EMEA Publishes "cGMP Notes"

GMP News No. 508

GMP News
1 February 2005

EMEA Publishes "cGMP Notes"

For many years now, the US-American FDA has been publishing cGMP Notes. These are compilations of current GMP questions with the correct answers given by the Agency. Within the framework of the cGMP Initiative for the 21st Century, the FDA has transformed the cGMP Notes into the "Questions and Answers on cGMP for Drugs". 
On EMEA's website, you can now find at least one Q-and-A session on GMP. It contains the following question and answer:

GMP Question:
Is it possible to use multiple Batch Numbers in Packaging of Medicinal Products?

GMP Inspectors recently discussed the desirability of more than one batch number appearing on the packaging of medicinal products.

It is normal practice for companies to use a bulk batch number that is different from the finished product batch when the bulk is packaged as several sub-batches. There is normally an element in the numbering format common to the bulk batch and finished product batches that clearly ties these together and the difference normally takes the form of a suffix, prefix or both.

A matter of concern for the inspectors is when the bulk and finished product batch numbers are completely different and there is no obvious connection between the two. Even though the manufacturer has a system of traceability, the inspectors agreed that this is an undesirable practice and should be avoided. The main reasons for this are:

  • Patients and healthcare professionals may mistakenly believe that there has been a packaging error, 
  • Hospitals often remove products from the outer packaging and traceability may therefore be lost, 
  • Confusion may occur in the case of recall rendering such action potentially ineffective. 

It is accepted that there may be exceptional cases where multiple batch numbers are displayed on a pack such as in combination product packages. In addition products that require relabelling following parallel distribution are expected to display the original manufacturer's batch number. Manufacturers are recommended to discuss individual cases with the relevant Supervisory Authority. In all cases traceability must be maintained.

Source: EMEA Website http://www.emea.eu.int/Inspections/WhatsNew.html

Our tip: 
Do you have similar questions concerning GMP compliance, especially on release?

ECA is organising the event "The Qualified Person" in Prague, Czech Republic, on 12 and 13 May. 8 Experts from globally operating pharmaceutical companies as well as the former Head of GMP Inspections of MHRA in London are among the speakers!

If you are working in the field of packaging, we recommend you the GMP Education Course Quality Testing of Pharmaceutical Packaging Materials, to be held in Berlin, Germany, on 20 and 21 April.


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