive action.
9. Carry self-audit and Review the compliance.
10. Review of destruction/disposal of Material.
11. Recruitment of personnel in Quality Control and Quality Assurance.
12. On job training for Quality control and Quality Assurance personnel.
13. Review of ‘out of specification’ results.
14. Handling of external audits and co-ordination of compliance response to regulatory observations.
15. Review the change control and implement the approved change control.
16 To conduct vendor audits.
17. Verification of batch manufacturing records
19. Review of deviations.
20. Review of Annual Product Quality Review and necessary corrective action.
21. Approval for In- house Trainers
22. Approval of Stability study record
23. Verification and evaluation of qualification.
• Responsibilities and authorities of Head QA
1. Controlling and Monitoring the critical activities of Quality Control and Quality Assurance Department.
2. Review of master formulae.
3. Preparation of Site Master File, Validation Master plan and validation procedures.
4. Release or rejection of raw material, packaging material, Semi-finished and finished product.
5. Coordinate to Establish training programme with respect to cGMP.
6. Checking of standard operating procedures of QA, QC, Manufacturing, Packaging, Stores, and Maintenance and Administration department.
7. Approval of Batch Manufacturing record and Batch Packaging Record.
8. Carry self-audit and Review the compliance.
9. Review of customer complaint investigation as well as necessary preventive action.
10. Review of destruction/disposal of Material.
11. Co-ordinate for the Recruitment of personnel in Quality Control and Quality Assurance.
12. On job training for Quality control and Quality Assurance personnel.
13. Handling of external audits and co-ordination of compliance response to regulatory observations.
14. Review of ‘out of specification’ results.
15. Review the change control and implement the approved change control.
16. To conduct vendor audits.
17. Verification of batch manufacturing records
18. Review of deviations.
19. Review of Annual Product Quality Review and necessary corrective action.
20. Co-ordination of Validation activity and review of Validation documents
• Responsibilities and authorities of Section Head
1. Co-ordinate in monitoring and Controlling the critical activities of Quality Assurance.
2. Preparation of Master formula Record, Batch Manufacturing Record and Batch packing Record.
3. Co-ordinate in the Release or rejection of raw material, packaging material, Semi-finished and finished product.
4. To check on-line maintenance of Documents.
5. Involved in the preparation of Specification
6. To check Standard operating procedure compliance and execution. Issuance and Preparation of SOP.
7. To aid in the investigation of customer complaint as well as implementation of the suggested preventive actions.
8. Co-ordination in the activities related to self-audit and external audit compliance.
9. Handling of destruction and Disposal.
10. Identifying, handling and execution of Change control, Deviation, Notification and Incidence
11. Review of Annual Product Quality Review and necessary corrective actions.
12. Co-ordination of Validation activity and review of Validation Protocols.
13. Involvement in the scale up activities and preparation of the related documents.
• Responsibilities and authorities of Executive QA
1. Partake in controlling, implementing, Executing the activities of Quality Assurance. To establish and maintain a satisfactory system of Quality Assurance at shop floor.
2. Preparation of Master formula Record, Batch Manufacturing Record and Batch packing Record.
3. Co-ordinate in the Release or rejection of raw material, packaging material, Semi-finished and finished product.
4. To check on-line maintenance of Documents.
5. To check Standard operating procedure compliance and execution.
6. Issuance, Retrieval, Destruction of Documents.
7. Handling of destruction and Disposal.
8. To aid in the investigation of customer complaint as well as implementation of the suggested preventive actions.
9. Co-ordination in the activities related to self-audit and external audit compliance
10. Identifying, handling and execution of Change control , Deviation, Notification and Incidence
11. Review and Destruction of Control Sample
12. Review of Annual Product Quality Review and necessary corrective actions.
13. Monitoring and executing the Validation activities.
14. Involvement in the scale up activities and preparation of the related documents.
15. Involved in the storage and Control of Quality Assurance documents.
16. Involvement in the execution of training and Development programme with respect to cGMP.
17. Preparation and distribution of Standard Operating Procedure
18. To carry out Line clearance checks and In-process checks.
19. To carry out sampling for commercial as well as validation batches with respect to the related documents like protocols etc.
20. To carry out sample management and check on-line maintenance of documents
• Responsibilities and authorities Officer QA
1. Issuance, Retrieval and destruction of Documents
2. Preparation, Compilation and Execution of Validation Protocol and of Validation data.
3. Involved in the storage and Control of Quality Assurance documents.
4. Preparation and distribution of Standard Operating Procedure.
5. Identifying, handling and execution of Change control, Deviation, Notification and Incidence.
6. To check the compliance and execution of Standard operating procedure of Quality Assurance.
7. Co-ordination and execution of validation activities and procedures.
8. To carry out sampling for commercial as well as validation batches with respect to the related documents like protocols etc.
9. To identifying the requirement of Documentation and key stages in the validation process.
10. To establish and maintain a satisfactory system of Quality Assurance at shop floor.
11. Involvement and Execution in the scale up activities and preparation of the related documents.
12. To carry out Line clearance checks and In-process checks.
13. To Carry out on-line review of the Batch Records and other related documents.
14. Preparation of Annual product Quality Review.
15. Cleanliness, Environment monitoring and Control at the start and during every process in the production area (manufacturing and Packing)
16. Maintenance of documentation cell.
17. Verification of online rejection and destruction if any.
18. To carry out sample management and check on-line maintenance of documents.
19. Monitoring, inspection and destruction of Control sample.
6.0 Frequency
• As and when required.
7.0 Formats
Not applicable
