The QMS defines the processes and responsibilities within the scope of the WDA(H) and must incorporate risk management principles.

The quality system should be proportionate and effective for the size, structure and complexity of activities. The Responsible Person and the organisation’s management are responsible for the quality system.

The WDA(H) application is broken down into two stages:

1) Registration: MHRA verification of the company

2) Application: Covering aspects of the proposed operations, including scope, named personnel and third parties. All sites used for the WDA(H) activities need to be named on the authorisation, even if no physical product is handled there.

A minimum of one Responsible Person should be named on the application. A Responsible Person for Import should also be named where required.

A site GDP inspection will be scheduled by the MHRA. The inspection will assess GDP compliance and the ability of the company to remain compliant under the scope of its WDA(H).

Any deficiencies found are classified and outlined in the closing meeting and subsequent post-inspection letter.

The Company is expected to provide a written response to the deficiencies, detailing the proposed corrective actions and a timeframe for their implementation.

The inspector will evaluate the company’s responses and assess the proposed plan(s). Once satisfied that the site is compliant or in the process of resolving all deficiencies, the inspection report and GDP certificate are then finalised, and the WDA(H) can be granted.

Our Quality team can evaluate your licence requirements, help to create and qualify your supply chain, build your GDP-compliant quality management system, support with the WDA application process, and provide both RPs and RPis to be named on your licence.

To find out how we can help you, get in touch at consultancy@jensongroup.com.