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Inspection Readiness

Be optimally prepared for your upcoming GMP or GDP inspection using PCS' inspection preparation services.

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Abbott
Roche
Pfizer

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Why choose PCS for inspection preparation services?

  • Extensive experience in GxP audits and regulatory inspections
  • We work with ex-EU and US FDA government inspectors
  • More than 30 years of experience in GMP and GDP
  • We have a 98% success rate in the Netherlands, our home market

Inspection preparation

Expecting an upcoming GMP or GDP inspection? PCS can help you prepare. Inspection preparation is the optimal preparation for the upcoming customer audit or government inspection.

Using our services you can improve beforehand and know what observations to expect, for items that cannot be improved in time. 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.

How you can benefit from 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 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 observations to expect. That way you know what to expect and worry less about the outcome of the regulatory inspection or audit.

Jaap Koster, CEO of PCS, avatar

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 governments expects and what they are going to inspect.

Eng. J.J.M. Koster
CEO of PCS

Use PCS' inspection readiness services

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

  1. Mock audit (or inspection)

    This is usually the first step in the process: PCS has an auditor perform a mock inspection. This mock inspection produces concrete points for improvement that you can work with. In addition, your team now knows what they can expect and what type of questions the inspectors or auditor will ask.

  2. CAPA definition and implementation To remediate the observations from the mock audit, we help your team set-up a solid CAPA plan and monitor it's implementation.

  3. Training If more training is needed on top of the mock audit, PCS can provide specialized inspection readiness training.

Get prepared for an inspection 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.

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Frequently asked questions

Why is Inspection Readiness important in the Pharmaceutical Industry?

Inspection readiness is crucial in the pharmaceutical industry as it ensures that companies comply with stringent regulatory standards. This compliance is essential for maintaining product quality, ensuring patient safety, and avoiding costly penalties or operational disruptions due to non-compliance.

How does PCS assist in preparing for regulatory inspections?

Our company offers comprehensive services that include reviewing and optimizing quality systems, conducting internal audits, providing staff training, and conducting mock inspections. We tailor our approach to meet the specific needs of each client, ensuring thorough preparation for any regulatory inspection.

What kind of expertise does your team bring to Inspection Readiness?

Our team consists of experienced professionals, including ex-regulatory inspectors, with extensive knowledge in pharmaceutical regulations, quality assurance, and compliance. They are adept at identifying potential issues and implementing strategies to address them effectively, ensuring your company is well-prepared for inspections.

Can your services be customized to specific needs of my company?

Absolutely. We understand that each pharmaceutical company has unique needs and challenges. Our services are highly customizable, allowing us to focus on specific areas of concern and provide tailored solutions that best fit your company's requirements for inspection readiness.

How can we help?

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.

  • Extensive experience in GxP audits and regulatory inspections
  • We work with ex-EU and US FDA government inspectors
  • More than 30 years of experience in GMP and GDP
  • We have a 98% success rate in the Netherlands, our home market
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