With support:
Ministry of Industry and Trade Eurasian Economic Union FSI «SID & GP» SKOPINFARM LTD.

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Professional development course
Current aspects of good manufacturing practice
Duration:

72 ac. hours

Terms of study:

3 weeks

Cost of education:

Clarify ₽

Course information:
Training start date of the nearest stream -

If you send a group of 3 or more trainees for training, we are ready to provide you with a partner price offer.
For more information please call +7 (495) 676-43-12
Course content:

  • State system of regulation of the circulation of medicines

    Introductory lecture. Basic principles of GMP

    Medicinal product as an object of regulation and a subject of regulatory science

    Preparation of modules 2.3 and 3 of the registration dossier

    Practical training
  • Pharmaceutical quality system in the manufacture of medicines

    Pharmaceutical quality system within the requirements of the ICH Q10 document. Quality management system within the framework of Chapter 1 GMP
  • GMP requirements for personnel

    GMP: Personnel. GMP requirements for personnel and authorized person. Role, rights and responsibilities of authorized persons of pharmaceutical manufacturers
  • GMP requirements for premises, equipment and engineering systems at pharmaceutical production facilities

    Basic GMP requirements for production systems (premises, equipment, engineering systems)

    Application of GMP requirements at the life cycle stages of production sites, clean areas and facilities

    Practical training
  • GMP requirements to the technological process of production of sterile and non-sterile medicines

    Technological process. General requirements. Production and packaging

    Technological process. General requirements. Production and packagingGeneral requirements for the production of sterile medicinal products. Production of medicinal products subjected to finishing sterilization. Types of sterilization

    GMP requirements for the production of medicines in aseptic conditions. Validation of aseptic processes
  • GMP requirements for documentation at pharmaceutical manufacturing

    General GMP requirements for documentation in pharmaceutical manufacturing. Changes in GMP requirements to the documentation system

    Series dossier within the framework of GMP requirements. The main dossier of the production site. Modern requirements for design and content
  • Production of pharmaceutical substances according to GMP requirements

    Basic GMP requirements for the production of substances (overview) Requirements for personnel. Buildings and premises, process equipment in the manufacture of substances. Documentation and protocols
Categories of trainees:

  • Inspectors/auditors (prospective and/or current)
  • Employees of pharmaceutical manufacturers
  • Employees of industry departments and organizations
The professional development program is developed in accordance with the following documents:

  • Federal Law of April 12, 2010 N 61-FZ "On Circulation of Medicines" (updated on 29.06.2021)
  • Federal Law of May 4, 2011 N 99-FZ "On licensing of certain types of activities" (updated on 16.12.2021)
  • Resolution of the Government of the Russian Federation No. 686 dated July 6, 2012 "On Approval of the Regulations on Licensing the Manufacture of Medicines" (updated on 11.01.2021)
  • Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 77 "On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union"
  • Order of the Ministry of Industry and Trade of the Russian Federation of June 14, 2013 N 916 on approval of the rules of good manufacturing practice
  • State Pharmacopoeia of the Russian Federation (XIV edition)
  • Federal Law "On Education in the Russian Federation" of 29.12.2012 N 273-FZ (latest edition)
Minimum requirements for trainees (any of the following):

Higher or secondary professional education

Scope of the program:

72 academic hours

Form of training:

Part-time with the use of distance education technologies

Terms of training under the program:

3 weeks


Document to be issued:

Upon graduation, according to Federal Law 273-FZ "On Education in the Russian Federation", students are issued certificate of professional development of the established sample.

Presentation of the certificate:

The certificate can be presented to the listener personally, for this you must first to enroll by contacting the Academy by phone or e-mail.


If there is no possibility of personal receipt, the certificate will be sent by the delivery service documents with a tracking number assigned (delivery is free).

Contact information: E-mail: info@gxp-academy.org Phone: +7 (495) 676-43-12

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Current aspects of good manufacturing practice


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