New EU (European Union) GMP (Good Manufacturing Practice) Annex 1 and its Impact on Pharmaceutical Manufacturers Training Course

Latest changes in the manufacturing requirements for sterile medicinal products

This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

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Recorded on 8 June 2023

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Format: Recorded webcast
CPD: 1.5 hours for your records
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Overview

The requirements of Annex 1, (which came into effect in August 2022), are applicable to the production of sterile pharmaceutical products. Manufacturers were given one year to adapt to the new guidelines, except for a part related to Lyophilization, where an additional year has been allowed to meet the Lyophilization criteria.

Since Annex 1 was first published, there have been numerous changes in technology, authority and patient expectations in GMP regulations.

A key element of Annex 1 is Contamination Control Strategy (CCS). Although this was presented as a new requirement, in fact contamination and cross-contamination were already mandatory requirements in facilities producing sterile medicinal products. The objective here is to include the measures taken by the manufacturing facility in a master document, which can be used periodically by senior management to ensure their facility meets the safety requirements.

Annex 1 refers to the importance of fulfilling the requirements set forth in ICH Q9 regarding Quality Risk Management. Interestingly, ICH completed the revision of Q9 in January 2023 and finally released it after 18 years of discussions.

Both sterile medical product manufacturers and the regulatory authorities emphasize the importance of evaluating the new Annex 1 according to the ICH Q9 guideline.

This webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be discussed will include how to prepare your CCS document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.

This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.

Benefits of Attending

By participating in this webinar, you will receive detailed information about the new Annex 1, be brought up-to-date regarding the requirements, and the webinar documents will be a useful reference source for the future.

This is a 90-minute free event, book your place now!

Who should attend?

Sterile Medicinal Product Manufacturers in the following departments:
Quality Assurance
Quality Control
Manufacturing
Aseptic Filling
Regulatory Affairs
IT

This webinar will also be of interest to:

Regulatory Authority Inspectors / Auditors
Pharmacy, chemistry, engineering students and new graduates

The New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers course will cover:

Brief history of Annex 1
Why was revision needed to Annex 1?
What are the expectations?
Which path should you follow for preparing the Contamination Control Strategy main document?
How should you adapt to the principles of Quality Risk Management?
Q&A - Discussion

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.

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