GMP Conformity: A Ukrainian Perspective

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GMP Conformity: A Ukrainian Perspective

Сообщение News » 08 дек 2014 22:17

GMP Conformity: A Ukrainian Perspective

Pharmaceutical Technology europe

Lana Sinichkina is partner and head of Life Sciences and Healthcare
Practice, and Leonid Cherniavskyi is an associate, both at Arzinger Law Office,

GMP standards play an increasingly crucial role in ensuring the quality of medicinal products in
Ukraine, but they also have substantial impact on operations of foreign pharmaceutical companies.
The pharmaceutical market of Ukraine is rapidly developing in the light of a recently signed
Association Agreement with the European Union and plan of actions regarding European integration
approved by the government. Harmonisation of Ukrainian legislation in the field of pharmaceutical
manufacturing began in 2003 and is led by the State Administration of Ukraine of Medicinal Products
(SAMP). Since then, the SAMP has been constantly implementing the EU requirements of good
manufacturing practice (GMP), good distribution practice (GDP), good storage practice (GSP) and
harmonised procedures of inspection of medicinal products. GMP and GDP inspectorates successfully
operate within the SAMP.
Continuing harmonisation with EU GMP standards
The implementation of GMP standards plays an ever growing role in ensuring the quality of medicinal
products in Ukraine but also impacts operations of foreign pharmaceutical companies. On 16 July
2014 the Ministry of Healthcare of Ukraine (MoH) approved the new edition of the Good Manufacturing
Practice Standards (UA-GMP), which is mostly a Ukrainian translation of the EU Guidelines for Good
Manufacturing Practice for Medicinal Products for Human and Veterinary Use. The changes of the new
edition correspond with the respective changes in the EU guidelines, which became effective on 16 Feb.
2014, and concern mainly the section “Definition of Terms” and Section 2 “Personnel” of Part I (1).
The amendments were made following the needs of Ukrainian pharmaceutical industry and took
into account the definitions of terms used in the International Conference on Harmonisation (ICH) Q10
Pharmaceutical Quality System (2). Some of the updates and amendments are listed in the following.
• To the general wording that the “manufacturer should have an adequate number of personnel
with the necessary qualifications and practical experience,” the MoH added clarification that
the ultimate responsibility for an effective quality management system and achievement of quality
objectives is borne by the senior management of the company.
• The new edition (3) of UA-GMP clarifies situations when, despite the ban on unexplained overlaps in
personnel responsibilities, certain functions may be shared between the head of quality control
and head of production and/or the head of quality assurance or head of the quality unit depending on
the size and structure of the company. Such shared responsibilities relating to quality may include in
particular the design, effective implementation, monitoring and maintenance of the quality
management system.
• The qualified person may now be relieved from performing actions for ensuring that each
production batch imported from outside of Ukraine has undergone, in Ukraine, a full qualitative
analysis, a quantitative analysis of at least all the active substances and all the other tests or checks
necessary to ensure the quality of medicinal products in accordance with the requirements of
the marketing authorisation (4). Such exception may be allowed “in cases stipulated in Ukrainian
legislation (inter alia, where importation is made from another state with which Ukraine concluded
an international treaty on measures concerning compliance by medicinal products manufacturers
with GMP standards that are equivalent with the provisions of UA-GMP and provided that necessary
control measures were applied in the exporting country).” The new edition of UA-GMP requires that
a qualified person meet the criteria established in
Ukrainian legislation (5).
• Two more responsibilities were added to the list of recommended responsibilities of the heads of
production, quality control and, where relevant, the head of quality assurance or head of quality
unit: participation in management reviews of process performance, product quality, and of
the quality management system; advocating continual improvement; and ensuring that
a timely and effective communication and escalation process exists to raise
quality issues to the appropriate levels of management (6).
• The new subsection regarding external consultants was
introduced, requiring that such consultants should have adequate
education, training and experience, or any combination thereof, and
that records should be maintained stating the name, address,
qualifications and type of service provided by them (7).
Why foreign manufacturers need to prove conformity
with UA-GMP standards The Procedure on Conducting
Certification of Medicinal Products Manufacture (Compliance
Confirmation Procedure) concerning compliance with UA-GMP Standards
was approved by the MoH back in 2002 and is applied on a voluntary
basis. Although its new edition (entered into force in February
2013) still stipulates that procedure of confirmation of compliance
with UA-GMP standards is applied upon manufacturer’s will, in 2011,
amendments were introduced to the Law of Ukraine “On Medicinal
Products” (Law on Medicines), which required that companies obtain
the document confirming such compliance.
In the end of 2011, the Law on Medicines was complemented with
a new requirement to the procedure of obtaining marketing authorisation
for medicinal products. According to this amendment, the application
for marketing authorisation had to be supported, inter alia, with the
document issued by the SAMP, which confirms that the product
is produced at manufacturing facilities that comply with UA-GMP
requirements. It should be noted that such requirement referred only
to products produced by foreign manufacturers due to the fact that
manufacturing license of local Ukrainian producers was considered
to confirm the required compliance.
Furthermore, on 1 Jan. 2013, the requirement to provide the
mentioned document confirming compliance of manufacturing
conditions with UA-GMP standards was implemented to the procedure
of state quality control for imported medicinal products. This resulted in a
ban on import of medicinal products in cases when such document could
not be provided.
Companies that could not obtain the necessary GMP confirmation
from the SAMP for any reason (either did not meet the deadlines or did
not pass the SAMP inspection) were unable to import their products to
Ukraine until they managed to obtain the necessary confirmation, or in
case of failure to obtain one, started considering transfer of production to
other manufacturing sites including local contract manufacturing. There
are several examples in 2013–2014 of companies deciding to choose
the second option in cases when their manufacturers failed to obtain
Ukrainian GMP approval. Such companies, however, faced and
continue to face substantial gaps in sales of products in Ukraine (which
may have been successful before the ban) because they had not taken
timely measures to prepare for the new requirements to UA-GMP
compliance confirmation.
Future amendments in UA-GMP and procedure for conformity confirmation
As of today, there is a working group established under the auspices
of the SAMP that is dedicated to developing GMP-related legislation.
On 10 Sept. 2014, the SAMP published the draft of the amended procedure
for obtaining the document, which confirms compliance with UA-GMP
requirements. The proposed amendments mostly concern
the procedure of inspection of manufacturing facilities, order of
adopting the decision to grant the relevant UA-GMP confirmation
document by the SAMP, as well as matters of controlling compliance
with UA-GMP requirements during the term of validity of the named
document. The draft also provides for extension of the terms of certain
stages of inspection, leading to extension of the total time needed
to obtain the relevant confirmation document. Another new requirement
is that only a Ukrainian resident may represent a foreign company during
the procedure of confirmation of UA-GMP compliance before the SAMP.
Following the developments in Ukrainian GMP standards and
compliance, confirmation procedures are important for pharmaceutical
companies supplying their products to Ukraine. Failure to adapt
manufacturing facilities or to timely get the necessary documents from
regulatory authorities may lead to an inability to obtain marketing
authorisation for a new drug or to import medicinal products harming
the reputation and revenues of the company in Ukraine.
1. Part I, Guideline “Medicinal Products. Good Manufacturing Practices,” approved by the order of the MoH No. 497 dated 16 July 2014.
2. ICH, Q10 Pharmaceutical Quality System, Step 4 version (June 2008).
3. Paragraph 2.1–2.4 “General Requirements” of Part I, Guideline “Medicinal Products. Good Manufacturing Practices.”
4. Paragraph 2.5 of Part I, Guideline “Medicinal Products. Good Manufacturing Practices.”
5. Paragraph 2.6 of Part I, Guideline “Medicinal Products. Good Manufacturing Practices.”
6. Paragraph 2.9 of Part I, Guideline “Medicinal Products. Good Manufacturing Practices.”
7. Paragraph 2.23 of Part I, Guideline “Medicinal Products. Good Manufacturing Practices.” PTE


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