Tag: Rutland

Validation Observations Recording for steam steriliser and load Pattern

Posted on By Pharmaceutical Guidanace

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 water collected in the measuring…

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Validation & Qualification

Handling of Microbiological Data Deviation in Microbiology Laboratory

Posted on By Pharmaceutical Guidanace

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 Limit test, Liquid borne particulate…

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Microbiology, QA & QC

OOS in Microbiology

Posted on By Pharmaceutical Guidanace

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 the dependability of microbiological data,…

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Microbiology, QA & QC

Performance Qualification Report for steam steriliser

Posted on By Pharmaceutical Guidanace

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 REPORT Data generated during qualification…

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Validation & Qualification

Load Pattern & Justification for steam sterilizer

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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. Wherever applicable revalidation of the…

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Validation & Qualification

Protocol for steam sterilizer /Autoclave and load Pattern

Posted on By Pharmaceutical Guidanace

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. Steam sterilizer on all the…

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Validation & Qualification

US FDA Data Integrity

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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 Data Integrity?  Regulatory Environments…

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Audit and Guideline

Things to Do When FDA Staff Are on Site to Conduct an Inspection

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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 welcome the investigator professionally and…

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Audit and Guideline

Vendor Qualification SOP

Posted on By Pharma Editor

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 testing of samples. Head –…

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Uncategorized

Installation qualification for purified water generation system

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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 verify that this system meets…

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Validation & Qualification

SOP for sterilization of Miscellaneous Items

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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. Abbreviations SOP : Standard Operating…

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Production

SOP for sterilization of cartridge Filter

Posted on By Pharma Editor

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 : Standard Operating Procedure MMI…

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Production

SOP for delabelling and repacking of vials

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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 the compliance of SOP. Abbreviations…

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Production

SOP for cleaning of vial filling machine and its parts

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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. Accountability Production Head shall be…

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Production

SOP on cleaning of Liquid filling machine (Watson Marlon )

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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 / Executive. Accountability Production Head shall…

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Production

SOP for operation of sticker labeling machine (Maharshi)

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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 machine is carried out as…

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Production

SOP for operation of shrink wrapping machine

Posted on By Pharma Editor

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: Check the status of the…

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Production

SOP on cleaning of shrink wrapping machine

Posted on By Pharma Editor

SOP on cleaning of shrink wrapping machine Objective: To lay down a procedure for cleaning of shrink wrapping machine. Scope This SOP is applicable for cleaning of shrink wrapping machine in production area. Responsibility Production operator / technician – responsible for cleaning of machine. Production officer / Executive – to ensure that cleaning of the…

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Production