The GMP principles for the manufacture, packaging and storage of active
pharmaceutical ingredients and medicinal products are in many ways defined
and interpreted by means of regulations, guidances and recommendations.
For the GMP-compliant shipping of medicinal products, however, there are
only few meaningful documents. Nevertheless, the pharmaceutical industry
has been acting on a global scale for some time now. Therefore, the topic
of GMP for the distribution practice plays an important role.
At the moment, there are 3 initiatives
aiming at the creation of regulations for Good Distribution Practice and
at the definition of corresponding standards. One of these initiatives was
triggered by the PDA (Parenteral Drug Association). In the middle of 2002,
PDA brought the 'Pharmaceutical Cold Chain Discussion Group'
(PCCDG) into being. This body is working on a guideline on GMP-compliant
distribution practice for temperature-sensitive finished drug products,
intermediates and APIs in close co-operation with its European equivalent,
the 'Cold Chain Committee' (C3). This guideline describes specifications
for primary and secondary packaging materials as well as the principles of
shipping validation.
Another important initiative was started by USP. In the pharmacopoeial
forum (issue Sept/Oct 2003), the draft of the informational chapter '<1079> Good Storage and Shipping
Practices' was published for commenting for a period of 6 months.
This document is directed at manufacturers of medicinal products, repackagers,
distributors, shippers, and pharmacists, and deals with the
following topics:
Storage area:
- Establishing of temperature profiles
- Storage at controlled RT - cool, cold, freeze storage
- Regulations for the entry of goods
Distribution and shipping of medicinal products:
- Cold chain management
- Transport vehicles –
vehicle validation
- Choice of packaging / channel of distribution
- Implementation of standardised stress tests
- Protection of fragile freight
At the beginning of this year, the WHO published a document titled 'Good
Distribution Practices (GDP) for Pharmaceutical Products' for commenting
until the end of March. This guidance contains regulations on the
following points:
- Quality management, organisation and personnel
- Premises and storage areas
- Transport vehicles, external packaging and labelling
- Distribution and shipping practice, documentation
- Repackaging and relabelling
- Complaints, recalls and returned products
- Imports and contracting
According to the schedule, this guidance is meant to be published for
commenting a second time in June this year, and presented to the '39th
WHO Expert Committee on Specifications for Pharmaceutical Preparations'
in autumn.
This guidance is the counterpart of the document 'Good Trade and
Distribution Practices for Pharmaceutical Starting Materials,' which was
published in the WHO Technical Report Series in 2003. You can download
it by clicking here.
By the way, at the European level, the EU 'Guidelines
on Good Distribution Practice of Medicinal Products for Human Use' (94/C
63/03) dating back to 1992 form the official basis for inspections.
(Click here
to view the document.)
The initiatives presented above show that there is need for
regulation in order to achieve GMP-compliant processes in distribution
and shipping and that, on this topic, there will be relevant
regulations to be observed in the future.
Author:
Dr G. Becker
CONCEPT HEIDELBERG
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