Wasdell QP Services

Wasdell Group work to the highest standards of GMP and GDP with rigorous quality controls, and employ quality professionals across our sites.


What sets us apart?

Exceptional Quality Standards

We work to the highest standards of GMP and GDP with rigorous quality controls, and employ quality professionals across our sites. Within the Group we have access to permanently employed or contract Qualified Persons to fit with client needs. There are further plans to expand the team with additional QPs and trainees.

Service Focus

We pride ourselves on delivering high quality, reliable, flexible and responsive services to our customers with unrivalled lead times.

Flexible Solutions

We provide solutions to a range of outsourcing requirements from designing packaging through to manufacturing, packaging and distributing products for the healthcare industry.

Overview of QP Services

  • Our QP Services include all routine QP activities covering both our internal and external customers by providing optimum contact and support for their medicinal products.
  • The aim of the service will ensure the business operates compliantly, diligently and responsively to meet all our customer needs when working in complex and sometimes virtual supply chains.
  • As part of the service, the team can provide operational quality advice and audit services to support new product introduction, active pharmaceutical ingredient (drug substance) audits with declarations.
  • Importation activities will be supported together with certification for market release depending on client support (as needed) to deliver a full service.
  • Drug product and contracted out activities such as testing laboratories can be supported as part of the supply chain assessment.
  • Utilising our internal resources, advice on project validation can be supported as required.

Annex 16

On 12 October 2015, Annex 16 Certification by a Qualified Person and Batch Release was published by the European Commission in direct response to globalisation of the pharmaceutical supply chain and the advances in technology, such as Process Analytical Technology (PAT) and Real Time Release Testing (RTRT).

The updated Annex 16 is now aligned with the concepts of the ICH trilogy, (Q8, Q9 and Q10) and provides clarity on the batch release process and distinguishes between the three steps:
(1) Checking of the manufacture and testing of the batch.
(2) Certification of the batch by the Qualified Person.
(3) Assigning a “released” status to the finished production regards to sale/supply/export by the QP.

QP Regulations

Legal Basis for Qualified Persons in Europe.

The Legal Basis for the Qualified Person is defined in the DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TO MEDICINAL PRODUCTS FOR HUMAN USE.

For Veterinary Products, the requirements are defined in DIRECTIVE 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products.

In Article 48, the Directive 2001/83 (for veterinary medicinal products, please read Article 52 of Directive 2001/82) requests that EU Member States have to assure that each holder of a manufacturing authorisation has to have at least one QP.

Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorisation has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51.

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