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On the WHO homepage you can now find a topical document titled Guide to Good Storage Practices for Pharmaceuticals,
which has been elaborated in close co-operation with the International Pharmaceutical Federation (FIP)
and which will thus probably replace the quite old FIP Guideline on Good
Storage Practices of 1980.
The new WHO document on GMP-compliant
storage represents a complement to existing GMP regulations issued by WHO.
These new Good Storage Practices are valid not only for manufacturers of
medicinal products, but also for pharmaceutical importers, contractors and
wholesalers.
The focus topics are:
- Personnel
- Premises and facilities
- Storage requirements
- Returned goods
- Dispatch and transport
- Product recall
Compared to the former FIP Guideline,
several new requirements have been added, some old ones, specified. Here some
examples:
- Precautions must be taken to prevent
unauthorised persons from entering storage areas.
- Materials and pharmaceutical products
must not be stored directly on the floor.
- There should be written programmes for
many work routines (sanitation, pest control, measures in case of
spillage, cleaning procedures for the sampling area, handling of
returned goods, etc.).
- Computerised systems used for storage
administration (incl. quarantine and storage of rejected materials)
have to be validated.
- The traditional term "First in
– First out" (FIFO) is now replaced correctly by the more
specific "first expired/first out" (FEFO) principle.
- In addition to the usual GMP
requirements on the monitoring of storage conditions (temperature
recording with calibrated equipment), temperature mapping should prove
the uniformity of the temperature.
- Returned goods may only be returned to
saleable stock after the quality has been re-evaluated.
In case patients have returned pharmaceuticals, these must not under
any circumstances be returned to the saleable stock.
- As for transport, especially the use
of dry ice in cold chains is discussed (danger of damaging materials
by freezing them accidentally) and the monitoring of transport
conditions with the help of appropriate recording devices is recommended.
An appendix to the new WHO Guideline
lists standardised storage and labelling conditions for drug products,
which had already been fixed by WHO in this form in 1996.
Unfortunately, this list does not contain
any reference to the Controlled Room Temperature mentioned in the
USP under "Stability" in the General Chapter <1151>. The controlled
room temperature takes the mean kinetic temperature into account and
allows thus for a certain flexibility regarding deviations from the
prescribed storage temperature.
By the way, this concept of mean kinetic
temperature has also been mentioned in the European CPMP Note for Guidance
on Declaration of Storage Conditions for Medicinal Products in the Product
Particulars and Active Substances (CPMP/QWP/609/96/Rev.1).
Therefore, it would also have been
desirable to read this term in WHO's new Good Storage Practices.
But the new Guide just says that temperature deviations may be tolerated
only during short-term interruptions, e.g. during local transportation.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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19-20 June 2013 