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:
- To encourage the early adoption of new technological advances by the pharmaceutical industry
- To facilitate industry application of modern quality management techniques
- To encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas
- To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science
- To enhance the consistency and coordination of FDA's drug quality regulatory programs especially review and inspection activities
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.
- The GMP History
If the company has a "clear
record" they will face less inspections.
- The Drug Product
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).
- The Manufacturing Process
"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:
- Develop additional guidance on quality systems for pharmaceutical manufacturing so that the Agency’s goals to enhance and modernize the regulation of pharmaceutical manufacturing and product quality is met
- Continue development of the risk-based pharmaceutical quality assessment system that will replace the current CMC review system to remove hurdles to continuous improvement following drug approval
- Revise the 1987 industry guideline on Process Validation to include 21st century concepts, including risk management and a life-cycle approach
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.
- Continue to explore and formalize risk-based tools to enhance FDA's regulatory oversight
- Refine the CGMPs and meet our harmonization (internal and international) goals
- Continue timely communication of our current thinking on various quality issues to the public to facilitate compliance with FDA requirements
- Further enhance FDA's own quality systems (including more mechanisms to facilitate communication within the Agency)
- Continue and expand on opportunities to integrate science-based policy and standards into our product quality regulatory approach
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
- Risk-based assessment
- Clinical relevance (performance and safety considerations)
- Process knowledge and understanding - not necessarily process capability and analytical method limitations!
- Knowledge gained from Pharmaceutical Development Reports (PDR)
- Better utilization of modern statistical methodologies
- These issues will be addressed at PQRI Workshop in March 2005
These issues will be addressed at PQRI Workshop in March 2005
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
Directive amending Directive 2001/83/EC ("Human code") -> Dir. 2004/27/EC
-> Dir.
2004/24/EC (Traditional Herbal Products)
Directive amending Directive 2001/82/EC ("Veterinary code") -> Dir. 2004/28/EC
Two of the main changes with GMP
consequences are:
- Inspection and control
- Databases - manufacturing authorisations,
GMP certificates, adverse reactions
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":
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In
addition to these two presentations, many authority and industry
presentations were given on current GMP and Regulatory Affairs topics.
