GMP News No. 515
15 February 2005
APIC Guidance on the
At the end of 2004, APIC (Active Pharmaceutical Ingredient Committee), a sector group of the European Chemical Industry Council (CEFIC), published a "Guidance on Qualification of Existing Equipment". APIC represents the interests of the industrial companies manufacturing APIs.
This guidance is 13 pages long and has 7 chapters. The first four chapters consist in an acknowledgement, introduction and scope, as well as a presentation of the regulatory requirements. Chapter 5, the longest part, is the guidance itself. The document is rounded off by references, a glossary and a list of abbreviations.
The target group of this guidance is the complete API industry including manufacturers of API intermediates, API starting materials and perhaps even earlier stages.
The (main) chapter "Guidance" begins with the topic of risk assessment. The authors consider risk assessment to be a very helpful tool, which can be applied to all kinds of qualification (existing plants, equipment, systems).
The methods for assessing risks indicated in the text are HAZOP, FMEA, and decision trees. However, it says that the list is not complete and might be continued by adding further techniques.
For the risk assessment of unit operations or functions, the document lists 6 questions that help to assess the criticality with regard to a loss of quality and/or the occurrence of cross contamination.
If one of these 6 questions is answered in the affirmative, the respective function is GMP-relevant. Afterwards, the probability of occurrence and the detectability of a mistake should be considered and measures to reduce the risk, identified.
The text also gives an example for a technical GMP risk assessment.
A programme with 10 steps guides through the actual qualification activities:
A flow chart helps to clarify the 10-steps programme once more.
Our opinion: We think that this document is very practice-oriented. The numerous examples help to make the subject of qualification of existing equipment transparent and understandable. A surprising fact is that risk assessment itself is not mentioned before point 5 of the 10-steps programme. However, in the corresponding flow chart, quite sensibly risk assessment comes second, directly after the Validation Master Plan. So this is just a minor inconsistency, which does not diminish the quality of the document.