Tag: Somer en

Factory Acceptance Test for Blister Pack Machine

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Factory Acceptance Test for Blister Pack Machine machine name : BLISTER PACK MACHINE. Client Name & address : M/S BLISCARE MACHINES, MUMBAI. document name : factory  acceptance test PROTOCOL no. : Revision no. : MACHINE SR. NO. : Table of Contents 1.… SYSTEM DESCRIPTION & SALIENT FEATURES :……………………………………………………………. 2.… SYSTEM CHECKS :…………………………………………………………………………………………………………… 2.1 Physical Check…

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Qualifications & Validations

Procedure For Dispensing of Packing Materials

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              STANDARD OPERATING PROCEDURE Title : Procedure For Dispensing of Packing Materials     OBJECTIVE This SOP describes the procedure for dispensing of packing material. SCOPE This procedure is applicable to Warehouse department for dispensing of packing material. RESPONSIBILITY Officer / Executive-WH – responsible for Implementation of SOP. ACCOUNTABILITY Manager-Warehouse PROCEDURE After receiving batch requisition from…

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SOPs

Chlorzoxazone ,Nimesulide Tablet                                                

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Chlorzoxazone ,Nimesulide Tablet PURPOSE:  This Master formula record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This MFR 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…

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Tablets

PERFORMANCE QUALIFICATION OF AUTO COATER

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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…

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Qualifications & Validations, Uncategorized

SOP on Receipt of Raw Materials and Packaging Materials

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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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SOPs

Amoxycillin and Potassium Clavulanate Oral Suspension IP

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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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MASTER FORMULAS, Oral Liquid

Procedure For action to be taken during spillage /breakage of materials.

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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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SOPs

SOP For Procedure For change control system

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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…

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SOPs

Procedure for review, audit and storage of batch records and testing records

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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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SOPs

SOP For format issuance and control

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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…

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SOPs