OBJECTIVE : To lay down a procedure for Maintenance of Air Handling Unit. SCOPE: This SOP is applicable to Air Handling Unit at Formulations II Service floor. RESPONSIBILITY: Technical Supervisor / Engineer . ACCOUNTABILITY: Head of Department and Head QA. PROCEDURE: Daily Maintenance : Check and ensure that the difference between inlet and outlet temperature …
Read More »SOP on Filtration of disinfectant solution and water for injection through cartridge filter.
Objective:To lay down a procedure on filtration of disinfectant solution and water for injection through cartridge filter. Scope:This SOP is applicable for filtration of disinfectant solution and water for injection through cartridge filter. Responsibility:Officers or above – Production. Accountability Production Head and QA Head. Procedure Pre Start up Check that …
Read More »PERFORMACE QUALIFICATION PROTOCOL OF DISPENSING BOOTH
PERFORMANCE QUALIFICATION PROTOCOL OF DISPENSING BOOTH TABLE OF CONTENT Description Page No Performance Qualification Protocol Approval Objective Scope Responsibility Pre requisite Reference Testing Procedure · Airflow Laminarity by Smoke Test · Non viable particle count · Viable particle count Performance qualification summary and conclusion Abbreviation Performance Qualification Approval Particle …
Read More »OPERATIONAL QUALIFICATION PROTOCOL OF DISPENSING BOOTH
OPERATIONAL QUALIFICATION PROTOCOL OF DISPENSING BOOTH TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Air Velocity Test HEPA Filter Integrity Test Differential Pressure across Filters Operational Qualification Tests status List of Standard Operating Procedures Data Analysis, …
Read More »INSTALLATION QUALIFICATION PROTOCOL OF DISPENSING BOOTH
INSTALLATION QUALIFICATION PROTOCOL OF DISPENSING BOOTH 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 Critical Instrument Calibration Verification Installation Qualification Tests Status Data Analysis, Summary of …
Read More »OPERATIONAL QUALIFICATION PROTOCOL FOR COATING MACHINE
OPERATIONAL QUALIFICATION PROTOCOL FOR COATING MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Variable RPM verification Operational Qualification Test Status List of Standard Operating Procedures Data Analysis, Summary of OQ & Recommendations Amendment record Conclusion …
Read More »INSTALLATION QUALIFICATION PROTOCOL FOR COATING MACHINE
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 »Process Validation Protocol For Gliclazide Modified Release Tablets
Label claim : Each uncoated modified release tablet contains Gliclazide Ph. Eur …………60 mg Master Formula No. : Product Code : …
Read More »Compression Machine – Qualification
Compression Machine – Qualification (Operational) Compression Machine – Qualification (Operational) (OQ) involves identifying and inspecting equipment features that can impact final product quality Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by …
Read More »Compression Machine IQ (Installation Qualification)
Compression Machine IQ (Installation Qualification) Compression Machine IQ is a documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist. Installation qualification of Compression machine IQ requirements for equipment includes …
Read More »OQ of Blister Packing Machine (BQS)
OQ of Blister Packing Machine (BQS) TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Testing of Programmable Logic Controller’s Processor Verification of Man Machine Interface Screens – MMI Power & Emergency Failure Recovery Verification Emergency Operation Verification Verification of Alarms Operational Qualification Tests Status List of Standard Operating …
Read More »IQ of Blister Packing Machine (BQS)
IQ of Blister Packing Machine (BQS) TABLE OF CONTENT of IQ of Blister Packing Machine (BQS) 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 Critical Instrument Calibration Verification Installation Qualification …
Read More »DQ of CONTA BLENDER
DQ of CONTA BLENDER TABLE OF CONTENT of DQ of CONTA BLENDER Objective Scope Responsibilities Machine description Operating control panel Main electric Panel Program of Bin Blender Program Data Program Spares Technical Specifications of Components & Sub-Components used/ bought outs Details of Utilities Identification of component for calibration Material of …
Read More »DQ for Purified Water System
DQ for Purified Water System NAME OF THE SYSTEM : PRETREATMENT & PURIFIED WATER GENERATION SYSTEM TABLE OF CONTENTS SR. NO. STAGE 1 OBJECTIVE & SCOPE 2 ACCEPTANCE CRITERIA 3 RESPONSIBILITY 4 SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM) 5 BASIS OF DESIGN AND ASSUMPTION 6 TECHNICAL SPECIFICATIONS 7 DRAWINGS REQUIRED 8 SUPPORTING …
Read More »USFDA Warning Letters 2016 (API)
Corden Pharma Latina S.p.A. 5/20/16 Megafine Pharma Limited 5/19/16 BBT Biotech Gmbh 5/16/16 Tai Heng Industry Co., Ltd. 5/12/16 Polydrug Laboratories Pvt. Ltd. 4/14/16 Apotheca Supply, Inc 4/7/16 Pharma More Jobs and post Please click here
Read More »DQ of Fluid Bed Processor
TABLE OF CONTENT OBJECTIVE SCOPE RESPONSIBILITIES MACHINE DESCRIPTION FLUID BED DRYER FLUID BED PROCESSOR LOADING & UNLOADING OF MATERIAL EQUIPMENT SUBASSEMBLIES & PARTS MAIN BODY AIR INLET SHUT OFF VALVE BLOWER INLET SHUT OFF VALVE AIR PREPARATION UNIT PRODUCT CONTAINER & TROLLEY DEHUMIDIFIER & MIST ELIMINATOR EXPLOSION FRAME & FLAP …
Read More »DQ of Blister Packing Machine (BQS)
DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS) To design, engineer, and supply the Blister Packing Machine (Model: BQS) as per the URS and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there …
Read More »SOP on Requisition, Receiving and Counter Checking of Issued Raw Materials
Objective:To lay down a procedure for Requisition, Receiving and Counter Checking of issued Raw Materials. Scope :This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company. Responsibility: Trained Worker / Operator shall be responsible for performing the procedure as per this SOP. Production Supervisor / Officer shall be …
Read More »Review of Batch Manufacturing Record
Review of Batch Manufacturing Record Objective: To lay down a procedure for the review of batch manufacturing records. Scope: This Standard Operating Procedure is applicable for formulation plants of a Pharma company. Responsibility: Officer / Executive, Quality Assurance shall be responsible for reviewing Batch Manufacturing Record. Head – Quality Assurance …
Read More »In-process Controls in Tablet Compression and Capsule filling
In-process Controls in Tablet Compression and Capsule filling Objective: To lay down a procedure for conducting Inprocess Controls during Tablet Compression and Capsule Filling. Scope: This standard operating procedure is applicable to the formulation plant of a Pharmaceutical company. Responsibility: The production Executive / Officer shall be responsible for the …
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