Category: SOPs

Quality Management Review Objective To lay down a procedure for Quality Management. Scope This Standard Operating Procedure shall apply to formulation plant of Pharma Company. Responsibility Head Quality Assurance shall be responsible for compliance of this SOP. Heads of Production, QC, Stores, Engineering, and Human Resource etc. shall be responsible for implementation and compliance of…

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STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit    OBJECTIVE To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments RESPONSIBILITY It is a joint responsibility of all self-inspection team members in coordination with Quality Assurance….

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Cleaning of  SS Trolleys, Pallets and Racks Objective To lay down a procedure for cleaning of SS Trolleys, Pallets and Racks Scope This SOP is applicable for cleaning of SS Trolleys, Pallets and Racks in Raw Material Store/packing material/finished good at formulation plant of  Pharma Company. Responsibility Store personnel shall be responsible to follow the…

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Operation and Cleaning of Refrigerator Objective To lay down a procedure for Operation and Cleaning of Refrigerator in Raw Material Store. Scope This Standard Operating Procedure is applicable for operation and cleaning of Refrigerator in Raw Material Store at formulation plant of  Pharma Company. Responsibility Raw material Store personnel shall be responsible to follow the…

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Handling of Fallen off / Damaged Status labels Objective To lay down a procedure for Handling of Fallen off / Damaged Status labels. Scope This Standard Operating Procedure is applicable for Handling of Fallen off / Damaged Status labels of Raw Material /Packing material at formulation plant of Pharma Company. Responsibility Concerned Department personnel shall…

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 STANDARD OPERATING PROCEDURE Title: Procedure For  handling of returned goods OBJECTIVE  To lay down a procedure for handling of returned goods. SCOPE This procedure is applicable for handling the retuned goods. RESPONSIBILITY Manager-Quality Control Manager-Warehouse ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Returned goods in general belongs to: Recalled product in-case of product recall. Returned saleable finished goods….

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STANDARD OPERATING PROCEDURE Title : Procedure For line clearance activities during processing of product  OBJECTIVE To lay down the procedure for Line Clearance. SCOPE This procedure is applicable for line clearance activities during processing of product. RESPONSIBILITY Officer-Production Officer-IPQA/QA ACCOUNTABILITY Manager-Production Manager-Quality Assurance PROCEDURE Officer-Production should place the line clearance status board after ensuring the…

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  STANDARD OPERATING PROCEDURE Title : Procedure For Internal Facility Audit Department : Quality Assurance OBJECTIVE  To lay down the procedure for carrying out Self Inspection of various departments. SCOPE This procedure is applicable for carrying out the self inspection of all departments. RESPONSIBILITY It is a joint responsibility of all self-inspection team members in…

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STANDARD OPERATING PROCEDURE Title :  Procedure For Good Documentation Practices Department : Quality Assurance OBJECTIVE                                                       To lay down a procedure for good documentation practices. SCOPE This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments. RESPONSIBILITY Officer/Executive-QA. ACCOUNTABILITY Manager-Quality Assurance PROCEDURE Design and Preparation…

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