EMEA Publishes "cGMP Notes"

GMP News No. 508

GMP News
1 February 2005

EMEA Publishes "cGMPNotes"

For many years now, the US-American FDA has been publishing cGMP Notes.These are compilations of current GMP questions with the correct answersgiven by the Agency. Within the framework of the cGMP Initiative for the21st Century, the FDA has transformed the cGMP Notes into the "Questions andAnswers 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 multipleBatch Numbers in Packaging of Medicinal Products?

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

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

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

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

It is accepted that there may beexceptional cases where multiple batch numbers are displayed on a packsuch as in combination product packages. In addition products that requirerelabelling following parallel distribution are expected to display theoriginal manufacturer's batch number. Manufacturers are recommended todiscuss individual cases with the relevant Supervisory Authority. In allcases traceability must be maintained.

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



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