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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SOP For Procedure For change control system OBJECTIVE To lay down the Procedure for change control System. SCOPE The purpose of this SOP is to describe in details the change control process. This procedure starts from initiation to the implementation of the change at Pharmaceutical Company. RESPONSIBILITY Originating/ initiating Department: To initiate the…
Procedure for review, audit and storage of batch records and testing records Objective: To lay down a procedure for review, audit and storage of batch records and testing records. Scope: This procedure is applicable to Quality Assurance, Quality Control and Production department of Formulation Plant of Pharmaceutical Company. Responsibility: QA officer / executive shall be…
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SOP For format issuance and control OBJECTIVE To lay down the Procedure for format issuance and control. SCOPE RESPONSIBILITY Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance. PROCEDURE DOCUMENT CONTROL & ISSUANCE All formats originating from the SOPs shall be taken on a stand This SOP is applicable for all departments to control documents, which are Approved and…
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…
