SOP on preparation, control, issuance, and revision of Batch Manufacturing and Batch Packing Records Scope: This procedure is applicable to the manufacturing & packing records being generated at the formulation Plant of a Pharmaceutical company. Responsibility: Executive Production – Preparation of BMR / BPR. Head Production / nominee – Checking / Review of BMR /…
SOP on line clearance Objective: To lay down the procedure for line clearance of manufacturing, warehouse . This is to ensure that the start up of any production/ process is free from previous material/contaminants. Scope: This SOP is applicable for line clearance of production (oral), warehouse areas of Formulation plant. Responsibility: Operator/ Supervisor shall be…
SOP on Monitoring of Temperature, Relative Humidity, and Pressure Differential Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in controlled areas. Scope: This SOP is applicable for monitoring and recording the temperature (°C), Relative humidity (%), and differential pressure (Pa) in controlled areas using a wet and dry bulbs…
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SOP on Technology Transfer for Analytical Method Objective: To lay down the procedure for the Transfer of Technology for Analytical Methods. Scope: This procedure is applicable for the Transfer of technology for Analytical Methods from ARD to a Pharmaceutical Plant. Responsibility: The responsibility of Sending Unit (ARD ) are : Preparation of Technology transfer Protocol…
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SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for the Transfer of Technology for the Manufacturing Process. Scope: This procedure is applicable for the Transfer of technology (i.e. for the Manufacturing process) from sending unit ( R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibilities of Sending Unit (R&D…
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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 The Head of the Department…
Operational Qualification of Ointment Manufacturing Vessel PURPOSE: To describe the Operational Qualification of Ointment Manufacturing Vessel, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing…
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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 – Quality Assurance Procedure for…
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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 head of every department shall…
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 recall is necessary, based on…
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 necessary corrective actions. Head – …
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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 and to prepare a final…
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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 from the printers. QA (Documentation)…
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 is a fundamental process that…
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 Head QC/QA PROCEDURE Precautions: Make …
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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 the received drug product. Officer…
SOP On Document and Data Control Objective:To lay down a procedure for control of documents and documented data. Scope:This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible to follow this SOP for maintaining control…
SOP on Corrective and Preventive Action (CAPA) In Pharma Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence. Scope : This Standard Operating Procedure shall apply to all corrective and preventive action…
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SOP on Recording of Specimen Signature Pharma Objective : To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for the recording of specimen signatures of all the personnel working at Pharmaceutical Company (Name). Responsibility Concerned personnel of all departments shall be responsible for following the procedure written in the…
SOP OF HANDLING OF MARKET COMPLAINT IN PHARMA OBJECTIVE: To lay down the procedure for Handling of Market Complaint. SCOPE: This procedure is applicable for handling of market complaints received from contract giver Regulatory Agencies, Wholesaler, Distributor, Retailer, Customer, Physicians and Patients. RESPONSIBILITY: QA Head/Executive/Designee: To log in to the market complaint log book. To prepare Primarily…
