Managing inspections is a very nervy process but if planned out carefully may not be as daunting as often believed.
Part part of the reason there are problems, is down to the fact that companies do not have a good organizational plan. This is a key point which can make or break the inspection experience. Given its importance, the plan should have a structured level and set out clearly what documents should be helpful.
It’s a good idea for the inspection team to have a pre-meeting or series of meetings to go over the key points that might be deemed relevant by the inspectors. This could be exposure points, key inspectional trends, known weaknesses or potential gaps. Although this is not all-inclusive, it helps to make the point about why one needs to do this as part of the process.
So, the first part is to define the issues, then how you plan to defend or address these issues and then what resources will be required for this process. In other words, this creates the need for a structure otherwise the experience will be a chaotic mess.
In brief, the keys of the preparation process will be to:
- Define these issues and split them into different categories as appropriate. This can be developed based upon criticality, risk or some other grouping such as a result of an ongoing failure.
- Arrange a hierarchical organization to handle the various tasks. This should include:
- Whom will manage the inspection face-to-face with the inspectors?
- Key subject matter experts to address specific technical questions
- Whom will manage the document library?
- Whom will act as a scribe to record the points/questions asked together with responses
- Whom will act as escorts for the inspection?
- Whom will manage the communications between the inspection room and the library (often called the war room), where the documentation is kept?
- What technology will one employ to facilitate the inspection process.
- Decide what documents may be required to address the points you’ve raised/issues.
- Taking the control of the documents as a specific issue is addressed
As a rule, it’s best to prepare hard copies of all the key documents that an inspector would want to see. Such things include: SOP, policies, work instructions, validation records, testing results, chromatography charts and investigations. These could be arranged in the form of a library on portable carts for ease of movement in and out of the review area that’s been set up for the inspection.
So, using technology or hard copies, as documents are called for review, a runner delivers them to the inspection room. In all cases these should be numbered, categorized and logged for future review and learning. This is important, because this process should always be a continuous learning opportunity.
This is just one piece of the process, intended to highlight the process, but the principles are the same, and a structure needs to be developed and followed with discipline if one can realistically expect a positive outcome.
For some organizations this can be a process/situation where a talented GMP consultant can add value. Our advice here is don’t undertake this inspection process preparation without a good coach, and even if you are experienced, it may still be worth asking for and outside “look and see “set of fresh eyes to determine if your approach is still appropriate and/or current.