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?
Answer:
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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