Outsource your GMP and GDP audits to PCS. We audit pharmaceutical suppliers against the GxP's, worldwide. Get insight into the qualification of your suppliers through PCS' audit services.
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We conduct detailed GxP audits of your external suppliers.
We find current and future problems and help you determine potential risks in your pharmaceutical supply chain.
Clients ask us to qualify suppliers and contractors in the pharmaceutical and biotech industries against the GxPs. Our audit services are global and design every major regulatory framework, including the EU GMP, EU GDP, EU GLP and EU GCP guidelines. The U.S. FDA guidelines and WHO GMP requirements.
PCS can audit individual suppliers or assume full responsibility for your entire supplier qualification program.
Pharmaceutical CMO's (contract manufacturing organizations),
API and excipient manufacturers,
Distribution and warehousing organizations,
Intermediates,
Service providers,
Contract laboratories.
PCS prepares the audit, carries it out and reports it directly to the client. The focus of the audit is determined by the client and can include (for example); due diligence, for-cause, after a complaint, routine, self-inspection, etc. If desired, PCS can recommend and assess CAPAs after an audit.
PCS has a large team of qualified GxP auditors. With extensive experience in running international audit programs. We have organized and executed corporate audit programs for a number of multinationals like Sandoz, Novartis and Norgine International.
Auditing in the pharmaceutical industry ensures compliance and product safety. Effective auditors must blend theory with a keen understanding of human behavior to assess adherence and inspire commitment to quality standards.
Looking to outsource the management of your third-party audits? PCS has managed the audit program of a number of pharmaceutical organizations such as Novartis, Sandoz, the Dutch Ministry of Health and Norgine. We can assume the entire supplier qualification program, or part thereof.
Besides audits of suppliers, PCS can perform a gap analysis of your organization against every major regulatory framework. The scope of the gap analysis determines the scope. You have the option to choose between a "regular" auditor or an ex-regulatory inspector from the EU or the U.S. FDA.
Gap assessments usually last between 1 to 3 days and are concluded with a comprehensive report. Depending on your requirements, PCS may also assist with CAPA definition and recommendations.
All gap assessments are performed by seasoned industry & regulatory experts.
This depends per audit, but in general PCS only works with auditors with at least 10 years of experience. Our auditors are qualified auditors.
PCS has performed more than 550 GMP/GDP audits since 2010, mainly of suppliers of Active Pharmaceutical Ingredients and logistics providers (3PL's).
This mainly depends on the size of the manufacturing facility and the cause of the audit. Large manufacturers may take up to three days. While small facilities receiving a regular qualification audit may only need one day. On average, our audits require 1 day within the EU, outside the EU the average duration is 2.5 days.
PCS can perform GMP/GDP audits worldwide, with notable exceptions being Russia, North Korea, Syria and Afghanistan. All other countries can be serviced by PCS team members or associates. In the EU, besides GMP and GDP audits, PCS can perform GCP and GLP audits as well.
We would first request a few details from you including; 1. the reason for the audit, 2. the auditee's location, 3. the product the auditee produces for you, 4. the scope and the timeline. With this information, PCS will produce an offer for review. This offer will contain all the costs, the timeline, the deliverables and the auditor. If desirable, a call can be planned with the auditor in advance. Once the offer is signed, the audit is prepared by requesting documents from the auditee such as the SMF, QM, etc. The auditor will travel to the site, perform the audit and conclude with a summary. Within 21 days, the full audit report will be sent to you for review.
We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a GMP audit or a GDP audit? We have the expertise and experience to help you perform these audits. Feel free to contact us if you have any questions about our audit services or GMP/GDP in general.
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