QA & QC

SOP on Execution of Exhibit Batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharma Company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability …

SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging …

Preparation, hahdling, storage and discard of mobile phases OBJECTIVE To lay down a procedure for the  preparation , handling , storage and discard of mobile phases. SCOPE This SOP shall be applicable for preparation , handling , storage and discard of mobile phases. RESPONSIBILITY Executive/Officer – Quality control ACCOUNTABILITY Head …

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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 …

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 …

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  …

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 …

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 …

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 …