In March of 2006 the European Medicines Agency (EMEA), on behalf of the heads of medicines agencies issued a reflection paper (http://www.emea.eu.int/Inspections/docs/QPdiscretion.pdf) on the handling of minor deviations from the details described in the marketing authorisation for medicinal products.
Essentially the reflection paper described procedures for dealing with exceptional, un-planned and one-off deviations to the manufacturing process and/or analytical control methods for medicinal products. The paper still required that active substance(s) and finished product specifications be complied with. Any use of the process to deal with the observed deviations had to be under the responsibility of the Qualified Person.
The principles set out in the paper seemed to emphasise the important responsibilities of the Qualified Person and recognise the professional competence of QPs to assess the significance of deviations in quality terms.
At the time the European Commission indicated that it was ready to support the principles being implemented as an amendment to Annex 16 to the European Union's GMP guide depending on feedback on the practical aspects.
The EMEA has recently issued a follow up paper seeking the experience of industry on the application of the principles set out last year and asking a number of questions on the practicalities of using the procedures described (http://www.emea.eu.int/Inspections/docs/QPdiscretionfeedback.pdf).
The outcomes of this call for information and the sharing of experiences using it will be of great interest to all involved as will be the ensuing decision of The Commission as to whether or not to enshrine it in The EU GMP Guide.