Objective: To lay down the procedure for Fogging of Microbiology Testing Areas Scope: This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once …

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Objective: To lay down the cleaning & operating procedure of bursting strength tester. Scope: This SOP is applicable for the cleaning & operating procedure of bursting strength tester in quality control laboratory. Responsibilities: Chemist or above of QC laboratory in Packaging material Quality Control section is responsible for carrying out …

Effluent Treatment Plant (ETP) Effluent Treatment Plants (ETP) play a vital role in this endeavor, serving as essential systems for the treatment and purification of industrial wastewater. This article explores the importance, operation, and environmental implications associated with Effluent Treatment Plants. Effluent Treatment Plants are crucial for the responsible and …

Validation Observations Recording Format -I for steam sterilizer and load Pattern Recording Of Observations For Revalidation Steam Quality Tests 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 …

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 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 …