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GMP News No. 513
10 February 2005
Recently published APICIndustry 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 ofrepresentatives from various companies within the Active PharmaceuticalIngredients 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, "(…) detailedguidance for the qualification of new equipment is given in existingguidelines (…). However APIC recognized there is only limitedguidance with respect to the qualification of existing equipment.Therefore APIC has prepared a document to reflect current thinking of theAPI manufacturing industry on this matter (…)". The document is"(…) intended for use by manufacturers of Active PharmaceuticalIngredients (APIs) and API intermediates that use existing facilities,system, equipment and utilities. (…)".
APIC's Technical Change Control document is a guideline for theestablishment of a control procedure for technical equipment, includingrelated utilities, computerized systems, and facilities used in themanufacture of APIs.
The guideline refers to § 13.10 ICH Q7A requiring that 'a formalchange control system should be established to evaluate all changes thatmay affect the production and control of the intermediate or API'. TheAPIC document "(…) covers only the part concerning technicalequipment and related utilities, computerised systems and facilities. Aformal change control system should be established to evaluate all changesthat may affect production and control of the intermediate or API. Thereshould be an written procedure in place to evaluate the impact (e.g.,regulatory impact) of proposed changes on other possibly affected systemsand 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 18-22April 2005 in Basel /Switerland.
During the 'Masterclass Week' a total of 16 out of 18 chapters of ICHQ7A will be covered in detail. You find a reference made to the relevantchapters of ICH Q7A mentioned in the graph below (look for'Ch for the referred ICH Q7A chapter).
As these courses are sponsored by APIC/CEFIC they are being held byspecialists from APIC member companies acquainted with the daily hurdlesof compliance.