SOP of Receive the materials returned from production department Objective: To lay down a procedure to receive the materials returned from production department. Scope: This SOP is applicable to all raw and packing materials returned from production department to Warehouse of the formulation plant of (Pharmaceutical Company Name). Responsibility: Concerned …
Read More »sop of Operation of dispensing booth
sop of Operation of dispensing booth Objective:To lay down a procedure for operation of dispensing booth. Scope:This procedure is applicable to the Raw material Store at (Pharmaceutical Company Name). Responsibility: Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP. Raw material Store in-charge shall …
Read More »sop on Issue of additional Raw and Packaging materials
sop on Issue of additional Raw and Packaging materials Objective:To lay down a procedure for issuing additional raw and packing material to the Production Department. Scope:This SOP is applicable for issuing additional raw and packing material to the Production Department at (Pharmaceutical Company Name). Responsibility:Warehouse personnel shall be responsible for …
Read More »SOP for Issuance of Raw material
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 …
Read More »SOP of Issuance of packaging materials
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 …
Read More »SOP of Handling of Raw & Packaging Materials under Re-Test due
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 …
Read More »SOP of Handling of Obsolete Rejected and on line rejections of raw materials
SOP of Handling of Obsolete Rejected and on line rejections of raw materials Objective: To lay down a procedure for handling of Obsolete / Rejected and on line rejections of raw materials. Scope: This procedure is applicable to warehouse of formulation plant for Pharmaceutical Company Name). Responsibility:Store personnel shall be responsible …
Read More »SOP of Dispensing of Solvent Liquid Materials
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 …
Read More »Dispatch of Finished Goods
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 …
Read More »SOP of Receiving the raw materials and packaging materials
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 …
Read More »DGFT guidelines for Barcoding as per GS1 Standards Pharmaceuticals
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
Read More »Pharma Quality Assurance Question & Answer
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 …
Read More »HVAC SYSTEM RE-QUALIFICATION PROTOCOL PHARMA
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 …
Read More »SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA
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 …
Read More »TEMPLATE FOR PERFORMACE QUALIFICATION PROTOCOL
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 …
Read More »TEMPLATE FOR OPERATIONAL 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 …
Read More »TEMPLATE FOR INSTALATION 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 …
Read More »TEMPLATE FOR USER REQUIREMENT SPECIFICATIONS QUALIFICATION
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 …
Read More »GMP Guidelines (EU)
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 …
Read More »ICH Pharma Quality Guideline
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 …
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