Pharma Editor

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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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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Cleaning of Unit Dose and Large Volume Sampling Thieves

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 …

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Responsibilities of Quality Assurance Department

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 …

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Procedure for calibration of HPLC (WATERS ALLIANCES)

Procedure for calibration of HPLC (WATERS ALLIANCES) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. As …

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Procedure for operation of IR Spectrophotometer (SHIMADZU)

OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY  Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF …

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Collection, Storage and Control of Reserve Samples for Drug Products

Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of  Quality Assurance Department to ensure …

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Correction of Documentation Errors

OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during  documenting  data  in  operating  departments (like  Quality  Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads  of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry …

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