Tag Archives: UGANDA

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 for Calibration of equipments and instruments from external authorized Agencies / Supplier. Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments. Responsibility Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration agency / Supplier …

Objective:To lay down a procedure for building Maintenance. Scope:This Standard Operating Procedure is applicable for the formulation plant. Responsibility Head-Engineering /Designee shall be responsible for implementation of the procedure as per this SOP. Head-Concerned Department / Area In charge shall be responsible for compliance of the procedure as per this …

Release of Finished Products Objective : To lay down the procedure for release of finished products. Scope: This SOP covers the responsibility and procedure for the approval and release of Finished Products for distribution. Responsibility Production, Finished Good Store, QC and QA personnel shall be responsible to follow the procedure …

PERFORMANCE QUALIFICATION PROTOCOL OF WATER FOR INJECTION GENERATION AND DISTRIBUTION SYSTEM Protocol Contents 1.0 Protocol Approval  2. Overview 2.1Objective:  2.2 Purpose and Scope 2.3 Responsibility 2.4 Qualification Team 3.0 Traning Record 3.1 Purpose 3.2 Scope 4.0 Performance Qualification Requirements 5.0 System / Equipment Description 5.1 System / Equipment details 5.2 …

Performance Qualification Protocol of Tunnel Sterilizer TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description 5.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording Of Observations 8.0 Discrepancy And Corrective Action Report 9.0 Compilation, Review And Summary Report …

Installation Qualification for Vibratory Sifter (Single Deck) TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 Equipment Identification 5.0 Equipment location 6.0 Documentation 7.0 Pre-requisite of Installation Qualification 8.0 Installation Qualification Procedure 9.0 System Description 10.0 Procedure 10.1 Installation Check List 10.2 Inspection Check list 10.3 Leveling and Alignment  …

OPERATIONAL QUALIFICATION OF AIR COMPRESSOR PROTOCOL APPROVAL THE OQ PROTOCOL FOR AIR COMPRESSOR, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTS Prepared by: NAME SIGNATURE DATE Approved by: FUNCTION NAME SIGNATURE DATE VALIDATION PRODUCTION SERVICES QUALITY ASSURANCE Content 1. OBJECTIVE / PURPOSE 2. PREPARATION …

INSTALLATION QUALIFICATION PROTOCOL AIR COMPRESSOR PROTOCOL APPROVAL THE IQ PROTOCOL FOR AIR COMPRESSORS, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTSPrepared by: CONTENTS INSTALLATION QUALIFICATION PAGE 1.    OBJECTIVE / PURPOSE 2.    EQUIPMENT DESCRIPTION, IDENTIFICATION, AND CHECKS 3.    MAJOR COMPONENTS 4.    EQUIPMENT CONTROL SYSTEM 5.    …

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 …

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 …