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…
Read More “SOP of Receiving the raw materials and packaging materials” »
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…
Read More “TEMPLATE FOR PERFORMACE QUALIFICATION PROTOCOL” »
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…
Read More “TEMPLATE FOR OPERATIONAL QUALIFICATION PROTOCOL” »
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…
Read More “TEMPLATE FOR INSTALATION QUALIFICATION PROTOCOL” »
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…
Read More “TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS QUALIFICATION” »
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 &…
Read More “SOP of Operation and backwash of Multi grade filter” »
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….
Read More “SOP on operation, cleaning and maintenance of the Stericheck system” »
SOP of Hot Air Oven Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven. Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability…
SOP of Vortex mixer Objective To lay down the procedure for Operation and Cleaning of Vortex mixer Scope This SOP is applicable for Operation and Cleaning of Vortex mixer in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. / Nominee….
SOP of Media Decontamination and Disposal after used Objective To lay down the procedure for Decontamination and Disposal of Used Media Scope This SOP is applicable for Decontamination and Disposal of Used Media. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. /…
Read More “SOP of Media Decontamination and Disposal after used” »
SOP of LAL Reagent Objective To lay down the procedure Confirmation of Labeled LAL Reagent Sensitivity. Scope This SOP is applicable for Confirmation of Labeled LAL Reagent Sensitivity tested in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control I Nominee….
SOP On Temperature Monitoring of Microbiology Equipment’s Objective To lay down the procedure for Temperature Monitoring of Microbiology Equipment’s. Scope This SOP is applicable for Temperature Monitoring of Microbiology Equipment’s like incubators and refrigerator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section /…
Read More “SOP of Temperature Monitoring of Microbiology Equipments” »
