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Excipients & Actives for Pharma
No. 26, 2011
REGULATORY NEWS
CEP procedure and the availability of CEP for BASF products
Dominik Odenbach
In order to guarantee consistent product
quality, pharmaceutical manufacturers must be
able to demonstrate standardized, reliable quality
of pharmaceutical ingredients in line with existing
pharmaceutical monographs. To ensure
quality, the Certification Secretariat of the European
Directorate for the Quality of Medicines
(EDQM) grants Certificates of Suitability of
Monographs of the European Pharmacopoeia
(CEP) to manufacturers who can show that their
production is compliant with the existing
pharmaceutical monograph of the European
Pharmacopoeia. To apply for this certificate,
pharma ceutical ingredients manufacturers must
present a comprehensive dossier, including information
on chemistry, manufacturer, process,
characterization, controls, reference standards,
container closure systems, stability.
The CEP procedure was created in 1994. CEPs
are accepted in all 36 member states of the
European Pharmacopoeia Convention. According
to the EDQM, non-European countries also
accept CEP (e.g. Argentina, Brazil, Malaysia,
Mexico, New Zealand, Russian Federation,
Singa pore, South Africa, Taiwan, and others).
The CEP procedure has many advantages:
• Efficiency through centralization
Only the EDQM reviews the applications and
grants CEPs. A DMF must be reviewed by
indi vidual health authorities, but the CEP
procedure is a single centralized evaluation.
There is no duplication of work. Potential
diver gences in assessment are avoided.
• Less documentation
Once granted, the CEP is only a few pages
long whereas a DMF is a dossier with a large
volume of documentation, which must be
reviewed with each new registration.
• Speed
The information provided in the dossier is
approved by the EDQM only once, with the
granting of a CEP. After this, each CEPbased
registration is processed quickly.
• IP protection
The CEP dossier is only reviewed by one
pub lic regulatory body (EDQM).
Customer benefits
For the pharmaceutical manufacturer, the CEP
makes it easier to assess suppliers and their
materials, without the need for conducting timeconsuming
and costly audits. Marketing authorizations
are easier to manage because CEP
replaces the majority of the application.
For the pharmaceutical
manufacturer, the CEP
makes it easier to assess
suppliers and their materials,
without the need for
conducting time-consuming
and costly audits.
BASF is seeking to achieve CEP for its active
ingredients and selected excipients. This will
allow the company to supply customers with
products compliant with the quality standards
of the European Pharmacopoeia. Plus, customers
will benefit from a straightforward service
solution.
All of the following products have valid status
and are classified under type chemistry (table 1):
Time and cost
The CEP procedure saves time (fixed time
frames; a single regulatory body) and cuts costs
for the industry and the licensing authorities. A
CEP costs a one-off fee of approx. 3,000 euros,
whereas a DMF will have to be provided to different
health authorities, leading to multiple fees.
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