【ECA新闻】如果准备GDP检查

beiwei5du

05.04.2018

How to prepare for an inspection?

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?

1. Information

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:

• organisation overview and chart,
• job descriptions,
• training documentation,
• important SOPs (e.g. on personal, hygiene, deviation management, compliant and recall handling, handling of returns, change control, etc.),
• layout plans and overviews (also for technical equipment such as HVAC systems),
• list pf products,
• validation and qualification documents,
• summary of deviations, complaints and recalls,
• process of handling suspected counterfeits.
  

5. Detailed planning

Depending on the business size, the following functions need to be determined:

• Inspection management: main contact person for the inspector, co-ordinates the inspection (usually the RP or a representative of the quality assurance unit);
• Experts (SME; Subject Matter Expert): representatives of each area are prepared to answer questions on the issue in question;
• For large companies/inspections:
  - Inspection coordinator: lead of the coordination room, coordinates the enquires, appoints experts and supervises all documents;
  - Scribe: records the progress of the inspection, writes down questions and enquiries of the inspectors and documents their processing;
  - Runner: delivers enquiries from the inspection room to the coordination room.
  

6. Training

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.

syhorchid

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预知子

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08111832187

process of handling suspected counterfeits.这条企业如何实施？相关的控制措施描述在SOP中然后呈现给审计官吗？ 谢谢

小金库

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