PROCEDURE FOR IN-HOUSE & OUTSIDE PARTY CALIBRATION Calibration defines measurement parameters such as range, accuracy, and precision of an instrument. It is one of the major parts of pharmaceutical manufacturing standards and quality assurance.
SOP on In-process sampling of semi-finished product Objective: To lay down the procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product samples. Production personnel are…
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SOP on the 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 Pharmaceutical company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability The Head of the…
SOP on withdrawal, storage, observation & destruction of control/retention sample Objective: To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from production (Oral & Injectable), and…
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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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