Validation Observations for steam sterilizer and load Pattern Recording Of Observations For Revalidation Steam Quality Tests 1. Steam Non-Condensable Gas Test When the temperature of the water in the container reaches 70-75°C close the needle valve. Note the volume of gas collected in the burette (Vb) and the volume of …

Objective: To lay down the procedure for Handling of Microbiological Data Deviation in Microbiology Laboratory. Scope: This procedure is applicable to environmental monitoring excursions (namely Passive air sampling, Active air sampling, Surface sampling, Personnel monitoring, and Compressed gas monitoring)obtained during the Environmental monitoring, Sterility testing, Bacterial Endotoxin Test, Bioburden, Microbial …

OOS in Microbiology Out-of-specification (OOS) occurrences pertain to situations where microbiological test outcomes deviate from predetermined acceptance criteria or specifications. These occurrences can arise due to a variety of factors, spanning from technical complications to procedural mistakes. The identification and resolution of OOS events play a crucial role in upholding …

Performance Qualification Report for Steam Sterilizer 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 acceptable. SUMMARY …

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

Steam sterilizer /Autoclave (HPHV) Steam sterilizer (H.P.H.V. ) is for sterilization and drying of garments, rubber stopper holding canisters, filling machine parts, filtration accessories, and previously washed and siliconized rubber stoppers. H.P.H.V. Steam sterilizer is installed in the vial washing room. Basic Mode of Operation The main action of H.P.H.V. …

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 This Installation Qualification Protocol shall be performed on the Purified Water Generation System. This protocol defines the methods and documentation that shall be used to evaluate the system for installation by the manufacturer’s specifications and intended use. Successful completion of this protocol shall …

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 …