Tag Archives: Thane

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 …

WATER FOR INJECTION GENERATION AND DISTRIBUTION SYSTEM Working Principle of Water For Injection System: The Water For Injection System Still is working on the Principle of inters-stage heat exchange (Reuse of energy) to drastically reduce the consumption of heat energy and cooling water. Thus enables to production large- scale of …

Performance Qualification Protocol of Tunnel Sterilizer Tunnel Sterilizer Description: Sterilizing and depyrogenating tunnel enables the integration of the process of sterilization and depyrogenation of washed empty vials for sterile, continuous automatic filling in which all steps are performed under Grade A conditions. The Tunnel is comprised of four zones, i.e. …

Installation Qualification for Vibratory Sifter (Single Deck) TABLE OF CONTENTS Approval Objective Responsibility Equipment Identification Equipment location Documentation Pre-requisite of Installation Qualification Installation Qualification Procedure System Description Procedure 10.1 Installation Check List 10.2 Inspection Check list 10.3 Leveling and Alignment  10.4 Material of Construction Check Points  10.5 Guarantee / Warrantee …

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 1.    OBJECTIVE / PURPOSE 2.    EQUIPMENT DESCRIPTION, IDENTIFICATION, AND CHECKS 3.    MAJOR COMPONENTS 4.    EQUIPMENT CONTROL SYSTEM 5.    SAFETY …

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 …

DISPENSING BOOTH A dispensing booth is a kind of purifying equipment for materials sampling, weighing, and analysis. A dispensing booth is also called a sampling booth, a weighing booth, a downflow hood, RLAF (reverse airflow), or a powder containment booth. It uses the laminar airflow technique to provide dust containment …

The sampling booth / Dispensing booth The sampling booth / Dispensing booth is a purifying System. Unidirectional laminar flow Class ISO 5 (Class100). The Raw materials and compounds are refilling, weighing, filling, and sampling. It is provided with a high-efficiency HEPA filter, which averts the airborne dusts by down flow of …

DISPENSING & SAMPLING BOOTH The sampling Booth or Dispensing Booth is designed to provide high levels of protection from airborne contaminants generated during powder handling operations such as charging & dispensing. ( Sampling Booth or Dispensing Booth ) provides Operator Protection, Products Protection, and Environment Protection. The Sampling Booth or …

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 …