Certification process for cGMP

Once your management system is fully documented and has been operating for at least 3 months you may then proceed with registration. The eight steps to certification are outlined below along with the costs:

Steps To cGMP Certification

Step 1

Complete the Enquiry / Application Form (Please click on the link to go to the form) then submit form to your local office.

Step 2

Once we have received your Enquiry / Application form we shall send you a Core Questionnaire for completion.

Step 3

On receipt of the completed questionnaire a formal quotation will be sent to you.

Step 4

If you find our quotation is acceptable, please sign it and return it to your local office

Step 5

We will arrange and conduct an on-site document and readiness review. We will leave a copy of our report with any findings with you and if satisfactory arrange a mutually convenient date for the on-site audit.

Step 6

We conduct an on-site audit once it is agreed that you are ready to move forward. We produce a report on the findings plus recommendations. Unsuccessful audits may require a re-audit.

Step 7

The Certificate of Registration is issued, once all points, if any, have been addressed from the on-site audit.

Step 8

Surveillance visits are performed at least once a year but may be more frequent, depending on the size of your company.

Notes: An informal (but chargeable) pre-audit visit may be requested to determine readiness for formal assessment.

NB: Where required national taxes will be applied e.g. UK VAT @ rate applicable.
In some cases local travel and accommodation expenses will be levied e.g. USA.