Article by Sue Mann, founder and Managing Director, Sue Mann Consultancy Ltd
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect. Here are the top ten things that sponsor companies should know about the QP Process.
1. DO know that the role is embedded in the whole process and is not “just” a release function at the end. The QP needs to be satisfied regarding all aspects of the batch in question – what went into it and how/where it was made/tested/packed. Sponsor companies should prepare for questions regarding this. Some standard documents that a QP will ask for are –were any stages of manufacture outsourced and if so, do you have an audit report/Technical Agreement which demonstrates that this site manufactures in accordance with EU GMP requirements.
2. DO know that this also includes the API or DS that is relevant for the batch in question. The QP needs to be assured this has been made to a satisfactory standard. This may involve an on-site audit, or request for a significant amount of information about the site and the API that has been manufactured.
3. DO know that the QP process differs from what happens in the US. All sites in the EU relating to manufacture/packing and storage of Clinical Trial products need to be authorized/have a relevant licence to allow the particular activity. This is not the case in the US.
4. DO control and monitor shipment of products that are stored at ambient temperature. In the EU it is expected that the temperature of all products, regardless of required temperature conditions, is controlled and monitored. All movements of the product must be accompanied by temperature loggers which (hopefully!) demonstrate that the product was stored within the correct temperature range. We are all used to this requirement for refrigerated and frozen products, but sponsor companies may be unaware of this requirement for products that can be stored at ambient temperature.
5. DO know all your sites that have to be certified. The QP certification is also required for products that may/will be used in a country outside the EU. So, if a site in the US and a site in the EU pack the same CT materials for an investigator site in South America – the product shipped from the EU to this site will need to have been QP certified.
6. DO understand your trial’s back up or escape medications, etc. If a trial requires any back up or escape medications etc., know that the requirements for these – where they are sourced, where and how they can be moved around and the site licenses required for these activities are complicated and vary throughout the EU. It is strongly recommended you check local requirements for each country you wish to do work in.
7. DO know that there may be more than 1 QP involved in the whole process for obtaining CT supplies. This could easily be the case if the bulk product is manufactured in one EU country (called Member State) and then packed in another EU country.
8. DO know that in the EU, it is common practice to add the “use by” or “retest date” on the label on the CT packs. At present, where used, this would typically be on the secondary package (e.g. wallet, carton) but please note that when the CT Regulation comes into effect, this states the requirement also applies to the primary pack – e.g. vial, bottle.
9. DO know that recent changes in the EU GMPs, which focus on the prevention of cross contamination when working in multi- product facilities,
lso apply to those facilities where CT products are manufactured and packed. This may result in more focused questions from a QP regarding risks of cross contamination in a multi-product facility and what measures a company has taken to reduce these –e.g. dedicated product contact parts, cleaning studies using the new toxicology based guidance for setting acceptance limits. .
10. DO know that after QP certification, the QP should still be involved (or at minimum informed), if any updates to the labelling are required (e.g. shelf life extensions), any materials need to be moved to another site and of course any quality issues that may arise. The QP role does not end at certification but is involved throughout the use of the investigational product until the trial concludes.
About Sue Mann Consultancy Ltd (SMC)
Sue Mann is the founder and Managing Director of Sue Mann Consultancy Ltd. Sue is a very experienced, energetic, highly effective QA professional working in the Pharmaceutical Industry, who over the years has achieved many significant improvements in both quality and compliance through the introduction of sound, pragmatic practices.
SMC Ltd provides advice and support in all areas of Pharmaceutical Quality and GMP, to help organisations operate effective and compliant Quality Management Systems.