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GMP News No. 318
17 June 2003
Batch Release and Certification in the European Context
- The MRA between Europe and Switzerland -
You can find the "Explanatory Notes" published by EMEA at:
Since an MRA assumes in general equivalence of the respective GMP inspection systems of the two states involved, a batch of medicinal product can be imported/exported from one country into the other without the need for a second complete batch test by the consignee. However, this regulation, which is meant to avoid double work, requires the following conditions:
The last condition points to the special responsibility of the Q.P. In case parts of a single batch are delivered to different importing sites at different times, communication between the Q.P. of the "official importer" and the individual sites has to go off smoothly. This is an important task of the Q.P. as he trusts in the supplier's certificate and confirms with his signature the GMP-conform manufacture of each part of the batch. In principle, the Q.P. can do this without ever having seen the batch physically. However, this batch has to exist physically before it can be released.
The requirements on the content of a batch certificate have been published by EMEA in the form of an internationally harmonised document and can also be found at http://www.emea.eu.int/htms/technical/mra/mra.htm.
As, in the case of globally acting companies, several countries - also outside the economic sphere of the EU - are involved, this may give rise to complex situations. In a "Questions and Answers" document, EMEA tries to give answers to the most important questions regarding the EU-Swiss MRA. You will find this document at http://www.emea.eu.int/pdfs/technical/mra/ch/008402en.pdf. It also deals with contract manufacture and with the manufacture of investigational medicinal products.
According to the Explanatory Notes, Part II, the described procedure should also be followed for bulk products, intermediate products, partially packed products and active pharmaceutical ingredients as well as for investigational medicinal products.