Tag: Dunkeld

SOP of Handling of Obsolete Rejected and online rejections of raw materials Objective: To lay down a procedure for handling Obsolete / Rejected and online rejections of raw materials. Scope: This procedure is applicable to warehouse of formulation plant for Pharmaceutical Company Name). Responsibility: Store personnel shall be responsible for implementation of this SOP. Accountability:Concerned Department…

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SOP of Dispensing of Solvent Liquid Materials To lay down the procedure for dispensing of solvent / liquid materials. Scope This SOP is applicable for dispensing of solvent / liquid materials in warehouse at (Pharmaceutical Company Name). Responsibility Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP. Raw material…

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SOP of Receiving the 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 the receipt of Raw and Packing material to the warehouse of the formulation plant at (Pharmaceutical Company Name). Responsibility: Raw Material and Packing Material warehouse personnel…

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DGFT guidelines for Barcoding  For More Pharma Updates Visit https://pharmaguidances.com as per GS1 Standards Pharmaceutical For More Pharma Updates Visit –https://pharmaguidances.com

Pharma Quality Assurance Question & Answer 1.Question: What is the SOP? Answer:  SOP is abbreviation of Standard Operating Procedure SOP is a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently. 2.Question: What is the Content of SOP? Answer:…

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HVAC SYSTEM RE-QUALIFICATION PROTOCOL PHARMA TABLE OF CONTENT Approval sheet Objective Scope Responsibility Qualification Team Abbreviation and definition Prerequisites Precautions and instruction (Health, Safety and Environment) Air velocity, Air volume and air Change Per hour measurement Procedure for HEPA Filter integrity Procedure for Temperature, Relative Humidity and differential Pressure Measurement Procedure for nonviable particle count…

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TEMPLATE FOR PERFORMANCE QUALIFICATION PROTOCOL CONTENTS Topic No. Topic Protocol Preparation and Approval 1.0 Objective 2.0 Scope 3.0 Responsibility 4.0 Abbreviations & Definitions 5.0 Brief Description of Equipment 6.0 Pre-requisites 7.0 Validation Procedure 8.0 Recording/ Data compilation 9.0 Deviations and Investigations 10.0       Qualification/ Validation Report Preparation 11.0       Re-validation/Re-qualification of Equipment 12.0       Reference…

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TEMPLATE FOR OPERATIONAL QUALIFICATION PROTOCOL TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Main Operational Parameter. (Eg. RPM Verification) Operational Qualification Tests Status List of Standard Operating Procedures Data Analysis, Summary of OQ & Recommendations Amendment record Conclusion PURPOSE To describe…

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TEMPLATE FOR  INSTALLATION QUALIFICATION PROTOCOL TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion PURPOSE To describe the…

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TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS Table of Contents General Salient Features Operational Requirements Maintenance Inspection and Testing Commissioning and Documentation Training Packaging Deviations Delivery  TECHNICAL General –  Equipment No. ,Description Use – Field Identification ,Glossary Salient Features  General – Specification as per Requirement Smooth  Finish/matt finish/mirror finish Non flameproof / flameproof Material of Construction Finish Electrical Construction Operational requirements…

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EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Part I – Basic Requirements for Medicinal Products Chapter 1 Pharmaceutical Quality System (31 January 2013) Chapter 2 Personnel (16 February 2014). Chapter 3 Premise and Equipment (1 March 2015) Chapter 4 Documentation (January 2011) Chapter 5 Production (1 March 2015) Chapter 6 Quality Control (1 October 2014) Chapter 7 on…

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ICH Pharma Quality Guideline ICH Guideline Link 1. ICH GUIDELINE INDEX I. Q1A – Q1F STABILITY Q1A (R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing: Photostability Testing of New Drug Substances and Products Q1C Stability Testing for New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug…

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