QA & QC

How to face Interview

How to face Interview Remember, you never get a second chance to make a good first impression. However, good preparation takes the pain out of the process. Interview Preparation Remember: Prepare, prepare, prepare! Preparation is essential and greatly enhances your chances of performing well, So: know your CV know your …

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SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules

SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules OBJECTIVE : To provide a procedure for representative sampling of  In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the …

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SOP on Training

SOP on Training Objective:  To lay down a procedure to conduct training of working personnel at all levels and its evaluation. Scope:  This Standard Operating Procedure is applicable for the training personnel at Pharmaceuticals Companies. Responsibility Head, QA, or his/her designee for coordination on the training of the personnel. The …

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SOP on Drug Product Recalls

SOP on Drug Product Recalls OBJECTIVE : To define the procedures used to effect the recall of a marketed product once it has been decided that such a course of action is required. RESPONSIBILITY : The  Managing  Director and  Divisional  Head shall be responsible for making the decision that a  …

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Issuance and Evaluation of Product Exception Investigation Reports (“EIRs”).

Issuance and Evaluation of Investigation Reports OBJECTIVE : To establish a documentation system by which qualified representatives report  and investigate the exceptions of drug products in the manufacturing process, in-process specifications. RESPONSIBILITY : Executive – Production/Packaging to prepare the Exception Investigation Report (EIR). Head – Production to investigate and implement …

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SOP on Process Validation Programmed in Pharmaceutical Company

SOP on Process Validation Programmed in Pharmaceutical Company OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research  Development to prepare and execute the validation protocol …

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Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products

Preparation, Approval, Issue, and Control of Artworks for labeling of Pharmaceutical products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue, and Control of artworks for labeling of pharmaceutical products. RESPONSIBILITY : R&D(Packaging Development) to prepare the Artwork, positive or soft copy, and procure shade cards & specimens …

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Calibration for Weighing Balances

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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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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