Performance Qualification Report for steam sterilizer REPORT APPROVAL Performance Qualification is verified that all test cases required by the protocol are completed, reconciled and included in the qualification summary report. Signatures in the block below indicate that all items in this Qualification Report have been reviewed and found to be …

Load Pattern & Justification for steam sterilizer APPROVAL SIGNATURES Signing of this approval page of load pattern indicates agreement with the qualification approach described in PQ protocol. If any modification in the load pattern becomes necessary, a revision through change control shall be prepared, checked and approved. Wherever applicable revalidation …

Protocol for steam sterilizer and load Pattern MODEL :HORIZONTAL-RECTANGULAR LOCATION :VIAL WASHING ROOM TABLE OF CONTENTS Protocol Approval Objective Scope Equipment Description Responsibilities And Identification Of Execution Team Test Procedures Recording Of Observations Discrepancy And Corrective Action Report Compilation, Review And Summary Report Appendix Revalidation Criteria Schematics of Stem Quality …

Data Integrity : The increasingly complex regulatory environments have forced laboratories to adopt a new mindset to compliance and auditing… moving away from traditional instrument validation approaches and consolidating both the instrument data as well as the instrument support across the full spectrum of their lab assets. Contents What is …

The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection FDA Expectations • FDA conducts inspections to assess compliance with applicable laws and regulations • FDA expects: – Investigators to conduct inspections in a reasonable manner – Industry to …

Vendor Qualification SOP          To provide a procedure for identification, selection, evaluation and qualification of Raw Material (Active and Inactive) and Primary / Printed  Packaging material vendors. Responsibility of Vendor Qualification SOP     :     Head-SCM  for identification and selection of Vendor. Head – Quality Control for …

Chemical Sanitization Procedure for RO first Pass Objective : To Disinfectant the Bacteria in RO membrane Scope :- Procedure : Prepare (0.1 – 1) % Minncare Solution in any solution preparation tank having the capacity of 300 Ltr      { Use  300ml of 100% Minncare in 300 Ltrs of Purified …

Installation qualification for purified water generation system Purpose  The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that: Each installed sub-component complies with the engineering design and system data sheets/specifications. The system is installed according to the design …

SOP for sterilization of Miscellaneous Items Objective: To lay down a procedure for sterilization of miscellaneous Items. Scope: This SOP is applicable for sterilization of Miscellaneous Items. Responsibility: Officers/above (Production-Injectable) is responsible for sterilization of Miscellaneous Items. Accountability: Production Head is accountable for the implementation and compliance of this SOP. …

SOP for sterilization of cartridge Filter Objective: To lay down a procedure for sterilization of cartridge filter. Scope: This SOP is applicable for sterilization of cartridge filter pre assembled in filter housings. Responsibility: Production Officers / Executive. Accountability: Production Head shall be accountable for the compliance of SOP. Abbreviations SOP …

What is a Cartridge Filter A cartridge filter is a type of filter that employs a porous cartridge as the medium for trapping impurities from liquids or gases. It is usually made of materials like paper, polyester, or other synthetic fibers, and its design allows for efficient filtration by trapping …

SOP for delabelling and repacking of vials Objective: To lay down a procedure for Delabelling and Repacking of vials. Scope This SOP is applicable on procedure for Delabelling and Repacking of vials for Production dry powder Injection facility. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for …

SOP for cleaning of vial filling machine and its parts Objective To lay down a procedure for cleaning of vial filling machine and its parts. Scope This SOP is applicable for cleaning of vial filling machine and its parts for Production dry powder Injection facility. Responsibility Production Officers / Executive. …

SOP on cleaning of Liquid filling machine (Watson Marlon ) Objective: To lay down the procedure for cleaning of liquid filling machine (Watson Marlon). Scope This SOP is applicable for the procedure of cleaning of liquid filling machine shall be accountable for the compliance of SOP. Responsibility Production Officers / …

SOP for operation of sticker labeling machine (Maharshi) Objective: To lay down a procedure for operation of sticker labeling machine. Scope: This SOP is applicable for sticker labeling machine. Responsibility: Production operator/Technician- responsible for operation of sticker labeling machine. Production officer/ Executive – to ensure that operation of sticker labeling …

SOP for operation of shrink wrapping machine Objective: To lay down a procedure for operation of shrink wrapping machine. Scope: This SOP is applicable for shrink wrapping machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. MASTER FORMULA OF MEBENDAZOLE TABLETS Procedure: Pre-startup: …