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New FDA Guidance for Industry Container
Closure Systems for Packaging Human Drugs and Biologics – Questions and
Answers
In May 2002, FDA
(CDER and CBER) published a Guidance for Industry giving answers to
questions asked by applicants in relation to the 'Guidance on
Container Closure Systems for Packaging Human Drugs and Biologics' issued
in May 1999.
Two of the three questions refer to the
storage and shipping of 'bulk drug products'. A footnote explains
that bulk drug product means 'finished dosage form that has not yet been packaged into the container
closure systems intended for market and/or sale.'
Information on container closure systems
used for bulk drug products only needs to be included in the application
for biologics (e.g. proteins). For all other products, no such information
has to be provided in the application. However, FDA does require that the
suitability of the containers for the intended purpose can be proven by
means of adequate data. These data also should be made available during
FDA inspections on demand.
As reason why more data have to be
included in the application concerning biologics FDA cites the fact that
the probability of adverse effects on the product quality during storage
or shipping is much higher with biologics and proteins than with other
products.
Note: In FDA's Human Drug cGMP Notes of
December 1995, Paul Motise wrote about the storage of bulk drug products
that physically/chemically stable bulk drug products can be stored up to
30 days under suitable storage conditions without having to provide
stability data. For unstable bulk drug products or for materials that are
planned to be stored for more than 30 days, stability data have to be
provided according to a stability testing plan approved in advance.
The above-mentioned FDA Guidance on packaging
materials of May 1999 also included the item 'Containers for Bulk Drug
Products': the storage containers should provide adequate
protection and be manufactured from materials that are compatible and safe
for the intended use. In case a firm intends to hold bulk drug products in
storage, the maximum storage time has to be described and justified. If
the storage is meant to be extended, stability data have to be provided.
However, Paul Motise's concrete indication from which storage time on
stability data have to be provided (30 days) is not included in the
Guideline.
As to shipping containers for bulk
drug products (e.g. for the transportation to the contract packager), FDA
considers the suitability to be proven when annual batches of the packaged
product are included in post-approval stability studies. It goes without
saying that the shipping containers, too, have to protect the product
sufficiently and be manufactured from appropriate materials.
In the next months, we offer you the
following events on the topics of stability and packaging:
ECA Education Course
Quality
Control and Quality Assurance of Pharmaceutical Packaging Materials
22-23 October 2002, Barcelona, Spain
Stability
Testing in the Pharmaceutical Industry
28-29 November 2002, Barcelona, Spain
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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