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 …
Read More »SOP on line clearance
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. …
Read More »SOP on Monitoring of Temperature, Relative Humidity and Pressure Differential
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 …
Read More »SOP on Technology Transfer for Analytical Method
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 : …
Read More »SOP on Transfer of Technology for Manufacturing process
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: …
Read More »SOP on Execution of Exhibit Batches
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 …
Read More »Operational Qualification of Ointment Manufacturing Vessel
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 …
Read More »Preparation, hahdling, storage and discard of mobile phases
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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
Read More »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 …
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 On Document and Data Control
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 …
Read More »Sop on Corrective and Preventive Action (CAPA)
Sop on Corrective and Preventive Action 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 …
Read More »Sop on Recording of Specimen Signature
Sop on Recording of Specimen Signature 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 …
Read More »HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT To define a procedure for handling of market complaints. PRODUCT COMPLAINT SOP SCOPE This SOP shall be applicable to all the market complaints of drug products received directly or from any other source. DEFINITIONS Complaint: A market / consumer complaint is notification that a …
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