Tag: Lebday

Why disinfectant sterilization required in pharma injectable?

Posted on By Pharmaceutical Guidanace

Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects and  reduces the…

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Microbiology

SOP on Transfer of Technology for Manufacturing process

Posted on By Pharmaceutical Guidanace

SOP on Transfer of Technology for Manufacturing process Objective: To lay down the procedure for Transfer of Technology for Manufacturing Process. Scope: This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit (F R&D) to receiving site (Manufacturing facility ) Responsibility: Responsibility of Sending Unit (F R&D ) are :…

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Quality Assurance

INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

Posted on By Pharmaceutical Guidanace

AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM The air handling unit (AHU-GF-02) is a recirculation system, in double-skin modular construction. AHU will have an extruded aluminum frame with a sandwiched panel of G.I. sheet duly pre-coated from the outside & 43 mm thick PUF filled in between. Fresh air enters through a 10µ fresh air…

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Validation & Qualification

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

Posted on By Pharmaceutical Guidanace

 FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM The Purified Water from the upstream generation System is stored in a Vertical Jacketed Storage tank From the storage tank the water is then supplied to various user points in the Production area. The Purified Water storage tank is controlled with the help of a capacitance-type level transmitter,…

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Engineering, Validation & Qualification

USFDA Critical Observation 2019 in Brief – In pharmaceutical Company

Posted on By Pharmaceutical Guidanace

USFDA WARNING LATTER 2019 – DRUGS   Reference Number Short Description Critical Observation and discripancies 21 CFR 211.22(d) Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. 21 CFR 211.192 Investigations of discrepancies, failures There is a failure to thoroughly review…

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USFDA WARNING LETTER

SOP on Fogging of Microbiology Testing Areas

Posted on By Pharmaceutical Guidanace

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 in a week at the…

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Microbiology

SOP on cleaning and operating procedure of bursting strength tester

Posted on By Pharmaceutical Guidanace

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 the cleaning & analysis as…

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Quality Control

Effluent Treatment Plant (ETP)

Posted on By Pharmaceutical Guidanace

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 sustainable management of industrial wastewater….

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Engineering

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

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

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

Posted on By Pharma Editor

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