Tag Archives: Myaanmar (Burma)

Objective:To lay down a procedure for Transfer of Finished Products from Production to Finished Goods Store. Scope:This standard operating procedure is applicable for formulation plant. Responsibility Production Supervisor / Officer shall be responsible for checking the COA from QC, product name, batch number, date of manufacturing, date of expiry, quantity …

OBJECTIVE :To lay down a procedure for collection, storage, retrieval and disposition of Control samples of drug products. RESPONSIBILITY :Quality Assurance Officer for collection, storage, retrieval and disposal of Control samples. Head of  Quality Assurance Department to ensure compliance. PROCEDURE :Every batch/lot of each drug product in all forms of its …

Responsibilities of Quality Assurance Department OBJECTIVE: To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation of cGMP …

In-process checks during Packaging Operation of tablets and capsules OBJECTIVE : To lay down the procedure for in-process checks during packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE: Inspection of Packaging Materials : Production …

RESPONSIBILITY :Personnel of the concerned department to calibrate the instrument/equipment and investigate the failure, if any. OBJECTIVE :To lay down policy for calibration of Instruments/Equipment’s wherever applicable. Heads of the  concerned department to ensure compliance. Procedure : All the instruments associated with the processing and testing of materials and products shall be calibrated. …

Numbering System for Qualification Documents, Protocols and Reports Objective  To lay down a procedure for assigning of number for qualification documents, protocols and reports. Scope  This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and …

Installation, Operational and Performance qualification of Equipment/Instrument. OBJECTIVE : To lay down the procedure for Installation, Operation and Performance qualification of Equipment/Instrument. RESPONSIBILITY : Validation team comprising of representatives from functional department,Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. …

Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material Objective:  To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Re-qualification of existing approved vendors. Scope: This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Re- qualification …

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 …

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 …

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, …

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 …

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 …

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 …

 Label claim : Each uncoated modified release  tablet contains Gliclazide Ph. Eur …………60 mg                                 Master Formula No. :   Product Code :                              …

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 …

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 …

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 …

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 …

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 …