The concept of GxP requirements in the pharmaceutical and food industries was established by the United States Food and Drug Administration. It refers to a set of quality guidelines and regulations that aim to make sure pharma and food products are safe and meet their intended use.
GxP regulations apply to the cosmetics, medical devices, or food industries as well, but this article focuses on the applications of GxP in pharmaceutical product development. Simply put, x is a variable which could be replaced by M for “Manufacturing”, C for “Clinical”, D for “Distribution”, L for “Laboratory”, S for “Storage”, A for “Auditing”, etc.
Why we need Good Practices
The purpose of GxP is to ensure that the product (drug) under development meets requirements and is fit for the intended use. In highly regulated industries, applying relevant GxP process regulations is a must. If you’re operating in one of these industries, chances are you’ve already encountered some of them.
The main concepts that all GxP regulations share:
- Traceability: the ability to reconstruct a product’s entire lifecycle history, as well as that of each and every work item that contributed to its development.
- Accountability: knowing who was involved in the product’s development, including when and how exactly did they contribute.
- Data integrity: your chosen method for Quality Management produces reliable, consistent data.
Let’s dig one level deeper and learn about the relevant practices in pharma project management. While different industry sectors may need to use different practices, these are the most common ones:
- GMP (GAMP) - (Automated) Manufacturing
- GDP - Distribution
- GLP - Laboratory
- GCP - Clinical
Applying to the manufacture of drugs, GMP stipulates that contributors to the process (including manufacturers, processors, packagers, and assemblers of pharma products) take the necessary proactive measures to ensure the safety, purity, and effectiveness of their products.
GMP addresses issues around cleanliness, valid process usage, handling complaints, sanitation, hygiene, record keeping, and personnel qualifications. GMP guidelines aren’t prescriptive, meaning that they allow manufacturers to figure out how to best implement them in their specific environments.
Good Automated Manufacturing Practices are essentially the automated reconstruction of GMP. The ISPE GAMP® 5 Guide became the accepted industry guidance worldwide for GxP computerized systems management.
This technical document guides companies in taking a risk-based approach to creating scalable, verifiable computerized systems while achieving or maintaining compliance with regulations.
To help adhere to GAMP® 5 requirements, Intland Software has implemented compliant processes in a template so you needn’t worry about missing any elements of it. Access our brochure to learn more about Intland Retina’s Pharma GAMP® 5 Template!
GCP is an international standard by the International Conference on Harmonisation (ICH). It is relevant in clinical trials where human subjects are involved.
GCP requires companies to follow certain protocols to ensure that subjects’ rights, wellbeing, and safety don’t get violated. All possible risks have to be addressed and measured against the possible benefits. GCP focuses on the moral aspects of clinical trials, stipulating that the interests of corporations are not to be prioritized above human life.
“2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.”
Good Laboratory Practices apply to non-clinical safety tests in research labs. In essence, GLP requirements aim to ensure the consistency, reliability, reproducibility, quality, and integrity of human or animal health products via non-clinical safety tests.
The main principles of GLP are the following:
- Safety testing and risk management are applied to medicines, cosmetics, veterinary drugs, food additives and industrial chemicals
- Organization and personnel: responsibilities for management, sponsor, study director, principal investigator, study personnel are clearly defined
- Everything is researched, developed, traced, and tested under a certified Quality Management System (ISO 9001)
- The reporting of results cannot be manipulated or changed
- Requirements on archiving storage of reports and records.
The European Union has very strict guidelines on the distribution of medicinal products, GDP for short. It describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
Complying with it ensures the following:
- Medicines in the supply chain are authorised in accordance with European Union (EU) legislation
- Medicines are stored and transported in suitable conditions
- Contamination is avoided in all circumstances
- There’s an adequate turnover of stored medicines
- The right products reach the right addressee within a suitable time period
- The distributor implements activities to find faulty products.
One possible solution to applying the above principles and achieving compliance is using a holistic Quality Management System. Such software platforms enable the use of custom workflows in a modern and collaborative electronic environment, and can help automate the documentation of processes. This minimizes the human error factor which is the main cause of failure at audits.To learn more about a widely applied solution for Quality Management, check out Intland Retina’s pharma-related capabilities!