The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Center of good engineering practice

Expert support in the field of Good Engineering Practices (GEP) throughout the life cycle of a production or project.

The first state Center of Good Engineering Practices of the Federal Budgetary Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade (hereinafter FBI SID and GP) was established with the aim of forming the branch system of Good Engineering Practices consistent with international standards and uniting bona fide participants of the market.

The key objective of the Center is expert support of the enterprise and the search for optimal mechanisms for compliance with the requirements of normative documentation, taking into account the interests of both producers and consumers.

The Center for Good Engineering Practices employs qualified experts with the necessary knowledge and competence to conduct works at the highest professional level.

PRESENTATION OF INTERESTS OF THE CUSTOMER IN THE PROCESS OF:
DESIGNING THE ENTERPRISE
  • Qualification of Terms of Reference
  • Qualification of the conceptual project
  • Design qualification
  • Qualification of the working documentation
CONSTRUCTION/RECONSTRUCTION OF THE ENTERPRISE
  • Maintenance of reconstruction and construction projects for pharmaceutical enterprises and local production sites, performing expert support functions for the Customer
  • Audit of CMP
  • Expert supervision in the field of compliance with GMP
  • Installation qualification IQ
  • Designer’s supervision
PUTTING THE ENTERPRISE IN OPERATION
  • Qualification of clean rooms
  • Qualification of the water treatment systems
  • Qualification of the water treatment system
  • Qualification of systems for preparation and distribution of process gases
  • Qualification of technological equipment
OPERATION
  • Drawing up a Validation Master Plan
  • Validation of analytical procedures
  • Validation of manufacturing process
  • Qualification of computerized systems
  • Validation of cleaning process
All experts have practical experience working at leading domestic and foreign pharmaceutical enterprises at positions of higher engineering or managing staff, thus possessing practical skills in solving the daily problems faced by the manufacturer of medicinal products.

The Center for Good Engineering Practices includes the Clean Room Qualification Laboratory.

Availability of all necessary equipment in the laboratory and the experience of the employees of the center allow to conduct qualification of:

  • clean room grade;
  • integrity of the installed filters;
  • capacity reserves of the air handling system;
  • tightness of the enclosing structures;
  • compliance of the share of recirculation and outdoor air with the project;
  • modes for separating clean zones;
  • recovery time by pollution level;
  • stability of maintaining temperature and relative humidity;
  • illumination and noise levels;
  • speed of the air flows and the frequency of the air exchange;
  • completeness of the executive documentation.

According to GOST R ISO 14644-4-2002, the certification of clean rooms is carried out:

  • at the stage of a draft and working project,
  • at the stage of the constructed building,
  • at the stage of the equipment delivery,
  • at the stage of equipped premises and in the process of operation.

Based on the results of the tests, the specialists of FBI SID and GP prepare and pass to the customer a qualifying package of documents (plans, protocols, reports, conclusions, recommendations and terms of the next qualification) in accordance with the requirements of Russian legislation that can be used to develop corrective and preventive measures.

The Center for Good Engineering Practice invites industry experts from different functional areas of pharmaceutical activity (production, engineering services, quality control and quality assurance services, metrologists, etc.) to cooperate with the aim of:

  • Building a mechanism for qualitative interaction between the regulatory agency and the representatives of the industry;
  • formation of a common understanding of the philosophy of GEP;
  • joint development of guidelines and recommendations in the field of GEP, GMP and GDP.

You may get information about the GEP Center from the following presentations:

Good Engineering (PDF, 756 Кб)

Practice Department 2 (PDF, 508 Кб)

For information please contact:

Igor Falkovskiy
falkovskiy@gilsinp.ru

 +7 (495) 676 43 60 (ext. 237 or 401)