European Commission to consider measures to strengthen the monitoring API - API, GMP inspections - the pharmaceutical industry
Counterfeit or substandard API May enter the supply chain of pharmaceutical products to the European Commission is considering a number of measures, on
API GMP production and make more stringent inspection requirements The integrity of the supply chain for the pharmaceutical industry is a vital issue. European Commission (EC) has recently recommended the implementation in Europe is more severe measures to combat counterfeit drugs, and these include the strict production requirements as well as the API supply chain.
March 2008, EC on the proposed anti- Fake Measures (to amend the appropriate laws and regulations, the European Union) launched a public consultation exercise. Most important of these reforms, point to solve the packaging and supply chain activities related problems. Proposed measures to require that all products with anti-theft Kai packaging (tamper-evidentpackaging), use of explicit and implicit validation, through a unified coding standard to a certain level to strengthen the product package labeling, prohibiting re-packaging of medicines, strengthen the responsibility and criminal penalties.
Addition to addressing the packaging and from producer to end-users of this problem in the supply chain outside, EC also pointed out that the API does not meet the specifications on this issue. EC in its proposal that the drug may be counterfeit or substandard raw materials for pharmaceutical products into the supply chain to which the safety of the patients had additional risk. For example, in early 2000, containing gentamicin
Antibiotic Appeared in a variety of side effects, it was considered inappropriate and production of these side effects occur and the active substance containing impurities.
Mandatory notification EC is considering a number of measures, the raw material production and GMP drug made more stringent inspection requirements. One of these measures is to drug the raw material manufacturers and importers to implement the mandatory notification procedure. EC proposal, the current EU legal framework API is only applicable to the production stage, distributors, traders, agents and broker activities are outside the EU laws and regulations.
EC proposed drug production and imports of raw materials to comply with the mandatory notification procedures, and information into the EU databases, such as by expanding the EudraGMP database functionality to do this. EudraGMP database to accommodate all the production information, as well as by the European Economic Area, the import license issued by the competent department of information, also contains information on GMP certificates.
Behalf of the European pharmaceutical companies, trade organizations, "European Federation of Pharmaceutical Industry Association" (EFPIA) agreed in principle to the recommendations of EC measures, but it also emphasized the importance of using risk management strategies.
EFPIA in a prepared statement that, for all the different supply chain participants, need to clarify their roles and responsibilities for the qualified person review the API, should they establish minimum qualifications and experience requirements.
EFPIA stressed that risk management is necessary, the cooperation of other agencies as well as their written examination report should seek to avoid duplication phenomenon.
EU member countries are also parties to the dispute from a trade-off. British drug manufacturer supervision of "Drugs and Health Products Authority" (MHRA) that the mandatory notification procedure should not only be included in a national production of bulk drugs, but also should be included in the flow of products between member countries. MHRA also pointed out the need to address typical problems of raw material drug production, or perhaps the end-user API is not known.
GMP review and strengthen the enforcement Order to improve the GMP review and enforcement, EC put forward further proposals. At present, the EU imports of raw material drug production and regulatory requirements are: holding pharmaceutical companies licensed to use the standard produced according to GMP API. EC public consultation in its report that, although the producers were asked for their raw materials used in drug testing, but this test work will not solve the residue or the inappropriate use of toxic solvents and impurities of the problem.
This end, EC made the following recommendations: first, to make medical products manufacturers and importers of the bulk drug suppliers in accordance with GMP standards by regular audits carried out as a mandatory practice, and asked staff have sufficient qualifications; Second, the case of scientific feasibility by discriminating analytical techniques (such as fingerprint technology) to exercise control on the API, and asked nearly infrared spectroscopy as identification of a mandatory approach by means of these tests to identify whether the production process there is a deviation, and the production base from which each batch of product; Third, the market in the European Community relating to the implementation of GMP standard API transformed into EC law in order to strengthen enforcement.
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