Procedure For Document Storage Period STANDARD OPERATING PROCEDURE Title : Procedure For Document Storage Period OBJECTIVE To define the procedure for Document Storage Period. SCOPE This procedure is applicable to Quality Assurance Department. RESPONSIBILITY Officer-Quality Assurance Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance PROCEDURE The Batch Manufacturing Records and Batch Packing Records along with all…
Procedure For Annual Product Quality Review STANDARD OPERATING PROCEDURE Title : Procedure For Annual Product Quality Review OBJECTIVE To lay down a procedure for Annual Product Quality Review. SCOPE This procedure is applicable to Quality Assurance Department for annual product review of finished products . RESPONSIBILITY Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance VP – Plant…
Procedure For Product Recall STANDARD OPERATING PROCEDURE Title : Procedure For Product Recall OBJECTIVE To lay down the Procedure for product recall. SCOPE This Procedure is applicable for Handling of Product Recalls at Pharmaceutical Company. RESPONSIBILITY It is a Joint responsibility of the Marketing Department in coordination with Quality Assurance Head-Export / Company Appointed Business agent of the country in coordination with Quality Assurance. Manager – Quality Assurance ACCOUNTABILITY Manager-QA VP-Plant & Operations….
NAME OF EQUIPMENT : Auto coater 36 “ MAKE : Samarika Pharma MODEL NO. : EQUIPMENT ID. NO. : DEPARTMENT : Production LOCATION / ROOM ID.NO. : Coating Room PROTOCOL REFERENCE No. : EFFECTIVE DATE : TABLE OF CONTENTS SR. No. CONTENT PAGE No. 1.0 Qualification Report Pre-approval 2.0 Objective & scope 3.0 Responsibilities 4.0…
Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry date to the finished products manufactured. Scope This procedure shall be applicable to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry date to batch of finished product…
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SOP on Receipt of Raw Materials and Packaging Materials Objective: To lay down a procedure for receiving the raw materials and packaging materials. Scope: This SOP is applicable for receipt of Raw and Packing material to warehouse of formulation plant. Responsibility: Officer or above-warehouse is responsible for receipt of raw materials and packing materials Accountability:…
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Master Formula Record Amoxycillin and Potassium Clavulanate Oral Suspension IP INDEX Sr. No. Particulars Page No. 1 Purpose 03 2 Objective 03 3 Scope 03 4 Responsibility 03 5 Product Detail 04 6 Process Flow Material Dispensing Process. 05 7 Process Flow Chart of Filling Process. 06 8 Process Flow Chart of In Process…
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Procedure For action to be taken during spillage /breakage of materials 1.0 OBJECTIVE To lay down procedure for action to be taken during spillage /breakage of materials. SCOPE 2.1 This procedure is applicable to Warehouse and Quality Control departments for equipment cleaning and operation at pharmaceutical company. RESPONSIBILITY Warehouse Chemist concerned department – To clean…
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Procedure for the Cleaning of Comminuting Mill Objective To lay down the procedure for the Cleaning of Comminuting Mill. Scope This Standard Operating Procedure is applicable for formulation plant Make: Clit, Responsibility Trained worker / Operator shall be responsible for cleaning the machine as per this SOP. Production Supervisor / Officer shall be responsible for…
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MFR OF MULTIVITAMIN SYRUP PURPOSE: This Master Formula is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production…
