In the end of 2004, the APIC (Active Pharmaceutical Ingredients Committee)
added two further guidelines to their Industry Best Practice Documents.
These documents were prepared by Task Forces consisting of
representatives from various companies within the Active Pharmaceutical
Ingredients industry that participate in the API Committee of CEFIC
(European Chemical Industry Council).
Both documents can be downloaded from APIC's webpage (www.//apic.cefic.org):
As mentioned in the Qualification document, "(…) detailed
guidance for the qualification of new equipment is given in existing
guidelines (…). However APIC recognized there is only limited
guidance with respect to the qualification of existing equipment.
Therefore APIC has prepared a document to reflect current thinking of the
API manufacturing industry on this matter (…)". The document is
"(…) intended for use by manufacturers of Active Pharmaceutical
Ingredients (APIs) and API intermediates that use existing facilities,
system, equipment and utilities. (…)".
APIC's Technical Change Control document is a guideline for the
establishment of a control procedure for technical equipment, including
related utilities, computerized systems, and facilities used in the
manufacture of APIs.
The guideline refers to § 13.10 ICH Q7A requiring that 'a formal
change control system should be established to evaluate all changes that
may affect the production and control of the intermediate or API'. The
APIC document "(…) covers only the part concerning technical
equipment and related utilities, computerised systems and facilities. A
formal change control system should be established to evaluate all changes
that may affect production and control of the intermediate or API. There
should be an written procedure in place to evaluate the impact (e.g.,
regulatory impact) of proposed changes on other possibly affected systems
and to approve them (…).
Please allow us to refer to an important API event in the near future,
sponsored by APIC/CEFIC: The API Masterclass Courses from 18-22
April 2005 in Basel /Switerland.
During the 'Masterclass Week' a total of 16 out of 18 chapters of ICH
Q7A will be covered in detail. You find a reference made to the relevant
chapters of ICH Q7A mentioned in the graph below (look for
'Ch<number> for the referred ICH Q7A chapter).
As these courses are sponsored by APIC/CEFIC they are being held by
specialists from APIC member companies acquainted with the daily hurdles
of compliance.
Special offers:
- You can choose one or more courses out of 12 different courses that
cover nearly all chapters of ICH Q7A.
- You have the opportunity to achieve a Masterclass Certification by
participating in 4 out of 12 courses.
Please click here for the detailed programme. If
you have any further questions, please do not hesitate to contact us.
