Tag Archives: Antwerp

Preparation, Approval, Review and Control of MFC and MPC for Manufacture of Pharmaceutical Products Objective:  To lay down a procedure for the Preparation, Approval, Review and Control of MFC for Manufacture of Pharmaceutical Products. Scope:  This Standard Operating Procedure is applicable for preparation and implementation of MFR for all products …

CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER OBJECTIVE:  To lay down the procedure for calibration of Halogen moisture analyzer, Make-  Metler – Toledo. SCOPE:  This SOP shall provide the calibration procedure of Halogen moisture analyzer in in-process quality assurance  department and quality control department. RESPONSIBILITY : Officer/ Executive – Quality Control/Quality Assurance. …

Compression Machine The major components of the equipment are identified as:- Powder Feeding unit. Powder transfer unit Compression unit Hydraulic power pack assembly Discharge unit The Compression machine 26 station D tooling, a single rotary high-speed tablet press, is a machine incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power …

Tablet Compression Machine The Compression machine 26 station D tooling, a single rotary high-speed tablet press, is a machine in incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor and rejection / sampling port. The major components of the equipment are identified us:- Powder Feeding unit. Powder transfer …

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 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 …