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 …

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 …

SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA CONTENTS of PROCESS VALIDATION PROTOCOL Protocol Approval Sheet Objective Scope Responsibility Validation Team Members Abbreviations Pre-requisite for Validation Manufacturing Procedure Under Validation Critical Process Steps and Process Parameters for Validation with Justification Process steps – Sampling and Analysis Plan with Acceptance Criteria …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 – …

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 …

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. …

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 …

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 …

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 …

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. …

SOP of Total Viable Spore Count Test for Biological Indicators Objective To lay down the procedure for Total Viable Spore Count and Resistance Performance test for Biological Indicators  Scope This SOP is applicable for Total Viable Spore Count and Resistance Performance test for Biological Indicators of (Pharmaceutical Company Name). Responsibility …

SOP of Culture Suspension Preparation and Preservation Objective To lay down the procedure for Preparation and Preservation of 10-100 CFU’s/0.l ml Culture Suspension. Scope This SOP is applicable for Preparation and Preservation of 10-100 CFU’s /0.1 ml Culture Suspension in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above …

SOP on Media growth Promotion, Inhibition, and Sterility Check Objective To lay down the procedure for Media Growth Promotion, Inhibition, and Sterility Check. Scope This SOP is applicable for Media Growth Promotion, Inhibition, and Sterility Checks in the Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC …