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

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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