Batch Release and Certification in the European Context - <br>The MRA between Europe and Switzerland

GMP News No. 318

GMP News
17 June 2003
 

Batch Release and Certification in the European Context

- The MRA between Europe and Switzerland -

 
On 1 June 2002, the MRA (Mutual Recognition Agreement) between the EU and Switzerland came into force. Chapter 15 of Annex 1 to this agreement regulates batch release and certification within the framework of import and export. Its content is interpreted in the "Explanatory Notes," a comment on chapter 15 of Annex 1 drawn up jointly by the EU Commission and the Swiss authorities. This document is divided into 4 parts:

  • Part I: Finished Products
  • Part II: Bulk and Intermediate Products
  • Part III: Specific Issues
  • Part IV: Official Batch Release for Vaccines and Blood Products

You can find the "Explanatory Notes" published by EMEA at:
http://www.emea.eu.int/htms/technical/mra/mra.htm

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 manufacturer/exporter and the consignee/importer each employ a qualified person (Q.P.); in Switzerland, this person is called "responsible person."
  • The Q.P. of the manufacturer/exporter has to certify the batch.
  • The Q.P. of the consignee/importer is given this batch certificate and administers it (entry in a batch register).
  • There must not be more than one "official importer" for an entire batch.

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.

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG
  

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