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Main  >  News  >  Seminar “Prospective changes in GMP requirements for the production of sterile drugs”

Seminar “Prospective changes in GMP requirements for the production of sterile drugs”

02/17/2020 | GILS and NP, GMP practices

On March 12-13, 2020, FBI GILS and NP and PHARMSTRATEGIA, as part of a joint program to promote best practices in the Russian pharmaceutical industry, conduct an open expert consultation and training seminar (advanced training program with the issuance of established certificates) on the topic " Prospective changes in GMP requirements for the production of sterile drugs. Modern approaches and regulatory expectations. Draft Appendix No. 1 GMP EC of 12.20.2017. Practical aspects of ITF implementation. ”

The technological development of the pharmaceutical industry necessitates a change in regulatory requirements. This is true for the most strictly standardized sphere - the production of sterile medicines. Transition to the Eurasian GMP rules, approval of the draft Guidelines for aseptic processes, the new Appendix 1 of the EU GMP Guidelines affect all aspects of production and the various functions of manufacturers. In addition, ongoing changes must be considered by suppliers when supplying new equipment or installing new production facilities.

At the seminar, participants will be able to:

• Understand changes in requirements in connection with the transition to Eurasian GMP rules and the approval of the draft Guidelines for aseptic processes;
• Understand the impact of the new Annex 1 of the EU GMP Guidelines on the future of sterile manufacturing processes;
• outline for themselves an effective strategy of action within the framework of modern GMP approaches in order to ensure that the production of sterile drugs meets the prospective regulatory requirements.

The seminar will consider:

• analysis of current practice and changes in regulatory expectations in connection with the transition to the GMP Eurasian rules;
• application of a risk-based approach in the production of sterile products in order to reduce the risk of contamination and maintain the quality of medicines;
• requirements and practical aspects of the qualification of autoclaves in the framework of modern GMP approaches;
• requirements and regulatory expectations as part of process modeling using a growth medium (ITF).

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