Revised Annex 1 GMP for sterile products

Описание: About the Webinar
The manufacturing of sterile pharmaceutical products has always offered some challenges to regulators and industry alike. Ensuring appropriate quality and assuring sterility are two important aspects to be considered in the production and control of sterile products. The administration of a contaminated product to patients could have dire consequences.
Traditionally, regulatory bodies have primarily enforced their own GMP guidelines for the production and control of sterile products. Due to the differences in approaches, requirements and interpretation of these standards, compliance was often an issue for some manufacturers supplying their products to different countries/markets. Manufacturers exporting products to the USA, the European Union, PIC/S members and WHO member states had to consider the different requirements for the intended markets.
As part of the global harmonization process of norms and standards (e.g. Pharmacopoeia monographs and GxP texts), a working group was established to revise EU Annex 1. The revision was done over several years and the process included representatives from the USA FDA, EU, WHO and PIC/S. The intention was to have a harmonized GMP text for the manufacture of sterile products that will be adopted by all participating parties. The working group met several times and a number of consultations were held with industry and interested parties. Over the years, more than 6000 comments were considered and discussed.
In this webinar, some of the newer additions to the guideline for sterile products, including the sections on water and HVAC will be highlighted. Other areas in Annex 1 V15 cover Quality Risk Management, the need for a contamination control strategy (CCS) as well as sections on for example barrier technology and lyophylization.

Dr. AJ van Zyl (known as Andre) completed his B. Pharm., M. Pharm and two Ph. D. degrees in Pharmacy in South Africa.

He was trained as an inspector by USA FDA; PIC/S workshops; and he is certified as a Lead Auditor: ISO 14001:2015 (BSI).

He worked in various areas of pharmacy including academic hospital pharmacy, sterile product manufacture, clinical research, and drug regulatory affairs. He was Head of Inspections at MCC South Africa and the first Manager in the World Health Organization (WHO) Prequalification Program.

He is a member of the WHO Expert Committee and author of several of the WHO GMP guidelines.

He has performed various GMP, GLP and GCP inspections and audits as well as consultancies and training in many countries over the last 30 years.

His Facebook pages Van Zyl GMP Discussion and Van Zyl GMP International have a combined following of over 40 000 members.