PCS can perform GMP and GDP audits of your suppliers worldwide. With our team of experienced auditors we can be efficient, cost-effective and are familiar with any regulatory body and its requirements.
GMP requires suppliers of API's (Active Pharmaceutical Ingredients) to be audited by their client. Since 90% of all API's are sourced from India and China, auditing in these countries can be challenging. Regulatory authorities do not consider ISO, GMP or other certificates to be sufficient proof of quality, as such you are required to perform an audit regularly.
GMP requires you to only use suitable excipients. These excipients must meet the latest IPEC regulations. Most manufacturers of excipients have a ISO 9001 Quality System and require special care when auditing. PCS has experts which are familiar with the requirements for excipients and can perform expert audits of these suppliers.
These suppliers have been audited by PCS in the past (not limited to).*the names of these companies are not kept up to date and may not represent the current situation.
GMP audits of suppliers are an essential tool in supply chain control and many companies currently face the challenge of managing an increasingly extensive and demanding audit program, while keeping the cost under control. This requires an efficient approach to the program and the input of experienced and knowledgeable GMP auditors. View our team of experienced auditors.
Pharmaceutical companies are facing an ever-increasing amount of regulatory pressure from the US-FDA, EMA, WHO and other national regulatory authorities. These regulatory authorities regularly conduct inspections that can lead to a halt in many areas such as production. We believe in preventative measures that can save your company painful GMP repair projects and as a result: save time while you maintain focus on revenues, rather than crisis-management.
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A further advantage of our GMP auditing services are that our methodology, reporting and timeline can be adapted to suit the specific needs of your company. This way PCS can ensure that all auditing activities are in full accordance with the client's wishes and requirements.
If a larger number of companies (suppliers) need to be audited, it can be financially advantageous to have PCS perform the planning, communication, auditing and reporting.
We have already delivered an impressive amount of audits and assessments for companies around the globe.
We are a dedicated team of GxP experts who know all ins and outs of Quality Systems and its potential issues.
Our GxP experts work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
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