Responsibilities of the 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.
The Quality Assurance department shall be responsible for the sampling of raw / packing materials, in-process materials, finished products, and stability samples.
The Quality Assurance department shall be responsible to review and approve validation protocols, to review changes in product processes, equipment, or any other changes as per SOP “Change Control program”.
The Quality Assurance department shall be responsible to check dispensing of materials and for in-process quality control.
The 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, recorded and authorized.
The Quality Assurance department shall be responsible for auditing methods, results, systems, and processes and for performing the trend analysis and preparation of an annual review of drug product quality.
The Quality Assurance department shall be responsible to release the finished products and to maintain the reserve samples of finished products and batch production and control records.
The Quality Assurance department shall be responsible to investigate market complaints and to maintain market complaints investigation records.
The Quality Assurance department shall be responsible for the issue, control, review, and retrieval of worksheets.
The Quality Assurance department shall be responsible for the disposition of Incidents/OOS and approval of deviations.
The Quality Assurance department shall be responsible for the monitoring of stability studies.
Quality Assurance personnel shall be trained as per the SOP “Training and Evaluation of Quality Assurance Officers”.
Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
