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GMP confirmation

Service is provided only in Ukraine.

We advise, carry out examination of documents,   organize process and  represent interests of the customer in regulatory bodies.

The GMP standard is a system of norms, rules and instructions concerning production of  medicines, medical devices, products of diagnostic appointment, food, food supplements  and active ingredients. Unlike quality control procedure by research of selective samples of the products which provides suitability to use of only these samples (and, probably, the batches  made in time next to the analyzed ones), the GMP standard reflects complete approach and regulates and estimates actually parameters of production and laboratory check.

All medicines, presented   in the territory of Ukraine have to have the certificate of GMP issued / verified  by State Inspectorate for Quality Control of Medicines of Ukraine.

GMP is required for all production sites (including contract manufacturing), involved in process of production of ready medicine.

The procedure of carrying out the compliance confirmation of production conditions  of medicines to requirements of GMP is approved by the order MZ of Ukraine No. 1130 of 27.12.2012.

The conclusion is issued for the  validity period of the GMP certificate of the producer.

The confirmation procedure of the GMP certificate of producers from PIC/S member countries takes place according to the simplified scheme (without expert commission departure to the plant of producer)

Member countries of PIC/S (Pharmaceutical Inspection Cooperation Scheme) are: Argentina, Australia, Austria, Belgium, Great Britain, Hungary, Germany, Greece, Denmark, Israel, Ireland, Indonesia, Iceland, Spain, Italy, Canada, Cyprus, Latvia, Liechtenstein, Lithuania, Malaysia, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Slovenia, USA, Taiwan, Ukraine, Finland, France, Czech Republic, Sheytsariya, Sweden, Estonia, Republic of South Africa

For other producers (who`s GMP certificate is issued not by member of PIC/S) is obligatory departure of the Ukrainian inspectors to plant.

LIST OF DOCUMENTS:

  • Application firm;
  • Legalized copy  PIC/S or other GMP certificates,
  • Legalized copy of the Production license;
  • Legalized power of attorney on the name of ASAP Group for representation of interests of your company  in government bodies
  • Site Master file
  • The report on the last inspection on production site
  • Copy of the registration certificate of medicines in Ukraine
  • Information about produced medicines on the site

Contact information

Anna Yabluchanskaya, MD, MPH
+38 095 122 00 99
Irina Derevianko, MD, PhD
+38 067 401 25 27
info@asapgroup.com.ua