Do you want to be well prepared for GMP or GDP inspection? PCS can help you prepare.
For pharma & biotech
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.
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.
PCS offers inspection preparation services that consist of five sub-sections:
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.
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.
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.
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.
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.
When you choose an inspection preparation by PCS, we go through the following 10 steps.
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.
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.