In-depth Understanding
Since 2004 strict EU legislation has governed the import and release of Investigational Medicinal Products (IMP’s) for use in Europe to ensure that products comply with European cGMP. This legislation brought the import and release of IMP’s under the regulatory standard already in operation for registered (commercial) products.
Under Clinical Trial Directive 2001/20/EC products must first be imported into a licensed facility within the European Union and subsequently released by a Qualified Person (QP) who is named on a manufacturing authorisation and possesses the knowledge of current regulatory, quality control and manufacturing practice necessary to guarantee compliance.
For commercially available medicines the QP takes responsibility for the release of product to market in accordance with EU Directives 2003/94/EC (GMP) and 2001/83/EC (medicinal products for human use) and 2001/82/EC (medicinal products for veterinary use).
Brecon’s team of highly experienced QP’s can assist in smoothing the progress of a wide range of dosage forms products through the regulatory process worldwide – from clinical development to full commercialisation. Our QP’s are qualified to graduate level in pharmacy, chemistry or biology and up-to-date with current legislation affecting client’s operations and products.
Our QP’s take responsibility for all stages of the compliance process, including auditing manufacturing sites to confirm cGMP compliance and certifying products for use in clinical trials or, for registered products, release of the product to market.
We also offer clients a QP consultancy service to ensure their operations are in line with all relevant Directives and other regulations. This service also provides support in the preparation of regulatory documentation for submission of an MAA or IMPD/CTA.
Brecon can provide the above as a stand-alone service or in conjunction with our Analytical, Clinical Supply or Commercial Packaging Services.
Download our QP Services Brochure (PDF)
