From May 19-20, 2011 the 4th European GMP Conference was held in Heidelberg. The Conference attracted delegates from 25 different countries. The conference was booked up!
Speakers from US FDA, China FDA, WHO as well as from EU Authorities (UK, Germany, France) and industry colleagues discussed major GMP developments in 5 Sessions:
In the following some highlights of this major event are summarised:
The opening presentation was provided by Julie Maréchal-Jamil from the Brussels based European Generic medicines Association (EGA). The presentation informed about the comprehensive consequences from the new Directive on Falsified Medicine. The changes include among others:
The Falsified medicines Directive, when it is officially published, will define the framework to tackle the entry in the legal supply chain of falsified medicines or APIs. A number of aspects in the Directive will need further clarification during the implementation phase. The implementation process will be multifaceted. So called "Delegated Acts" and "Implementing Measures" will be used for the first time, replacing the former Comitology procedure. For example a Delegated Act will be needed to define the detail requirements regarding safety features (track & trace) or for API GMP principles. An example for the implementing measures is the establishment of the EC list of equivalent countries (equivalent GMP standards and supervision).
In addition a number of new Guidelines and procedures will be published in the months to come - as for example:
- GMP for Excipients (risk-assessment principles): With regard to GMP for Excipients the Directive requires that the manufacturer of the medicinal product will have to perform a "formalised risk-assessment which includes "source, intended use and previous instances of quality defects".
- GDP for APIs
By means of this Directive, the QP declaration will formally become a legal part of the marketing authorisation application, and the QP will be required to include a reference to the date of the audit.
For the first time a speaker of the Chinese State Food and Drug Administration (SFDA) gave a presentation at the European GMP Conference. Dr Yi-Ni Ye informed the audience about the revised Chinese GMP Guide which became effective on 1 March this year. According to the legal provisions there will be a transition period for existing pharmaceutical enterprises. However, new facilities as well as facilities with major reconstructions or expansions already need to fulfil the requirements since 1 March 2011. Dr Yi-Ni Ye explained that major GMP failures caused a number of tragic events in China.
The regulators in China identified a number of topics in the 1998 version which have not been addressed at all or in the necessary details - as, e.g., ongoing stability and cleaning of equipment.
The new GMP Guide is structured in 14 chapters and 313 articles:
Chapter 1 General Provisions
Chapter 2 Quality Management
Chapter 3 Organization & Personnel
Chapter 4 Building & Facilities
Chapter 5 Equipment
Chapter 6 Materials & Products
Chapter 7 Confirmation & Validation
Chapter 8 Documentation
Chapter 9 Production
Chapter 10 Quality control & Quality Assurance
Chapter 11 Contract Manufacture & Analysis
Chapter 12 Product Distribution & Recall
Chapter 13 Self Inspection
Chapter 14 Miscellaneous
In addition 5 Annexes have been published:
Annex 1 Sterile Medicinal Products
Annex 2 API
Annex 3 Biological Medicinal Products
Annex 4 Products derived from Human Blood
Annex 5 Herbal Medicinal Products
In general the new GMP Guide has strengthened management responsibilities and defined the responsibility of key personnel in more detail. The new China GMP Guide defined the Qualified Person, the Person in Charge of the Enterprise, the Heads of Production and the Heads of Quality Control as key personnel.
It is remarkable that the concept of the Qualified Person, which is a fundamental part of the EU GMP Guide, has been transferred to the Chinese GMP version (although there are some differences in the details between the EU und Chinese version).
Currently the SFDA only issues GMP certificates for facilities that manufacture medicinal products for the domestic market. The new EU Pharma Directive requires a written confirmation from API exporting 3rd countries. In order to import APIs from China to Europe the SFDA will need to implement a formal procedure in order to issues this confirmation. Considering the number of production sites in the API sector this will be a major challenge for the SFDA in the future.
Further details about other highlight presentations (Risk Assessment/Process Validation/Inspection Trends) as well as a detailed article about the new Pharma Directive will be published in further GMP News soon.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)