EU Qualified Person (QP).

EU QP Batch Release

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 certify a batch of a drug product the QP is required to be named 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 name their drug product on the relevant MIAS MIA. In 90% of cases our clients opt to use MIAS QPs (so-called Contract MIAS QP route (Pay As You Go model) rather than recruiting their own personnel for Batch Certification. However, if a client does have their own QP the option is available to name them on the relevant MIAS MIA.

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 SERVICE SUPPORTS

Supporting QP Services & Quality of your products in the marketplace.

SUPPORT & QUALITY

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

Should a client go the route of naming their own QPs on a MIAS MIA, these QPs will require training on the MIAS Pharma PQS. MIAS will also apply a quality oversight of the arrangement to safeguard the quality standards governing batch disposition.

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.”

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