GxPs are standardized practices defined for drug companies that research, produce, store, distribute or sell pharmaceutical products. GxPs refer to a collection of quality standards and guidelines that are designed to ensure that the safety of the products is maintained across the product lifecycle. While there is no single framework for GxP guidelines and regulations, some of the common regulators include FDA in the US, TGA in Australia, and HC-SC in Canada.
There are different types of GxPs that Pharma companies must follow, which span across:
Good Manufacturing Practices (GMP)
GMPs are the standards established by Agencies that regulate the manufacturing processes of pharmaceuticals. The guidelines outline minimum specifications that manufacturers must follow to mitigate the risks involved in any pharmaceutical manufacturing process.
The GMPs address the key points to consider in drug manufacturing, for instance:
- Facilities are in good shape and are of the proper scale
- Machinery is in working condition and well-maintained
- Employees have the requisite expertise and preparation they need
- Processes are consistent and reliable
- Correctly sourced materials, equipment and logos are used
Good Distribution Practices (GDP)
Good Distribution Practice (GDP) defines the minimum requirements that must be met by a wholesale distributor to maintain the quality and integrity of the medicines across the supply chain. GDP is supervised and regulated by global and national directives in the same way as GMP.
The following are assured by GDP systems:
- Supply chain medicines are approved under the European Union (EU) laws, which are among the most stringent
- Medicines are processed in acceptable conditions and transported
- The inventories are correctly rotated
- Facility systems should allow employees quickly to detect and retrieve objects if needed
- Contamination of other goods is prevented in all cases
Apart from GDP and GMP, pharma companies must also practice GxPs like, cGMP (Current Good Manufacturing Practices), GCP (Good Clinical Practice), Good Laboratory Practice (GLP), GPvP (Good Pharmacovigilance Practice), etc.
Therefore, it is necessary for the organizations to approach a dedicated and established Regulatory consulting team for successful compliance.