GMP: Keeping in Step with the EU

The State Service of Ukraine on Medical Products has announced the coming into force of the Guidelines СТ-Н of the MHU 42 4.0:2015 "Medicines. Good Manufacturing Practice" approved by the Order of the Ministry of Health of Ukraine No.478 "On Amendments to the Order of the Ministry of Health of Ukraine No.95 dated 16 February 2009" issued on 30 July 2015.

The amendments to certain sections of the document «The Rules Gover­ning Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use» came into force in September/October 2014 and in March 2015. Accordingly, there arose the need for revision of Guidelines on GMP applicable in Ukraine in view of the requirement to harmonize the Ukrainian legislation with the corresponding EU law.

Therefore, compared with the previous version, the following sections of the Guidelines were revised:

• Section 3 part 1 of the Guidelines "Premise and Equipment";
• Section 5 part 1 of the Guidelines "Production";
• Section 6 part 1 of the Guidelines "Quality Control";
• Section 8 part 1 of the Guidelines "Complaints,Defects of Quality and Product Recall";
• Section 2 "Basic Requirements for Active Substances Used as Starting Materials";
• Section "Normative References" was supplemented by bibliographic description of two draft guidelines on GMP and GDP issued by the European Commission.

Please note that the Guidelines are comprised of three chapters and nineteen supplements. Chapter I sets out the GMP principles for manufacture of medicines. Chapter II covers the GMP principles for manufacture of active substances used as starting materials. Chapter III contains the list of normative documents which define the requirements for Site Master File, quality risk management (ICH Q9), pharmaceutical quality system( ICH Q10) and internationally harmonized requirements for certification series.