Regulatory inspection readiness support
EU GMP, U.S. FDA or WHO GMP inspection preparation support. Ensure your team and facility are ready with PCS’ inspection support services.
Over 100 satisfied clients preceded you!
PCS has 33 years of experience in helping pharmaceutical companies get ready for regulatory inspection. This often includes a GAP assessment of the Quality Management System (QMS/PQS) and strengthening the organization to enable prompt and accurate responses to any regulatory inquiries.
PCS has intimate knowledge of the U.S. FDA, WHO and EU GMP. We can tackle complex environments, apply broader knowledge than local consultants and identify any GAP’s between regulatory requirements and your current situation. You will be provided with well-founded CAPA recommendations (and implementation) to optimally prepare for any regulatory audit.
Curious to see how we can help you with inspection preparation? Plan a free consult today!
We help pharmaceutical companies upgrade their QMS and process(es) to regulatory standards. Not by simply re-writing SOP’s but by assessing the organization as a whole against modern regulatory requirements. This includes your process(es), QMS, managerial involvement, quality culture, data integrity and human resources.
The regulatory frameworks we support with our inspection readiness services;
- EU GMP inspection preparation,
- EU GDP inspection preparation,
- U.S. FDA GMP inspection preparation,
- WHO GMP prequalification & inspection preparation.
- 1 Connect you to an experienced consultant
- 2 Face-to-face or online meeting
- 3 PCS drafts an action plan
- 4 Offer sent & accepted?
- 5 PCS starts working!
- 6 Ready for regulatory inspection
Let me help you explore all the benefits of our services!
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 our inspection readiness services you are one step ahead. It is the perfect preparation for a customer audit or government inspection. You know what you can expect, your weaknesses, strengths and how the government inspects your facility.
PCS offers a number of inspection readiness services. Clients can choose which service(s) best suit their current situation. The inspection readiness services PCS offers are:
This is usually the first step in the process: PCS has an independent auditor perform a mock audit. This mock audit results in a comprehensive audit report, with points of improvement that can be developed into CAPA’s.
The CAPA’s defined after the mock audit should be implemented. PCS will check on the implementation, help where needed – and provide project coordination support to ensure all deadlines are met.
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 supplies an extra consultant to coordinate with your back office to deliver the right GxP 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.
Proper preparation of the staff for the type of questions from inspectors or auditors is a must. After the training your staff will know 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.
PCS uses the expertise of ex-EU GMP/EU GDP, U.S. FDA and WHO GMP inspectors for proper inspection preparation. Using these highly experienced professional results in a significant boost in your readiness level as the preparation and mock audit are carried out knowing what the government expects and inspects.
PCS has extensive experience in the field of regulatory GxP inspections and customer audits. We mainly work with ex-EU GMP, EU GDP, former U.S. FDA and WHO GMP inspectors as well as 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.
