What is meant by GxP?
Explanation of the term
The term GxP covers all regulatory requirements for good working practice, also known as Good Practice. These are particularly important in the fields of pharmacy, chemistry and biotechnology. The guidelines in the GxP environment are laid down by bodies including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The aim of the GxP requirements is to ensure consumer safety and product quality, which is why the term GxP often also appears in the context of classic quality management systems. Compliance with the regulatory requirements is verified by the supervisory authority of the respective country in regular inspections.1
Manufacturing
What requirements exist within GxP?
Different product-specific requirements apply in the respective areas of the research and development chain of a new medicine or life sciences product. In addition to the Medical Device Regulation (MDR), the respective GxP requirements are also monitored. These include, among others, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP). These regulatory requirements are intended to ensure quality assurance and data integrity. In addition, they allow companies to operate within a certain scope of action.2
Challenges arising from decentralisation and third parties
A closer look at the market reveals a current trend towards decentralisation and collaborations with third-party companies. The resulting flexibility creates many advantages for companies, but the increasing complexity within the value chain also gives rise to new challenges. Working with partner companies, in particular with contract research organisations (CRO) and contract manufacturing organisations (CMO), makes compliance with the regulatory requirements more difficult. Smooth workflow management with appropriate document management has become indispensable for modern life sciences companies.3