For pharma & biotech

Inspection preparation

Do you want to be well prepared for the GMP or GDP inspection? Then PCS can help you with that. Inspection preparation is the optimal preparation for the upcoming customer audit or government inspection.

This way you know which observations to expect. But during this preparation you will also learn how you can provide the auditor or inspector with the desired information as quickly and as effectively as possible to ensure that the audit or inspection runs as smoothly as possible.

Why you need inspection preparation

Governments have the right to visit companies and check that company for compliance with GMP or GDP regulations. We often find that there is no time, experience or capacity to properly prepare or conduct such an inspection.

Incorrect preparation or execution can lead to unpleasant consequences, such as observations that could have been prevented or an incorrect negative image of the company by the customer or government.

With the inspection preparation you are one step ahead. It is therefore the perfect preparation for a customer audit or government inspection so that the company knows which observation is being made. That way you know what to expect and you don't have to worry about the inspection.

Use the services of PCS for inspection preparation

PCS offers inspection preparation services that consist of five sub-sections:

Trial inspection / mock audit

This is usually the first step in the process: PCS has an independent auditor perform a trial inspection. This trial inspection produces concrete points for improvement that you can work with.

Staff training

Proper preparation of the staff for the type of questions from inspectors or auditors is a must. This way your staff knows what to expect and how to deal with difficult questions. In addition, we train the staff to have documentation ready in time for the inspection or audit.

Check on implementation of improvements

After making the points for improvement during the trial inspection, we naturally want to see that you have started working on the points of improvement. The corrective and preventive actions (CAPAs) should already be implemented as much as possible. We make sure that CAPA implementation is progressing. If this is not the case, PCS will support you in accelerating the CAPA implementation.

On-site during inspection or audit

If you wish, PCS can be present during the inspection or audit. This sometimes reassures you, having extra expertise in the room can be a welcome back-up when difficult topics are discussed. PCS often also helps with an extra person in the back office of the company to deliver documents as quickly as possible. As a rule, documents have to be delivered within 1 minute, which can sometimes be a challenge.

Response to inspection / audit report

Every inspection or audit is different. However, it almost never happens that an inspection results in zero observations. There are always small or large comments from the inspector or auditor. Writing a comprehensive response to a report is challenging. People are too quick to get on the defensive or formulate a response that does not adequately cover the charge. With the unique expertise of PCS and a team of highly experienced consultants, we can help companies write a good response to an inspection or audit report.

Get a free inspection readiness check by one of our experts!

The 10 steps of a mock audit or inspection by PCS

When you choose an inspection preparation by PCS, we go through the following 10 steps.

  • 1 Planning a date
    In consultation with you, adhering to the procedure for the trial inspection or mock audit, we plan a date for the trial inspection.
  • 2 Preparing the mock audit / trial inspection
    We prepare the mock audit / trial inspection by means of a remote audit in which we review and assess a selection of quality system documents. This means we don't have to spend time on-site for this. The remote audit takes an average of two days per factory.
  • 3 Performing the mock audit / trial inspection
    We can audit or inspect multiple factories if necessary. We look at the facility, the processes, the equipment, the people and many other relevant GMP or GDP topics. During the trial inspection / mock audit, we note the findings, discuss them with you and present them at the end of each audit / inspection day. Carrying out the trial inspection / mock audit takes on average between 3 and 5 days per factory.
  • 4 Writing the report
    After the trial inspection / mock audit, a formal report is drawn up. Writing the report takes an average of 2 to 3 days, depending on the duration of the on-site inspection / audit. We write down what the observations are and classify them on the basis of the applicable law/regulations. Observations can be other, minor, major or critical. Preferably you have no critical or major observations. These are very serious shortcomings that can lead to rejects and take a long time to repair. Examples include mold in production areas, lack of cleaning validation of critical equipment or insufficient staff to perform quality checks properly. The report also includes suggestions on how to make improvements following certain observations.
  • 5 Discussing the report
    You have the opportunity to nuance or better explain certain matters in the report. Sometimes an observation is lost in translation. However, the vast majority will remain in effect. During the discussion, timelines and preventive and corrective actions (CAPAs) are discussed. In this we discuss what the action plan is to improve the situation before the real inspection or audit takes place, this conversation usually lasts 4 to 6 hours.
  • 6 Staff training
    We will train your staff on the basis of the report. This takes place in classroom sessions but also on-the-job training. Through role plays and theoretical lectures, challenging situations are discussed to optimally prepare your staff for the upcoming inspection or audit.
  • 7 Coaching QA staff
    We coach the QA staff to be able to deliver documentation on time. This often goes hand in hand with the reorganization of the quality system. If you have a difficult QMS setup the 1-minute rule, within which documents must be on the table in the inspection room, cannot be met. This part is actually a piece of consultancy combined with on-the-job coaching. This takes anywhere from 2 to 14 days.
  • 8 Check on implementation of improvements
    PCS often performs a short half-day or one-day pilot inspection/mock audit to see if a company has implemented all important corrective and preventive actions. This is the last measurement before the inspection. If critical or major points emerge from this, you will have to do everything you can to remedy this.
    If you wish, PCS can be present during the inspection or audit. PCS often also helps with an extra person in the back office of the company to deliver documents as quickly as possible. This support lasts as long as the inspection lasts, which is usually between 1 to 5 days.
  • 9 Responding to the audit- or inspection report
    Writing a comprehensive response to a report is challenging. People are too quick to get on the defensive or formulate a response that does not adequately cover the charge. With the unique expertise of PCS and a team of highly experienced consultants, we can help you write a good response to an inspection or audit report. This support lasts between 1 to 3 days, depending on the number and severity of the observations in the inspection or audit report.
  • 10 Aftercare
    If necessary, aftercare may sometimes be necessary if the inspection auditor has additional questions regarding the response to the audit/inspection report. We can help you with this.

Inspection preparation by the best coaches

PCS often uses the expertise of ex-government inspectors for proper inspection preparation. Although these costs are significantly higher, you will achieve a high return because the preparation and trial inspection / mock audit is carried out at the highest level. This gives you a good idea of how an inspector thinks, what he/she looks at and what the seriousness of the shortcomings is.

In most cases, the PCS office works hard to put certain things that are missing in order. This saves you a lot of time. Think of improving documents, putting them in the right layout or adding documents to the quality system that were previously missing.

Why choose PCS for inspection preparation?

PCS has a lot of experience in the field of government inspections and customer audits. We mainly work with former government inspectors and auditors who have audited more than 300 companies themselves.

We know both sides of the story and focus on the essentials. This guarantees you a solid preparation and the best possible outcome.

Thanks in part to PCS's international customer base, we can prepare companies for any type of inspection: EU GMP, U.S. FDA, PIC/S or WHO GMP; or a combination of these. We know what companies or government expects and what they are going to inspect.

Get started with inspection preparation