GxP stands for Good [x] Practices. “x“ can be any of at least 20+ possibilities according to a Wikipedia search of the term. GxP is applied in many fields, as for example in business, agriculture, logistics, life sciences and others.
In this post, we focus our attention to GxP as it relates to the life sciences industry. We try to clarify some commonly used terms that encompass the acronym ‘GxP’ and to provide general helpful information, so the reader can grasp the meaning of the terms and then investigate in further detail on specific topics of GxP as needed.
1. What does GxP stand for in the life sciences industry?
In the life sciences industry, which includes pharmaceuticals, medical devices, agriculture, food products, cosmetics and nutraceuticals, GxP stands for: Good [x=Manufacturing, Laboratory, Clinical, Documentation, Automated Manufacturing] Practices. Accordingly, we have GMP, GLP, GCP, GDP, GAMP, respectively. Often we see the term “cGMP” or “cGCP”. The small letter “c” applies to all of the above acronyms and denotes that these practices are current. The regulations for GxPs are also referred to as the “predicate rules”.
2. What is a “Good Practice”?
A good practice is a way of doing something that is regarded as superior, more reliable and consistent with other related ways of doing the same thing. For example, a good pharmaceutical product manufacturing practice is in conformance with, or complies with regulations by the health authorities. Such practices are often performed by trained personnel and in the case of the life sciences industry, they are designed to provide assurance of product quality, data integrity and ultimately, patient safety.
3. What is the purpose of GxPs?
GxPs define the requirements for compliance with regulations. So, once we have read and understood the applicable regulations, then we can create appropriate procedures, implement appropriate controls and execute good practices in order to conform to regulations. These are some of the things inspectors are looking for when they come to a regulated organization for an audit.
4. What are GxP data?
Companies in the life sciences industry manufacture, verify and distribute products destined for human consumption. Data are constantly being generated throughout these processes – paper-based and electronic in form. In a regulated and controlled environment these data must follow certain regulations to ensure their integrity, access, collection, archival and to prevent its manipulation by unauthorized users. Laboratory and manufacturing data, data from clinical studies, patient data, quality assurance metrics data are just a few types of data that are considered critical or sensitive and must be handled with extreme care. Collectively, these are called GxP data.
5. What is a GxP environment?
GxP environment is an interconnected milieu of software, hardware, operating procedures and people, controlled functions or processes, equipment, facilities, and the interfaces with which regulated systems interact with one another. Additionally, in a GxP environment regulated users and owners of computerized systems that collect GxP data, have clear responsibilities as they pertain to GxP systems, maintain the validated status of computerized systems and have the required policies describing these responsibilities. In short, everything within the GxP environment should comply with industry regulations, follow appropriate guidelines and is audit-ready for regulatory inspections according to the PIC/S Guidance.
6. What is a GxP system?
A GxP system is most often a computerized system that collects and/or stores GxP data and that operates in a regulated environment. Examples of such systems are QMS, Electronic & Clinical DMS, LIMS, ERP, MES, statistical systems and systems that use ERES. Inspectors want to see that GxP systems are operating in a controlled manner. Therefore, it is a “good practice” to validate these systems and their associated software so they comply with industry regulations. There are several categories of computerized systems according to GAMP5. Each system needs to be well assessed, in order to assess and determine the appropriate validation effort required. CSV experts can provide support in all these validation activities.
7. What is a GxP project?
A GxP project is one that involves GxP data controlled by a GxP system, which in turn is operated in a GxP environment. Examples of such projects are computerized system validation (CSV) of a GxP system, performing risk assessments to gauge the criticality of the system, it’s impact to the business, or the validation effort required to validate the GxP system. Moreover, completing an information security assessment, upgrading a software version used in a GxP system, re-validation of a GxP system, migration of GxP data from or to a GxP system and decommissioning a GxP system from use are also considered GxP projects.
8. Where can one find GxP regulations or guidelines?
One can find guidance to applicable regulations in the FDA, FDA ERES, MHRA, EMEA, EU Annex 11 and WHO websites. These are the leading authorities in the world regarding GxPs in the life sciences industry. There are several industry guidelines published periodically that attempt to clarify the regulations and make them easier to understand by giving examples, templates and other helpful material. The best ones are those offered by the ISPE’s GAMP5 group, ECA, ICH, PIC/S, ISO and ASQ.
9. What are the main themes of GxP compliance?
The main themes of GxP compliance are traceability and accountability; These two terms cope with whether product manufacturing information can be traced back in time and whether persons that contributed to the manufacturing of product can be identified, respectively.
10. How does one ensure GxP compliance?
Much can be written here, but will try to keep it short for the purposes of this post.
According to the life sciences Quality Assurance departments, the current rule of thumb is: “if it was not documented, it didn’t happen”. Good Documentation Practices (GDP) can be achieved in a controlled paper-based manner, as well as in a controlled electronic form. So, always document test results, (e)sign and date documents, obtain signed reviews and approvals, do not destroy data at will, retain training records and always respect and follow user access rights and privileges. These basic GDP rules should form the foundation towards achieving GxP compliance. Remember to use ALCOA for GDPs; an acronym, which stands for: Attributable, Legible, Contemporaneous, Original and Accurate. GMP, GLP and GCP (see point #1 above) possess further obligations according to the associated regulations, such as Quality by Design (QbD) during product manufacturing steps. Basic traceability and accountability requirements can be met following these practices.
Further ways to demonstrate compliance to GxP is to validate computerized systems, follow written and approved standard operating procedures (SOPs), perform periodic reviews of critical processes, implement controls in order to identify errors as they occur, implement preventive and corrective actions, follow the guidelines for data integrity, disaster recovery & business continuity and last but not least always try to abide by the industry’s current regulations.
Summary
These 10 answers to frequently asked questions about GxP, should better prepare one to not only face the GxP area, but to excel within it as well. For more detailed information on GxP in the life sciences industry, or for further details to the answers provided in this post, contact us and we will be glad to assist.