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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Read More »SOP on cleaning and operating procedure of bursting strength tester
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 …
Read More »Effluent Treatment Plant (ETP)
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 …
Read More »Validation Observations Recording for steam steriliser and load Pattern
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 …
Read More »Handling of Microbiological Data Deviation in Microbiology Laboratory
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 …
Read More »OOS in Microbiology
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 …
Read More »Performance Qualification Report for steam steriliser
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 …
Read More »Load Pattern & Justification for steam sterilizer
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. …
Read More »Protocol for steam sterilizer /Autoclave and load Pattern
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. …
Read More »US FDA Data Integrity
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 …
Read More »Things to Do When FDA Staff Are on Site to Conduct an Inspection
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 …
Read More »Vendor Qualification SOP
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 …
Read More »Sanitization & Cleaning SOP ( RO )
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 …
Read More »Installation qualification for purified water generation system
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 …
Read More »SOP for sterilization of Miscellaneous Items
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. …
Read More »SOP for sterilization of cartridge Filter
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 …
Read More »Cartridge Filter
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 …
Read More »SOP for delabelling and repacking of vials
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 …
Read More »SOP for cleaning of vial filling machine and its parts
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. …
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