QP Services

We work to the highest standards of GMP and GDP with rigorous quality controls and employ experienced quality professionals
across all of our sites.


Our QP service ensures we operate compliantly, diligently and responsively to meet all our customer needs when working in complex supply chains.

We deliver all routine activities covering both our internal and external customers by providing optimum contact and support for their medicinal products.

Our growing team can provide operational quality advice and audit services to support new product introduction and API (drug substance) audits with declarations.

Our QP support offering includes:

  • Routine QP activities covering both internal and external customers.
  • Importation activities supported with certification for market release depending on client requirements
  • Quality advice and audit services
  • Drug product and contracted out activities such as testing laboratories can be supported as part of the supply chain assessment
  • Using our internal resources, advice on project validation can be supported as required

A partner you can rely

Production takes places 24/7, underpinned by an expert staff team. With over 40 years’ as a chosen outsourcing partner, our commitment to quality is embedded in our culture. Reliability of product supply is vital, as a group we operate a robust On Time In Full (OTIF) production planning system, and we take great pride an excellent reputation and proven track record on commitment to delivery.

Access to global markets

Wasdell offers its customers access to multiple markets and can facilitate global companies entering complex regulatory regions like Europe. From manufacturing to packaging and quality to distribution, let Wasdell take care of your supply chain.

Personalised approach

Wasdell provides true partnership. Our customers appreciate our personalised approach, we become an extension of their team, and even provide hot desks at our sites. We tackle every project with a solution-driven mindset that makes our customers partner with us for the long-term.

Annex 16

On 12 October 2015, Annex 16 Certification by a Qualified Person and Batch Release was published by the European Commission. It is a 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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