How to prepare for an inspection

What does an ideal inspection look like?

1. Information

As a first step, it is important to inform management and all employees associated with the business unit of the nature, scope and date of the upcoming inspection as soon as it is known.

2. Forming a team

For the next step, different teams should be formed (the size of the team depends on the size of the inspected company). The core team is usually led by the Quality Assurance department or directly by the GMP Lead (RP) who manages the preparation and focus tasks, coordinates contacts and reports directly to senior management.

3. Gap analysis

During the preparation process, all facilities, equipment, systems and documentation are analyzed for possible deficiencies. The quality assurance department or GMP leader should provide support for the relevant facilities and areas. Areas for improvement should be identified and, if possible, measures should be taken. If they cannot be eliminated before the inspection is due, the problem should be described and an action plan developed. In this way, it can be demonstrated to the authorities that the deficiencies have been identified and addressed.

Mock inspections may be helpful

4. Document preparation

The following documents and summaries should be prepared and available at the time of inspection:

Organization Chart

Job Description

Training documents

Important SOPs (e.g. personnel, hygiene, deviation management, compliance and recall handling, returns handling, change control, etc.)

Layout and overview (including technical equipment such as HVAC systems)

Listing of pf products

Verification and validation documentation

Summary of deviations, complaints and recalls

5. Detailed plan

Depending on the size of the operation, the following functions need to be identified:

Inspection management: the main person in contact with the inspector, coordinating the inspection (usually RP or QA department personnel).

Specialist (SME: Subject Matter Expert): specializes in a particular area and is prepared to answer relevant questions raised during the inspection.

For large companies/inspections:

Inspection coordinator: head of the coordination room, coordinates the inspectors' questions, assigns experts to answer and oversees all documentation.

Scribe: records the progress of the inspection, records questions and inquiries from the inspectors, and records the processing.

Transmitter: transmits questions from the inspection room to the coordination room.

6. Training

Another important component is the training of all personnel involved in the inspection. All personnel involved should receive specialized training.

7. Start of inspection

To avoid surprises, the duration, scope and schedule of the inspection should be determined at the outset. Senior management gives a short presentation of the company with no more than 10 slides. This not only saves time, but also provides the inspector with important information and has the potential to give a positive first impression. Applicable safety and health regulations can also be addressed here.

Link to original article:https://mp.weixin.qq.com/s/iIDQpeDRDz7clDr2nGHjaQ