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Changes concerning active ingredients
News from the USA: BACPAC I now approved
The Guidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing, and Controls
Documentation, published in draft form in November 1998, has now been approved in its final version by the Food and Drug Administration (FDA) and has been in effect since February of this year.
BACPAC I gives recommendations for dealing with changes of manufacturing site, batch size, equipment, specifications and manufacturing processes in the manufacture of synthetic active ingredients and for the synthetic manufacturing steps for active ingredients obtained by semi-synthetic means.
Any change in the manufacturing method of active ingredients harbors the risk that the quality of the final product may be changed, e.g. the physical properties of the active ingredients (e.g. polymorphy) or the contamination profile. The risk here that the quality of the final product will be influenced is greater the later in the manufacturing process that this change is made. The core of the BACPAC guide is the following decision tree, which defines the area of application of BACPAC.
(from: Guidance for Industry, BAPAC I:
Intermediates in Drug Substance Synthesis, Attachment A: BACPAC I Decision
Tree; February 2001)
BACPAC refers in its turn to the following additional guides:
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Changes to an Approved NDA
or ANDA, CDER, November 1999.
-
Changes to an Approved
Application for Specified Biotechnology and Specified Synthetic
Biological Products, Center for
Biologics Evaluation and Research (CBER) and CDER, July 1997.
-
Draft - Chemistry,
Manufacturing and Controls Changes to an Approved NADA or ANADA,
CVM, June 1999 (notice of availability published in the Federal
Register on October 1, 1999 (64 FR 53281)).
-
Submitting Supporting
Documentation in Drug Applications for the Manufacture of Drug
Substances, CDER, February
1987.
BACPAC I applies to
- NDAs (new drug
applications)
- ANDAs (abbreviated new drug
applications)
- NADAs (new animal drug
applications)
- ANADAs (abbreviated new
animal drug applications)
- DMFs (drug master files)
- VMFs (veterinary master
files).
and can be downloaded from the following address:
http://www.fda.gov/cder/guidance/3629fnl.pdf
In view of other changes concerning active pharmaceutical ingredients
we would like to draw your attention to this year's 4th
APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
which is to take place in Vienna from September 26 - 28, 2001. This year's
conference will include a GMP and a regulatory affairs segment.
From FDA Dr. Yuan-yuan Chiu has already agreed to speak on the topic of
"New developments of post-approval changes". In addition to
BACPAC, of course the GMP Guide ICH Q7 and TSE and falsification of
active ingredients will be an important topic.
In this year too the European Chemical Industry Council (CEFIC/APIC)
will be organizing this event and has invited both European and North
American opinion-makers to Vienna. This year service providers will have
the opportunity for the first time to take part to a limited extent in an
integrated exhibition.
Click
here to find out more.
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