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Questionnaire for preparing a commercial proposal for GMP audit/inspection
Your company name
In which country is the manufacturing site located?
*
Which stages of the manufacturing process are planned for audit/inspection?
*
Full production cycle
Manufacturing of finished dosage form (bulk)
Primary packaging
Secondary packaging
Quality control (physicochemical parameters)
Quality control (microbiology)
Quality control releas
Does the manufacturer have a valid GMP certificate issued according to the national requirements of an EAEU member state or EAEU requirements?
*
Yes
No
Has the application for GMP inspection already been submitted to the authorized body?
*
Yes
No
What support do you need?
*
Preparation of the site for inspection with a preliminary audit
Preparation of the site for inspection without an audit (sending a checklist, list of typical observations, teleconference with the site (Q&A session)
Response to the authorized body's and/or inspectors' request before the inspection
Accompanying the inspectorate during the site visit
Support in preparing a corrective and preventive action plan (CAPA) based on inspection results
Other
What dosage forms are planned to be manufactured at the site for the EAEU market?
*
Aerosol
Gas
Spray
Capsules
Gel
Solution
Concentrate
Granules
Stick
Cream
Liniment
Suppositories
Dispersion
Lyophilisate
Suspension
Drops
Ointment
Syrup
Emulsion
Oil
Tablets
Extract
Paste
Tampon
Film
Patch
Tincture
Foam
Powder
Other
Will sterile dosage forms be produced at the site for the EAEU market?
*
Yes
No
Has this manufacturing site been approved as part of the registration dossier for a medicinal product in any EAEU member state?
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Yes
No
Additional conditions and requests
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*
Email
*
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