SOP for Issuance of Raw material Raw materials are the foundation of pharmaceutical manufacturing. These essential components are sourced from various suppliers and play a crucial role in the quality and efficacy of the final product. Ensuring the purity and integrity of raw materials is vital to meet regulatory standards and deliver safe medications to…
SOP of Issuance of packaging materials Objective:To lay down a procedure for issuance of packaging materials and transfer of issued materials from warehouse to production area. Scope:This procedure is applicable for issuance of packaging materials and transfer of issued materials from warehouse to production area of the formulation plant at (Pharmaceutical Company Name). Responsibility: Packing…
SOP of Handling of Raw & Packaging Materials under Re-Test due Objective:To lay down a procedure for Handling of Raw & Packaging Materials under Re-Test due. Scope:This SOP is applicable to all raw & packaging materials under retest due in warehouse at (Pharmaceutical Company Name). Responsibility: Concerned Store personnel shall be responsible for intimating Quality…
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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…
Dispatch of Finished Goods Objective of this SOP – Dispatch of Finished Goods: To lay down a procedure for dispatching finished goods from the finished goods warehouse. Scope: This SOP is applicable for the finished goods warehouse of the formulation plant Responsibility: Finished Goods Store personnel shall be responsible to follow and implementing the procedure…
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:…
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…
SOP for Product Process Qualification(PPQ) /Process Validation in Pharma HANDLING, MANAGEMENT AND INVESTIGATION OF DEVIATION
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…
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…
SOP of Operation and backwash of Multigrade filter Objective To lay down the procedure for operation and backwash of Multigrade filter. Scope This SOP is applicable for operation and backwash of Multigrade filter.to formulation plant of Pharmaceutical Company. Responsibility Technician/above –Eng. is responsible for operation and backwash of Multi grade filter. Accountability Department Head &…
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SOP on Media Preparation Objective: To lay down the procedure for Preparation of Media. Scope: This SOP is applicable for preparation of sterile media used in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control Head – Quality Assurance. Abbreviations and Definitions…
SOP on operation, cleaning and maintenance of the Steri-check system Objective: To lay down a procedure for operation, cleaning and maintenance of the Steri-check system. Scope: This SOP is applicable to Steri-check system present in the microbiology lab of (Pharmaceutical Company Name). Responsibility: Officer or above of Microbiology Laboratory: Head – Microbiology section / Nominee….
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