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Wednesday, July 6, 2011

Sterile dosage form manufacturing facility inspection audit questionnaire

Sterile dosage form manufacturing facility inspection / audit questionnaire

Complete list or questionnaire for sterile dosage form or injection, parentral dosage form manufacturing facility audit, inspection.

When we say there is no less important steps or more important steps or points in pharmaceutical manufacturing process, rather each and every steps in pharmaceutical manufacturing process are equally very important, as those are directly related to patients believing on the dose we manufacture.

Even we always see the sterile dosage forms or injectable dosage form or parantral dosage form as one of critical dosage form, as it is administered directly in to patients blood, and so will be the crosscontaminats, pyrogens and particulate matter and the result could be life threatening for patients and never the less to the firm as well .Which is why a periodic internal inspections and internal audits are of great value in building quality assurance system which will lead us to wards a error proof manufacturing systems which do not allow any error to occur.

We learn lot of things when we ask questions, that is one reason, we have given almost complete list of questionnaire for auditing or conducting facility inspection for sterile dosage forms/Injectable dosage form/parentral dosage form production facility ( manufacturing company )


http://whoguideline.blogspot.com/2011/06/inspection-and-facility-audit.html
see questions on following points see:
Aseptic Sterilization Systems. 
Dry Powder Filling.
Dry Fill Validation and Placibo Fill Validation
Filter Validation and Microbial challenge

http://whoguideline.blogspot.com/2011/07/aseptic-filling-facility-inspection.html
see for questions on following points

Aseptic Filling.
Aseptic filling Validation

http://whoguideline.blogspot.com/2011/07/laboratory-audit-sterile-dosage-form.html
see questions on following points.
LABORATORY
1.Stability and Expiration Dating
2.Sterility Testing
3.Pyrogen Testing
4. Environment

CALIBRATION 
Computer systems , 21 cfr part 11 compliance.


http://whoguideline.blogspot.com/2011/06/sterile-drug-manufacturing-facility.html
See questions on following points :
COMPONENT STORAGE AND PREPARATION ,
EVALUATION SYSTEMS.
MAJOR SYSTEMS AND PROCESSES.


http://whoguideline.blogspot.com/2011/06/sterile-drug-injectable-dosage-form.html
See questions on following points :
Chemical Sterilization/Disinfection/Sanitization.
Chemical Sterilization Validation
Ethylene Oxide Gas Sterilization (EtO)
Ethylene Oxide Validation.

Also see : Sterile drug manufacturing facility audit considerations

Also see  questions for  Biological  Indicator Usage.



Also see
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of  pharmaceutical product to foreign countries
--------------------------------------------------------------------------------------------------------

Process Validation guidelines Series 

Process Validation documentation.

Pharma process validation and concurrent release of PPQ batches

Process validation aspects of Analytical Methodology.

Process Validation Stage 3 The Continued Process Verification.

Process Validation : Process Qualification and Process Performance Qualification (PPQ)

Process Design and Process Validation Recommendations

Process validation and its regulatory, statutory requirements.

Process Validation and Drug Quality Approach to Process Validation.

General Considerations for Process Validation and Recommendations


Pharmaceutical Validation

Clean Room Classification

Quality by designe concept for pharmaceutical industry

Quality by designe concept in pharmaceutical industryan explanation

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables

What is an Isolator in pharmaceutical manufacturing

What is a Laminar Air Flow Cabinet?

21 cfr part 11 FDA guidelines .

Media Fill Run To Ensure Sterility In Sterile Dosage Forms

What is HEPA filter?

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