13/14 April 2021
GMP News No. 515
15 February 2005
NewAPIC Guidance on the
At the end of 2004, APIC (Active Pharmaceutical Ingredient Committee), asector group of the EuropeanChemical Industry Council (CEFIC), published a "Guidance on Qualification of Existing Equipment". APICrepresents the interests of the industrial companies manufacturing APIs.
This guidance is 13 pages long and has 7chapters. The first four chapters consist in an acknowledgement,introduction and scope, as well as a presentation of the regulatoryrequirements. Chapter 5, the longest part, is the guidance itself. Thedocument is rounded off by references, a glossary and a list ofabbreviations.
The target group of this guidance is thecomplete API industry including manufacturers of API intermediates, APIstarting materials and perhaps even earlier stages.
The (main) chapter "Guidance" begins with the topic of riskassessment. The authors consider risk assessment to be a very helpfultool, 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, anddecision trees. However, it says that the list is not complete and mightbe continued by adding further techniques.
For the risk assessment of unit operations or functions, the documentlists 6 questions that help to assess the criticality with regard toa loss of quality and/or the occurrence of cross contamination.
If one of these 6 questions is answered in the affirmative, the respective functionis GMP-relevant. Afterwards, the probability of occurrence and thedetectability of a mistake should be considered and measures to reduce therisk, identified.
The text also gives an example for a technical GMP risk assessment.
A programme with 10 steps guides through the actual qualificationactivities:
A flow chart helps to clarify the 10-steps programme once more.
Our opinion: We think that this document is very practice-oriented. Thenumerous examples help to make the subject of qualification of existingequipment transparent and understandable. A surprising fact is that riskassessment itself is not mentioned before point 5 of the 10-stepsprogramme. However, in the corresponding flow chart, quite sensibly riskassessment comes second, directly after the Validation Master Plan. Sothis is just a minor inconsistency, which does not diminish the quality ofthe document.