Calibration for Weighing Balances In various industries, such as pharmaceuticals, laboratories, manufacturing, and research, precise measurements are of utmost importance. Weighing balances are essential instruments that enable us to obtain accurate measurements, making them crucial in ensuring the quality of products, integrity of research, and compliance with regulatory standards. Calibration …
Read More »Calibration procedure for halogen moisture analyzer
Calibration procedure for halogen moisture analyzer OBJECTIVE To lay down the procedure for calibration of the Halogen moisture analyzer, SCOPE This SOP shall provide the calibration procedure of the Halogen moisture analyzer in the in-process quality assurance department and quality control department. RESPONSIBILITY Officer/ Executive – Quality Control/Quality Assurance. ACCOUNTABILITY …
Read More »Handling of Returned Pharmaceutical Products
Handling of Returned Pharmaceutical Products OBJECTIVE : To establish a procedure for the Inspection and Handling of Returned Drug Products. RESPONSIBILITY : Head – Warehouse to inform Head QA about the product returned. Officer Warehouse to identify the product returned, against documents received and to verify the physical conditions of …
Read More »SOP for calibration of disintegration test apparatus
SOP For calibration of disintegration test apparatus OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus. SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus . RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Check the water level in the water …
Read More »SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO)
SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO) OBJECTIVE To lay down the procedure for Calibration of Autotitrator (METTLER TOLEDO DL50). SCOPE This SOP shall be applicable for the Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply …
Read More »Procedure for calibration of calculator
Procedure for calibration of the calculator OBJECTIVE To lay down the Procedure for Calibration of the calculator. SCOPE This SOP provides guidance to calibrate the calculators, which are used for simple and complex calculations of analysis in the quality control department. Scientific calculator Desktop calculator Calculator used in the computer …
Read More »Change Control Review SOP
Change Control Review SOP Change Control Review is the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs), This procedure is applicable for review and changes control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the …
Read More »SOP For Calibration procedure for pH meter
SOP For Calibration procedure for pH meter OBJECTIVE To describe the calibration procedure for pH meter. SCOPE This SOP shall be applicable for the calibration procedure for pH meter RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager PROCEDURE Operate the Instrument as per procedure. Insert the pH electrode and temperature …
Read More »Change Control in Pharma Industries
Change Control in Pharma Industries Change Control in Pharma Industries is a procedure to ensure that no changes are made in any approved pharmaceutical product, manufacturing process, GMP-related equipment/facility/utility, computer system, Standard Operating Procedures (SOPs), Standard Cleaning Procedures (SCPs), Master Production Records, specifications, standard test procedures, the vendor of raw …
Read More »HANDLING OF MARKET COMPLAINTS
HANDLING OF MARKET COMPLAINTS To provide the procedure for handling of market complaints and to ensure that all complaints related to drug products are recorded and investigated promptly with the aim of addressing them in a timely manner to satisfy the complainant, adhere to compliance requirements as well as to …
Read More »SOP For Control of Completed Batch Production
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 …
Read More »Review of Batch Production Records
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 …
Read More »SOP For Release of Finished Products
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 …
Read More »SOP For Process Area clearance during batch/product changeover
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 …
Read More »SOP For Assigning of repacking before date
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 …
Read More »SOP on Cleaning of Sampling Aids
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 …
Read More »SOP on Annual Product Review of Drug Product Quality (APQR)
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 …
Read More »SOP on Cleaning Validation in pharmaceutical company
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 …
Read More »Reporting, Investigating and Disposition of Incidents
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 …
Read More »Packaging Area/Line Clearance during batch/product change over
OBJECTIVE : To outline the procedure for the Packaging Area/Line clearance before the start up of any packaging operation, to ensure that the packaging area/line has been thoroughly cleaned and that all coded labeling and packaging materials of the previous batch/product have been completely removed. RESPONSIBILITY : Officer – Production …
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