What is GxP? Well, the answer depends, because GxP becomes very specific depending on which ‘x’ value we are talking about, and which industry. For example, the US FDA requires very specific GMP requirements that differ from those of the EU and other countries. Drugs approved or synthesized without US FDA certification cannot be legally sold in the US. Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries.
But GxP is not just for Life Sciences; it covers many heavily regulated industries, since at its core GxP is a general abbreviation for the "good practice" of quality guidelines and regulations. The "x" stands for the various fields. In Life Science, these include good manufacturing practice (GMP), good clinical practice (GCP) and good agricultural practice (GAP), to name a few.
In India, for example, Good Manufacturing Practices (GMP) standards for medical devices and drugs are covered in Schedule M and Schedule M III of the Drugs and Cosmetics Act (DCA). Schedule M describes the quality assurance, self-inspection and/or quality audit and quality control system requirements for medical devices and pharmaceuticals. It also lists the requirements for the factory premises, materials, plant and equipment. As is becoming more common, these requirements are based on World Health Organization guidelines. And for drugs, there also are additional, specific requirements for small volume injectables, large volume parenterals, APIs, tablets, capsules, etc. India’s GMP regulations are now more aligned with ISO 13485.
Good Clinical Practice (GCP) is an international standard set for conducting, formulating, documenting, and reporting clinical trials that may involve humans as participants. The ICH GCP (International Conference on Harmonization of Good Clinical Practice) provides a uniform standard for US, the European Union and Japan to facilitate the adoption of clinical data by regulatory authorities of the said jurisdictions. These guidelines should be followed when data from clinical trials will be submitted to regulatory authorities. The Indian version of GCP is based on the ICH-GCP, but there are key differences between the two. Some of the guidelines found in the Indian version result in difficult methodology which becomes overwhelming for sponsors and investigators. As you can see, different domains and different regions will follow different GxP practices.
Here are a few of the more common values for ‘x’ –
- Good agricultural and collection practices, or GACP(s)
- Good agricultural practice, or GAP
- Good auditing practice, or GAP
- Good automated laboratory practice, or GALP[2][3]
- Good automated manufacturing practice, or GAMP
- Good business practice, or GBP
- Good clinical data management practice, or GCDMP
- Good clinical laboratory practice, or GCLP
- Good clinical practice, or GCP
- Good documentation practice, or GDP, or GDocP (to distinguish from "good distribution practice")
- Good distribution practice, or GDP
- Good engineering practice, or GEP
- Good financial practice, or GFP
- Good guidance practice, or GGP[5][6]
- Good horticultural practice, or GHP
- Good hygiene practice, or GHP
- Good laboratory practice, or GLP
- Good manufacturing practice, or GMP
- Good microbiological practice, or GMiP
- Good pharmacovigilance practice, or GPvP or even GVP
- Good pharmacy practice, or GPP
- Good policing practice, or GPP
- Good recruitment practice, or GRP
- Good research practice, or GRP
- Good safety practice, or GSP
- Good storage practice, or GSP
Each of these has published guidelines, which will vary by industry and region. In Life Sciences, along with Aviation and Financial Services, there are usually regulations that must be complied with. Regardless, where GxP is used, there are three key pillars to all GxP models. These are considered essential to ensuring the quality and safety of the final product. They are: Traceability, Accountability and Data Integrity. Another principle of GxP are the 5P’s; People, Procedure, Products, Premises and Process. It is almost as if the 3DEXPERIENCE platform was built to respond to GxP as a way of doing business. Offerings like License for Quality and Quality Incident & CAPA Management address key GxP needs for customers across multiple areas.
For additional insights, you can follow the links below,
https://ifwe.3ds.com/life-sciences/pharmaceutical-and-biotech
https://ifwe.3ds.com/life-sciences/medical-device
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