Responsibilities of Quality Assurance Department
1.0 OBJECTIVE:
To lay down the responsibilities of Quality Assurance Department.
2.0 SCOPE:
The scope of this Standard Operating Procedure (SOP) is to provide the responsibility of Quality Assurance Department.
3.0 RESPONSIBILITY:
3.1 All personnel of Quality Assurance Department
3.2 Head of Quality Assurance Department to ensure compliance
4.0 PROCEDURE:
4.1 Responsibilities and procedure applicable to Quality Assurance department shall be in writing and same shall be followed. Responsibilities of the Quality Assurance Department shall be as under:
4.1.1 Approving or rejecting all components, Drug product container and closure, in process materials, packaging material, labeling and Drug product based on the review of record of Analysis.
4.1.2 Review of production record / Record of Analysis to assess that no errors have occurred. This includes review of documents like,
4.1.2.1 Master production control record i.e Batch Manufacturing Record and Batch Packaging Record.
4.1.2.2 Standard Operating Procedure (SOP)
4.1.2.3 Process validation Protocol/Reports, and others
4.1.2.4 Review of Analytical records
4.1.3 Management of Deviation and Incidents.
4.1.4 Review changes in Product Process, Equipment, System, or any other changes impacting manufacturing or Analytical methods as per SOP on “Change Control Programme”.
4.1.5 Ensure the preparation, approval and implementation of Standard Operating Procedures (SOP), validation protocols and reports, stability protocols and reports, Batch Manufacturing Records and Batch Packaging Records etc.
4.1.6 Carryout periodic Internal Quality Audits to ensure adherence to the written down procedure and cGMP compliance as per SOP. Also auditing the External Contract Laboratory for verifying their compliance to Good Laboratory Practices.
4.1.7 To ensure that all personnel have undergone training as per the requirements mentioned in individual SOP for training.
4.1.8 Preparation, review and approval of Annual Product Quality Review and to recommend any needed changes in control method, Manufacturing Process, Specification, etc.
4.1.9 Preparation of Management Review Report at a desired frequency for communicating the status of various activities with senior management.
4.1.10 Release of the Finished Product after reviewing and verifying the relevant data’s and documents.
4.1.11 Investigate Market complaints, maintaining Investigation records and further taking and planning proper Corrective Action and Preventive Action (CAPA).
4.1.12 Sampling of In process material, Finished products samples, Stability samples and Validation samples as per sampling plan.
4.1.13 Monitoring the Dispensing Activity.
4.1.14 Environment Monitoring and carrying out in process checks during Manufacturing and Packaging process.
4.1.15 Handling online rejection during production activity.
4.1.16 Receiving and maintaining the details regarding the Vendors for various components.
4.1.17 Collection, Storage and Annual Checks and Disposal of Control samples (Reserve Samples).
4.1.18 Disposition of Incidents/OOS (Out of Specification) and approval of deviations with proper CAPA.
4.1.19 Monitoring of stability studies.
4.1.20 Issuance, control, review and retrieval of all controlled Logbooks / registers, records, SOP, SCP, STP, etc.
4.1.21 Ensuring of validation and qualification activity.
4.1.22 Maintaining liaisons with local FDA.
4.1.23 Preparation and review of technical documents like Validation Master Plan and Site Master File.
4.1.24 Ensuring effective implementation of work permit or modification in the facility and equipment.
4.2 Responsibility of Corporate Quality Assurance:
4.2.1 Approving or rejecting all procedures or specification impacting on the identity, Strength, Quality, and Purity of the Drug product.
4.2.2 Preparation of Technical Analytical Documents
4.2.3 Coordinate and give technical guidance for Handling Market Complaint and Product Recall.
4.2.4 Vendor Approval and rejection based on the vendor audit.
4.2.5 Preparation of Corporate Quality Guidelines (GLP/ GMP manuals) used as reference.
4.2.6 Conducting audits of locations for Verifying cGMP Compliance.
5.0 ANNEXURE:
Not applicable