On 29 June 2009 the EMEA issued amongst others the following four Annexes for the harmonisation of monographs:
ICH Q4B Annex 5 - Disintegration Test
ICH Q4B Annex 8 - Sterility Test
ICH Q4B Annex 9 - Tablet Friability
ICH Q4B Annex 10 - Polyacrylamide Gel Electrophoresis
These four Annexes are the result of the corresponding Q4B processes. The documents were worked out and supplied by the Pharmacopoeial Discussion Group (PDG). Although the texts are considered as exchangeable, every single document still contains added restrictive phrasing from the view of the respectively involved regions (FDA / EU / MHLW Considerations).
ICH Topic Q4B Annex 5 Disintegration Test General Chapter (Step 4)
The interchangeability is not given
- if the tablets or capsules are longer than 18 mm and different equipment is used
- for delayed release, gastro-resistant or enteric-coated dosage forms
You can find this document at http://www.emea.europa.eu/pdfs/human/ich/30889508en.pdf
ICH Q4B Topic Q4B Annex 8 Sterility Test General Chapter (Step 4)
Here it is explicitly emphasised that "diluting and rinsing fluids should not have antibacterial or antifungal properties if they are to be considered suitable for dissolving, diluting, or rinsing an article under test for sterility."
Also, "when testing liquid parenteral preparations with a nominal volume of 100 milliliters in batches of more than 500 containers, the test is considered interchangeable if the minimum number of containers selected is either 20 or is 2 percent of the total number of containers, whichever is lower."
The complete document can be found at http://www.emea.europa.eu/pdfs/human/ich/64559208enfin.pdf
ICH Topic Q4B Annex 9 Tablet Friability General Chapter (Step 3)
This document comprises an interesting point for evaluation: "For interchangeability, the loss of mass for a single determination should be not more than 1.0 percent, unless otherwise specified in the dossier. When three determinations are conducted, then the mean loss of mass for the three determinations should be not more than 1.0 percent, unless otherwise specified in the dossier."
Please go here to find this document: http://www.emea.europa.eu/pdfs/human/ich/37980109endraft.pdf
ICH Topic Q4B Annex 10 Polyacrylamide Gel Electrophoresis General Chapter (Step 3)
With the exception of the above mentioned considerations mentioned in all these documents this Annex does not comprise any further indications concerning the analytical procedure or the acceptance criteria.
This document is available at http://www.emea.europa.eu/pdfs/human/ich/38113309endraft.pdf
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)