23/24 February 2021
GDP inspections by supervisory authorities have grown in number and intensity since the EU-GDP Guidelines were published in 2013. Passing successfully also influences business factors; the issuing and renewal of a wholesale distribution authorisation (WDA) for example requires a successful GDP inspection. Many partners in the distribution chain also have customer audits to face.
What does the ideal preparation look like?
As one of the first steps, it is important that the management and all staff members of the business units concerned are informed about the nature, scope and date of an upcoming inspection as soon as it is known.
2. Team formation
For the next step, various teams should be formed (the size of the teams depends on the size of the company/ site to be inspected). The core team, usually led my the quality assurance unit or directly by the Responsible Person for GDP (RP), manages the preparations and prioritises tasks, coordinates the contact persons and reports directly to senior management.
3. Gap analysis
While preparing, all facilities, equipment, systems and documents are analysed for possible deficiencies. The quality assurance unit resp. the RP should support the facilities and areas concerned. Need for improvement should be identified and, if possible, derived measures should be taken. If the elimination is not possible before the inspection is due, the problem should be described and an action plan should be developed. This way, it can be proven to the authority that the deficiency has already been identified and addressed.
4. Preparation of documents
The following documents and summaries should always be prepared and to be supplied during an inspection:
5. Detailed planning
Depending on the business size, the following functions need to be determined:
Another important component is the training of all persons involved in an inspection. All persons involved should be specifically trained for their tasks.
7. Beginning of inspection
To avoid surprises, the duration, scope and agenda of the planned inspection should be addressed at its beginning. A short presentation by senior management of not more than 10 slides introducing the company resp. the site does not only save time, but also supplies the inspector with important information and a possibility to make a positive first impression. The applicable safety and hygiene regulations may also be addressed here.