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Modern Approach to Conducting GMP-Compliance Audits 


by Elena Tsukgieva and Oleg Spitsky, Biopharmproject LLC


     Since the enforcement in 2014 of Russian GMP Rules (Rules for Organisation of Medicinal Products Manufacturing and Quality Control) by the Order #916 of the RF Ministry of Industry and Trade dated June 14, 2013, most of the medicinal products’ manufacturers   acting on the territory of the Russian Federation have faced the need in proceeding with independent GMP compliance assessment of their production facilities.

     According to the Federal Law #61-FZ “On Circulation of Medicinal Products”, compliance with the above-mentioned Russian GMP Rules is prerequisite for producing medicinal products and  as well as for obtaining positive conclusion as a result of the manufacturing facility GMP-inspection being carried out by the authorized Russian federal executive body.


     Despite the fact that a number of Russian pharmaceutical companies formally comply with the GMP Rules to this or that extent, there are still a lot of issues in the GMP-compliance area that cannot be solved under their own resources due to lack of appropriate personnel, competencies, time etc. Authority’s GMP inspections cannot be considered of any help in solving those issues because of being aimed only to determine formal compliance or incompliance of a manufacturing facility and not to develop the measures essential to achieve the required level of GMP compliance.  In that connection under this new stage of preparation to such planned authority’s GMP inspections a certain preliminary assessment of the manufacturing facility compliance status is required as well as assistance in achieving GMP-compliance.

     The most widespread and optimal way of solving such tasks is having preliminary audits for GMP compliance being conducted by qualified specialists. Such audits are widely used in international practice.


     The most important advantage of the preliminary compliance audits compared to the inspections is that the company gеts a chance to better study and assessment of its achievements and drawbacks in the GMP-compliance area as well as adding value help and consultations from the auditors regarding the development of essential measures to be implemented to achieve the GMP-compliance.

     Since the first GMP Rules were adopted in Russia (authentic to the European GMP Rules) in the form of the national standard GOST R 52249-2004, the GMP requirements have significantly evolved, which is supported by an introduction of ICH Q10 (Pharmaceutical Quality System) requirements into Chapter 1 of the Rules. The Pharmaceutical Quality System indicated in the GMP Rules combines the principles of quality assurance (according to GMP) and quality management (according to ISO 9001) and has fundamental differences from the previous separate systems, which propels it to the next level. Compared to the GMP quality assurance system, the Pharmaceutical Quality System includes such important regulations from the quality management system as participation of top managers in quality management and continuous improvement of the system. At the same time the main goal in both the Pharmaceutical Quality System and the GMP Rules is not just achieving customer satisfaction but quality assurance of medicines as the finished products in terms of quality, safety and effectiveness for the patients.

Evolving of the Pharmaceutical Quality System has also significantly influenced the development and change of approaches to conducting GMP-compliance audits. Earlier, during an audit of the quality assurance system according to GMP requirements and quality management system according to ISO 9001 requirements mainly the formal compliance of the system was checked, i.e. compliance with the requirements of standards, contract provisions, activities planned within the framework of system operation, etc. Now, an auditor is no longer a formal inspector but also a subject of the Pharmaceutical Quality System, who apart from the traditional assessment also assists the company:

  • to assess the effectiveness of the System in forming and achieving a proper strategy of product quality management;
  • to define and assess the critical factors influencing the quality as well as the required activities to reduce the quality risks they might present;
  • to contribute to a continuous improvement of the Pharmaceutical Quality System of the company;
  • to contribute to the effective and efficient business performance of the company.


     In this connection the most critical issue for conducting of any compliance assessment is the qualification of auditors’ team, whether it pertains to the first, second or third party audit. It means that the team of auditors carrying out the assessment of the Pharmaceutical Quality System must: firstly, have special competences, professional knowledge and skills in various areas of pharmaceutical quality and GMP compliance; secondly, know and understand the general principles and tools of quality management; and, thirdly, have a documentary confirmation of the compliance to the above qualification requirements.

     One of the most reputable international organizations conducting the inspection and confirming the compliance of the different management systems auditors to the applied qualification requirements is the International Register of Certificated Auditors (IRCA).

The fields of certification and training of the auditors in IRCA include not only the most widespread basic standards of the management systems according to ISO, such as quality and environmental management systems, but also the management systems of industrial sectors and technical areas such as power engineering, IT, marine safety, pharmaceutical quality, etc.


     In 2014 a group of our specialists from the Quality and Validation Department and Process Department, was trained at the IRCA accredited course “Auditor/Lead Auditor of the Pharmaceutical Quality System” conducted by the trainers from Great Britain and passed a 2-hour written qualification examination. As a result of this training, the specialists, received IRCA certificates confirming a successful pass of the examination and compliance with the qualification requirements applied to the auditors/lead auditors of the Pharmaceutical Quality Systems.

     Therewith, based on signed partnership agreement with NNE Pharmaplan, Denmark it may be possible to engage international experts to audit.

That is why at present Biopharmproject in Russia has all the necessary resources and competences that allow us to gather a team of highly professional auditors at short notice, who will help our clients to not only formally define the level of compliance but also to provide recommendations and develop a package of measures and activities to be implemented for the continuous improvement of Pharmaceutical Quality System. These activities will allow the company not only to achieve GMP compliance but also to define and formulate strategic management objectives contributing to effective business development.

The assessment of compliance can be carried out in the following areas:

  • conducting a preliminary GMP compliance audit and/or gap-assessment of a company within the framework of preparation to an inspection by the Russian regulatory authorities;
  • GMP-compliance audits of the contract manufacturing organisations (CMOs);
  • audits within the framework of implementation company’s internal audits programme (self-inspections);
  • critical suppliers quality audits (as part of suppliers qualification and assessment processes);
  • development and implementation of an action plan required for achieving GMP- compliance and efficient performance of the Pharmaceutical Quality System.


If you are interested in Biopharmproject GMP-compliance services, please contact us.