News Conference: “Implementation of EMA procedures and PIC / S guidances into Ukrainian legislation”
July 17, 2019
Kyiv, AKKO International Exhibition Center, 40B Peremohy Ave.,
the Shulyavskaya subway hall, Pushkin Park
Agenda
| 14:30 – 14:45 | Opening |
| 14:45 – 15:45 | Implementation of EMA procedures and PIC / S guidances into Ukrainian legislation - the draft order of the Ministry of Health of Ukraine “On approval of the Procedure for confirmation of production of medicinal products to the requirements of good manufacturing practice”. Natalia Takhtaulova Head of Department for Licensing of Production, Import of Medicines, Control of Compliance with Licensing Conditions and Certification of the State Service of Ukraine for Medicines and Drug Control. |
| 15:45 – 16:00 | Coffee break |
| 16:00 – 17:20 | Guidance on classification of GMP deficiencies PIC/S PI 040-1 |
| 17:20 – 17:30 | Answers to the questions |
The First International Pharmaceutical Congress, the conference “Implementation of EMA procedures and PIC / S guidances into Ukrainian legislation” was conducted on the 17th of September. The conference was organized by the State Enterprise "Ukrainian Pharmaceutical Institute of Quality" with the support of the State Service of Ukraine for Medicines and Drug Control (hereinafter - the State Service of Ukraine). During the event, the draft order of the Ministry of Health of Ukraine “On Approving Changes to the Procedure for Confirming the Conformity of the Production of Medicinal Products with the Requirements of Good Manufacturing Practice” was discussed (hereinafter - the Draft Procedure), as well as the issue of classification of deficiencies in terms of non-compliance with the requirements of good manufacturing practice according to the Guidance on classification of GMP deficiencies PIC/S PI 040-1.
Natalia Takhtaulova, Head of the Department of Licensing of Production, Import of Medicines, Control over Compliance with Licensing Conditions and Certification of the State Service, spoke about the provisions of the draft Order. She informed that the public discussion of the draft Order had already ended and during this period the State Service had received an appeal from the business entities both for its support, as well as comments, suggestions and reservations about it.
This draft document is intended to align with the requirements of the PIC / S and the European Community's collection of inspection and information exchange procedures of 03/10/2014 No.EMA / 572454 / 2014Rev 17 (Compilation of Community Procedures on Inspections and Exchange of Information) (hereinafter referred to as the Compilation Procedure) the terms "critical violation" and "material misconduct".
The classification of GMP observations was described by Denys Ostrovnoy. He noted that the classification of observations is a complex issue. The same observation can be classified as minor or major or critical it depends on the level of risk to the product quality and the patient. The risk depends on many factors that can increase or decrease it.
Denys Ostrovnoy informed that proposed changes in Ukrainian legislation are based on Guidance on classification of GMP deficiencies PIC/S PI 040-1 and a recommended model for risk-based inspection planning in the GMP environment PIC/S PI 037-1
Changes in Ukrainian legislation is intended to provide a tool to support the risk based classification of GMP deficiencies from inspections and to establish consistency amongst Inspectorates.
This guidance will enable Industry to be informed of the principles used to classify GMP deficiencies and also provide examples of the classification of different types of deficiencies. This approach is not binding as the classification
takes also into account the context of the finding and the quality history of the site.
Consistency of classification of GMP deficiencies will assist in the following:
a) Improve inter-agency consistency in reporting and facilitate communication between inspectorates;
b) Harmonise inspectorate response and management of deficiencies classified as “Critical”, “Major” and “Other”;
c) Provide transparency in how the deficiencies are classified;
d) Simplify international deficiency trend analysis based on harmonised reporting of GMP deficiencies from different inspectorates.
Definitions were harmonized with PIC/S Guideline also.
Critical Deficiency
A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal.
A “Critical” deficiency also occurs when it is observed that the manufacturer has engaged in fraud, misrepresentation or falsification of products or data.
A “Critical” deficiency may consist of several related deficiencies, none of which on its own may be “Critical”, but which may together represent a ”Critical” deficiency, or systems’ failure where a risk of harm was identified and should be explained and reported as such.
Major Deficiency
A deficiency that is not a “Critical” deficiency, but which:
- has produced or may produce a product which does not comply with its Marketing Authorisation, Clinical Trial Authorisation, product specification; pharmacopoeia requirements or dossier;
- does not ensure effective implementation of the required GMP control measures;
- indicates a major deviation from the terms of the manufacturing authorisation;
- indicates a failure to carry out satisfactory procedures for release of batches or (within PIC/S) failure of the authorised person to fulfil his/her duties;
- consists of several “Other” related deficiencies, none of which on its own may be “Major”, but which may together represent a “Major” deficiency or systems failure and should be explained and reported as such.
Other Deficiency
A deficiency that is not classified as either “Critical” or “Major”, but indicates a departure from Good Manufacturing Practice (GMP).
A deficiency may be judged as “Other” because there is insufficient information to classify it as “Critical” or “Major”.
Comment
One-off minor discrepancies are usually not formally considered deficiencies,
but are brought to the attention of the manufacturer as comments.
