GxP EXPLAINED
GxP refers to the ‘good practice’ guidelines and regulations created to ensure that drugs, medical devices, food and other products are safe, effective and usable.
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The ‘X’ in GxP can refer to a number of disciplines
GMP - Good Manufacturing Practice
GAMP - Good Automated Manufacturing Practice
GLP - Good Laboratory Practice
GPVP - Good Pharmacovigilance Practice
GDP - Good Distribution Practice
GdocP - Good Documentation Practice
Together these disciplines define the various ways companies in regulated industries are required to control their processes, procedures, people and premises to ensure consistency and quality in their products.
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GxP is about controlling the processes by which your products are developed, manufactured and handled in defined ways throughout the supply chain - ensuring they are of consistent quality and can be used safely:
Why is GxP compliance so important?
Due to the potential risk to human health of the products the DEA, FDA and other regulatory bodies oversee, the powers of the regulators in these sectors are far-reaching.
GxP compliance is monitored and enforced by agencies and government bodies through certification requirements, regular inspections and unannounced auditing.
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For this reason, regulators often require companies to verify and vouch for the GxP compliance of their partners throughout the supply chain.
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As a result more and more companies are finding they need to adopt GxP - and prove they have adopted them - to protect their markets, supplier status and future business.
