Qualified Person (QP) Release and Consultancy Services
Each batch of finished product, whether a commercial product or an investigational medicinal product (IMP) must be certified by a Qualified Person (QP) named on a manufacturing licence within the European community (EC) or European economic area (EEA) before being released for sale or supply in the EC/EEA or for export.
Our Qualified Person Consultamcy provides QP's who are typically licensed pharmacists, biologists or chemists (or a person with another permitted academic qualification) who has several years experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight and QP release services has been extended to material for use in clinical trials since the introduction of the Clinical Trials Directive 2001/20/EC in May 2004 when the directive was implemented within the UK for enforcement by the Medicines and Healthcare Regulatory Agency (MHRA).
The purpose of controlling batch release is to ensure that each batch has been manufactured in accordance with the requirements of its marketing authorisation (for commercial products) or clinical trial authorisation (for IMPs), the principles and guidelines of EC Good Manufacturing Practice (GMP) or the GMP of a third country recognised as equivalent under a mutual recognition agreement (MRA) and any other relevant legal requirement before the product is placed on the market or distributed for use in a clinical trial.
As part of our QP release consultancy, Biotec has a team of QPs available who are highly experienced in both marketed products and IMPs. We have vast experience of working with clients, particularly from North America, Israel, SE Asia and within the EC/EEA, helping to facilitate the smooth importation of IMPs into Europe for use in clinical trials both within the EC/EEA and other regions.
Our QPs will conduct audits of manufacturing facilities ensuring that each batch has been manufactured in accordance with cGMP guidelines.
We will arrange the collection of your drug from its manufacturer and import the supplies into our licensed facility in the European Union (EU). Our QPs will certify your IMP for use in clinical trials in Europe in accordance with the Clinical Trials Directive 2001/20/EC. Where Biotec provide further assembly operations our QPs will certify the finished product prior to release. If the product is a comparator our QPs will ensure that all necessary controls are complied with prior to certifying the product. For commercially available, marketed products, our QPs will certify the product in accordance with the relevant marketing authorisation ensuring that the principles of GMP are adhered to as outlined in GMP Directive 2003/94/EC and medicinal products for human use directive 2001/83/EC.
QP Consultancy service
In addition we can provide a QP Consultancy service offering specialist advice by telephone, e-mail or face-to-face, to guide you through current legislation and ensure that your pharmaceutical operations are in compliance with relevant EU Directives and GMP guidelines.
Our Qualified Person Release Services Key Facts:
- Team of seven expert QPs on our manufacturing licence(s) with varying dosage form experience in>cluding steriles and biological/biopharmaceuticals experience.
- Advice on manufacturing site selection.
- Audits of global manufacturing sites, including primary and secondary manufacturing operations.
- Import supplies into Europe.
- Batch record review.
- QP Consultancy Service.
- IMPs and Marketed products.
Should you require any further information regarding our Qualified Person (QP) Services or our QP Consultancy please contact us
Latest news at Biotec
Registered in Wales No. 3483808
Registered Office: Biotec Services International Limited, Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend CF31 3RT UK
© Copyright 2009 Biotec