RESPONSIBILITIES OF THE QUALITY ASSURANCE DEPARTMENT
OBJECTIVE: To lay down the responsibilities of the Quality Assurance Department.
SCOPE: The scope of this document is to provide the responsibilities of QA .
RESPONSIBILITY: QA Personnel: To perform as per procedure.
ACCOUNTABILITY: Head – QA.
PROCEDURE:
Responsibilities and procedure applicable to QA shall be in writing and same shall be followed. Responsibilities of the QA shall be as under.
To ensure a personnel have undergone training as per the requirement mentioned in individual SOP.
Ensure the preparation, approval and implementation of SOP, validation protocol and report stability protocols and report, BMR and BPR etc.
Issuance, control review and retrieval of all controlled logbook/format, records, SOP, specification, worksheet, protocol.
Ensuring of validation and qualification activity.
Preparation and review of technical document like validation master plan and site master file.
Receiving and maintaining the details related to vendors for various components.
Approving or rejecting all drug product component, drug product container and closure, in-process material, packaging material, labelling and drug product based on the review of record of analysis.
Monitoring the dispensing activity.
Environment monitoring and carrying out in process check during manufacturing and packaging activity.
Sampling of in process material, validation sample finished product, stability sample as per sampling plan.
Handling online rejection during manufacturing and packaging activity.
Review of batch manufacturing record and batch packaging record/record of analysis to assess that no errors have been occurred. This includes review of documents like,
Master Formula Record (MFR), BMR and BPR.
Standard Operating Procedure.
Process Validation Protocol/Report and Others.
Review and Analytical Records.
Release of the finished product after reviewing and verifying the relevant data and
Management of deviation and incidents.
Review approved change in product process, equipment system or any other changes impacting manufacturing or analytical method as per SOP on procedure for handling of change control proposal.
Collection, storage and annual checks and disposal of control sample.
Disposition of incident / OOS (Out of Specification) and approval of deviation with proper CAPA.
Monitoring of stability studies.
Ensuring effective implementation of work permit or modification in the facility and equipment.
Ensuring effective implementation of calibration and preventive maintenance in the facility and equipment.
Carryout periodic self inspection (internal audit) to ensure adherence to the written own procedure and CGMP compliance as per SOP. Also auditing to external contract laboratory for verifying their compliance to good laboratory practices.
Preparation, review and approval of Product Quality Review (PQR) and to recommend any needed change in control method of manufacturing process and / or specification, etc.
Preparation of management review report at a desired frequency for communicating the status of various activities with senior management.
Investigate market complaint, maintaining investigation record and further taking and planning proper Corrective Action and Preventive Action (CAPA).
Maintaining with local FDA.
Imparting technical training to plant personnel.
Periodic review of logbook for quality critical parameters such as process areas, quarantines, stores, lab area and primary packaging as per annex-1.
Signature to be done (along with name and department) on executed logbook during review by Quality Assurance.
QA shall review the logbook for completeness and correction as per good documentation practice and cGMP norm.
QA shall prepare the quarterly and yearly trend of purified water system.
Support regulatory submission.
Review of document by Data Integrity Review (DIR) section.
To conduct online audit as per self inspection SOP.
To notify management telephonically mail.
QA shall facilitate quality agreement with customers and contract laboratories.
To coordinate and arrange meeting for local technical committee.
ENCLOSURE: Log book Review Frequency
