GMP News No. 513
10 February 2005
Recently published APIC Industry Best Practice documents
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.
Please click here for the detailed programme. If you have any further questions, please do not hesitate to contact us.