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GMP News No. 488
10 November 2004
On 20-22 October among others, speakers from FDA and EMEA gave presentations on hot GMP and Regulatory Affairs Topics. More than 200 participants and 20 speakers joined the 7th European Conference on APIs presented by APIC/CEFIC and organised by CONCEPT HEIDELBERG in Lisbon.
Dr Moheb Nasr, FDA Director of the Office of New Drug Chemistry gave the first presentation. His talk was about the initiative "Pharmaceutical Quality of the 21st Century". At the beginning he stressed that the initiative is not intended to reduce the regulatory requirements but to have a strong public health protection. In order to achieve this FDA has defined specific objectives:
As part of the Risk-based Management Plan, Dr Nasr explained the risk-based model for inspectional oversight that has been published recently (September 29) in a White Paper.
The FDA Inspection will be planned on the basis of 3 key elements.
If the company has a "clear record" they will face less inspections.
Not only how complex the dosage is, but also the capacity of a manufacturing site will have an influence on the frequency of inspections (e.g. if a great output of large volume parenterals is produced, the site will be inspected more often than a site with only a small output). Of course, also the dosage form itself will have an influence (e.g. parenterals have a higher risk than solid dosage forms).
"It doesn't really matter how complex the process is." The new approach is more based on the amount of information you have about your process and how you are able to control the process (e.g. by using state-of-the-art technology like PAT).
In the following, Dr Nasr stressed the importance of international collaborations. FDA will actively involve in ICH Q8 and Q9 and help to build up a group that will set up Q10.
The FDA has also decided to become a member of PIC/S. This will help FDA to deal with the limited resources.
Under the leadership of the Council on Pharmaceutical Quality the following activities are planned:
Dr Nasr stressed that the famous 3 batches for process validation are no longer a proof that the company understands the process.
In addition, he mentioned the following activities under the leadership of the Council on Pharmaceutical Quality.
Dr Nasr emphasised that FDA undergoes a "cultural change". The review practice and also the organisation of this activity will be very much influenced by this change. With regard to the CMC specification, Dr Nasr mentioned that they should be based on
Dr Katrin Nodop from the European Medicines Agency (formerly called European Medicines Evaluation Agency) gave a presentation about the new pharmaceutical legislation in Europe. As a result of this review, the following regulations and directives have been set up:
Regulation replacing current Regulation 2309/93/EEC
-> Reg. 726/2004
Two of the main changes with GMP consequences are:
Dr Nodop emphasised that the review has not defined that API manufacturers have to be inspected by a European authority. But it has been defined in "Title IV: Manufacture and Importation, Human Art. 46(f) and veterinary Art.50(f), Chapter 1":
The holder of a manufacturing authorisation is obliged to comply with the principles and guidelines of GMP for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials.
As the ICH Q7A Guide on GMP for APIs (in Europe Annex 18 of the EU GMP Guide) will be the relevant guide, there is a need for a review of Annex 18. The reasons are:
In "Title IV: Manufacture and Importation, Human Art. 46(f)" it is mentioned that
Currently the Commission is evaluating which excipients will be covered by this requirement. A questionnaire was published recently.
Although there is no legal obligation for the competent authority to carry out inspections, it is clearly stated in "Title XI: Supervision and Sanctions Human Art. 111(1) and veterinary Art. 80(1)" that
and in "Human Art. 111(5) and veterinary Art. 80(5)" that
In the future, a Community database for GMP will be set up. The proceeding for the GMP database will be:
For the first time, also negative information (e.g. a site is not GMP-compliant) will be put into the new database. The new database features can be identified in the following graphics:
As future activities for EMEA in the field of GMP for APIs and excipients, Dr Nodop mentioned:
According to the time table the implementation of these new provisions have to be finalised until 30 October 2005. And, industry has to implement the new provisions as well.
In addition to these two presentations, many authority and industry presentations were given on current GMP and Regulatory Affairs topics.
APIC/CEFIC and CONCEPT HEIDELBERG would like to thank the exhibitors:
They would like to express special thanks to Hovione for acting as sponsor of the Social Event. All participants and speakers appreciated the sight-seeing tour, the visit to the museum and the excellent dinner afterwards.
The 8th APIC/CEFIC Conference on Active Pharmaceutical Ingredients will be organised in 2005. For more information send us an e-mail: info (at) concept-heidelberg (dot) de.