Maintenance of the procedure of confirmation of manufacturer’s GPM certificate compliance

Compliance of the conditions of medical product with the requirements of the appropriate medical practice (GPM) is the guarantee of compliance of control system with quality standards, respondent the product prescription, registration file requirements and specification. The order of confirmation of manufacturer’s conditions compliance with the manufacture’s GPM norms is regulated by the Order of MHC of Ukraine №1130 dated 27.12.12. Pursuant to the current legislation the confirmation of manufacture’s compliance with GPM norms for Ukrainian and foreign manufacturers is carried out by the State service of Ukraine on medical products and drug control (Gosleksluzhba (State medical service)) by means of holding documents expertise or documents expertise and inspection of manufacture.

Committee’s visit to the plant isn’t required for manufacturers, compliance with GPM norms acknowledged by an authorized body of the country-member PIC/S (international System of cooperation of pharmaceutical inspections). In such cases the procedure is simplified and is confined to the specified document package expertise with its issue as a result of Conclusion on the confirmation of compliance.

In other cases, the Certificate is the result of inspection, confirming the fact of compliance of manufacture’s conditions with GPM requirements.

The company 8L GROUP is ready to provide full maintenance of procedures for both cases.

The process of certification of manufacture with our maintenance includes the following stages:

1st stage	Primary consultation of the client on procedure.
2nd stage	Pre-expertise of the clients’ document package.
3rd stage	Formation of application on certificate issue + full document package for presentation at SMS.
4th stage	Presentation of document package to SMS.
5th stage	Expertise of document package by the specialists of GPM-center.
6th stage	Agreement formation with GPM-center on rendering inspection services for manufacture.
7th stage	Concordance of the terms of inspection. Receipt of the program of inspection.
8th stage	Receipt of the invoice for payment of inspection services of GPM center. Payment of services.
9th stage	Inspection of the manufacture of medical products at the place of activity.
10th stage	Acquaintance with the detailed results of inspection (in SMS report format)
11th stage	Meeting of the SMS committee with settlement of confirmation GPM norms compliance of manufacture’s conditions.
12th stage	Receipt of the project of Certificate of GPM requirements compliance in case of positive decision of the committee // reading of the document.
13th stage	Receipt of the original of Certificate of compliance with GPM requirements.
14th stage	Manufacturer’s presentation of a plan for remarks elimination as a result of inspection (if there are any).

In some cases the process includes inspection of laboratories, implementing quality control services, or storage zones of the companies, implementing storage service on the agreement.

The period of validity of the Certificate if 3 years, after this period it will be necessary to re-registrate it.

The procedure of confirmation of GPM certificate of manufacturers from countries-members of PIC/S includes the following stages:

1st stage	Primary consultation of the client on procedure.
2nd stage	Pre-expertise of the clients’ document package.
3rd stage	Formation of application on certificate issue + full document package for presentation at SMS.
4th stage	Expertise of document package by the specialists of SMS.
5th stage	Receipt//reading of the project of Conclusion of GPM compliance.
6th stage	Receipt of the original of Conclusion of GPM compliance.

The Conclusion is issued for the period of validity of manufacturer’s GPM certificate, after that the formation of confirmation for the updated certificated will be needed.

Please, contact us and we’ll help you to save your time and budgets for new projects and additional opportunities.