In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to Batch Release a drug product (Batch Disposition) the QP is required to be on a licence known as an MIA (Manufacturer’s/ Importation Authorisation).
When a company contract MIAS be it for a clinical trial or commercial release, our first step is to put their drug product on the MIAS MIA licences. In 90% of cases our clients then opt to go the Contract MIAS QP route (Pay As You Go model) rather that recruiting their own personnel for Batch Release. However, if a client does have their own QP the option is available to add them to the relevant MIAS MIA for Batch Disposition to occur.
Should a client go the Contract QP Route the MIAS QP will first require training on the client’s product, processes and Pharmaceutical Quality System, including the interactions with third party Quality Systems. This is often carried out on-site or as appropriate and will include preparation for batch release activities.
QP Familiarisation may include:
- Manufacturing process and controls
- DS and excipient control
- Qualification/validation (process and cleaning)
- Packaging process
- Preventative maintenance and calibration controls
- MA review
- QC methods and product specifications
- Method validation/verification
- Stability review
- Quality Systems in place
- Previous PQRs
- Supply chain qualification
The legislation behind this is as follows:
“EU Directive 2001/20/EC states that the QP is responsible for ensuring that each batch of medicinal products has been manufactured and checked in compliance with the requirements of EU law, the principles and guidelines of GMP for medicinal products for human use and that in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC (and) in accordance with the product specification file.”