QA & QC

SOP For Control of Completed Batch Production OBJECTIVE : To provide a procedure for the proper control of completed Batch Production Records (BPR) after the release of finished drug products for distribution. RESPONSIBILITY : Officer – Quality Assurance. Officer – Documentation. Head of Quality Assurance Department to ensure compliance. PROCEDURE …

Review of Batch Production Records OBJECTIVE : To provide a procedure for the review of the Batch production records (BPR) before releasing drug products, in order to verify compliance with cGMP requirements and all established specifications and written procedures in the manufacturing of the product batch. RESPONSIBILITY :  Quality Assurance …

SOP For Release of Finished Products OBJECTIVE : To lay down the procedure for QA release of Finished Product for distribution. RESPONSIBILITY : Quality Assurance Officer. Head of Quality Assurance Department to ensure compliance. PROCEDURE : After receiving Finished Product Release Report (FRR)  (Annexure – 1) from Production Department, QA …

SOP For Process Area clearance during batch/product changeover OBJECTIVE : To provide a procedure for  Process area clearance during batch/product changeover. RESPONSIBILITY : Officer Quality Assurance for implementation Head of Quality Assurance Department to ensure compliance. PROCEDURE : Note: Type-A  Area clearance : During the batch changeover of the same …

SOP For Assigning repacking before the date OBJECTIVE : To lay down the procedure for assigning ‘repack before date’. RESPONSIBILITY : Officer  Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE The ‘repack before date’ shall be assigned from the day packing is initiated. The basis for a …

SOP on Cleaning of Sampling Aids OBJECTIVE : To lay down a procedure for cleaning Sampling Aids. RESPONSIBILITY : Officer – Quality Quality Assurance to implement the procedure. Head – Quality Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA 02 Neutral, solution). To about …

SOP on Annual Product Review of Drug Product Quality (APQR) OBJECTIVE : To establish a procedure for the preparation, review, and approval of Annual product reviews to assure the consistent and acceptable quality of each product manufactured for distribution and apprise upper management of any changes needed. RESPONSIBILITY : Officer …

SOP on Cleaning Validation in a pharmaceutical company OBJECTIVE : To establish and explain the procedure to be followed for the cleaning Validation of Standard Cleaning Procedures (SCP)s, in order to  Assure that the fitness of the equipment is adequately protected for every product.  Demonstrate that no cross-contamination will be …

Reporting, Investigating, and Disposition of Incidents OBJECTIVE : To lay down a procedure for reporting, investigating, and disposition incidents in the Quality Assurance Department. RESPONSIBILITY : Officer-QA to raise Incident Report to allot number & due date to the Incident Report. Officer-QA & Head-QA or his designee to investigate and …

Cleaning of Unit Dose and Large Volume Sampling Thieves OBJECTIVE : To lay down the procedure for cleaning unit dose and large volume sampling thieves. RESPONSIBILITY : Executive -Quality Assurance to implement the procedure. Head – Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA …