Responsibilities of Quality Assurance Department
OBJECTIVE:
To lay down the responsibilities of the Quality Assurance Department.
RESPONSIBILITY :
All personnel of the Quality Assurance Department.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE :
The Quality Assurance department shall be responsible to formulate systems for the implementation of cGMP and, to ensure the preparation, approval, and implementation of Standard Operating Procedures, Standard Cleaning Procedures, Specifications, Standard Test Procedures, Cleaning validation protocols, stability protocols, Master Batch Production records, etc.,
The Quality Assurance department shall be responsible for the evaluation and qualification of vendors of raw materials and packaging materials.
Quality Assurance department shall be responsible for a sampling of raw / packing materials, in-process materials, finished products and stability samples.
Quality Assurance department shall be responsible to review and approve validation protocols, to review changes in product processes, equipments ,or any other changes as per SOP “Change Control programme”.
Quality Assurance department shall be responsible to check dispensing of materials and for in-process quality control.
Quality Assurance department shall be responsible to release the batch after reviewing the Batch Production records to assure that the batch has been manufactured as per the Master Batch Production Record and there are no deviations and deviations, if any, are recorded and authorized.
Quality Assurance department shall be responsible for auditing methods, results, systems and processes and for performing the trend analysis and preparation of annual review of drug product quality.
Quality Assurance department shall be responsible to release the finished products and to maintain the reserve samples of finished product and batch production and control records.
Quality Assurance department shall be responsible to investigate market complaints and to maintain market complaints investigation records.
Quality Assurance department shall be responsible for issue, control, review and retrieval of worksheets.
Quality Assurance department shall be responsible for disposition of Incidents/OOS and approval of deviations.
Quality Assurance department shall be responsible for monitoring of stability studies.
Quality Assurance personnel shall be trained as per the SOP “Training and Evaluation of Quality Assurance Officers”.
Forms and Records
NA
Distribution
- Master Copy – Documentation Cell (Quality Assurance)
- Controlled Copies – Quality Control, Production, Stores, Engineering
History
- Revision Number
- Reason for Revision
