GxP compliance for the pharmaceutical industry is an important aspect, but what is GxP, and how do you comply with it?
If your company works in a highly regulated sector such as pharmaceuticals, you have probably come across the idea of good practice (GxP). The Food and Drug Administration created GxP enforcement laws in the U.S. (FDA).
What is A GxP?
The ‘x’ stands for the specific sector, whether it is output (GMP), distribution (GDP), laboratory (GLP), etc. They aim to ensure that companies operating in controlled industries produce safe and fit for use during the entire manufacturing process, following strict quality standards.
In general, the rules are identical from country to country, and each nation has its regulator. But the FDA’s criteria are king for many manufacturers-the U.S. market is the world’s largest, and therefore the most lucrative.
The two main objectives of the standards and regulations of GxP are to bring transparency and traceability to any pharmaceutical company project. Although GxP compliance for pharmaceutical IT and information control systems must always be validated by specialists, some basic GxP assessment questions must recognize all involved in creating a strategy directed at GxP compliance.
Traceability:
Traceability refers to the ease with which it is possible to inspect a drug’s development and any mistakes made during that process. A project that has followed GxP should trace any problems back to the exact moment they occurred so that the right people can be kept responsible and adjustments can be made to minimize future danger.
Accountability:
Pharmaceutical companies need to maintain a reliable, auditable record of who was involved in the manufacture and delivery of a drug, their task, and what their contributions to the project were to achieve transparency.
Why is GxP important?
Any company manufacturing life sciences products is affected because the GxP compliance for pharmaceutical regulations is global. It is, therefore, extremely essential to meet the GxP specifications. Although there are several GxPs, few of them are extremely important for any product’s life cycle.
What’s the purpose of GxP?
GxP exists, first and foremost, to protect customers like you and me. The guidelines are developed and enforced by national or international regulatory agencies, such as the Food and Drug Administration of the United States (FDA) or the International Council for Harmonization of Technical Requirements for Human Use of Pharmaceuticals (ICH), to ensure that products, research, and projects are carried out safely. That final products are safe to use.
The guidelines themselves are the minimum criteria that a company needs to meet to ensure that its products or services are consistently high in quality. The policies usually cover products or initiatives that could place the protection of people at risk.
That is why compliance with GxP is essential for organizations in the food, pharmaceutical, medical devices, life sciences, and other businesses operating within regulated industries.
What is GxP compliance?
GxP is a set of quality standards and regulations created during production, control, storage, and distribution to ensure that bio/pharmaceutical products are safe, meet their intended use, and conform to quality processes.
What is GxP Documentation?
Not only is the documentation of GxP somewhat close to GxP documents, but it also requires it. GxP documentation only means any pieces of registered data related to GxP compliance implementation, documenting, and communication.
Stated, it would not necessarily identify all GxP documentation as a GxP record, but all GxP documents are also GxP documentation.
What is Non-GxP?
With the awareness that regulators need GxP, it may be frustrating to encounter the word non-GxP. However, maverick pharmaceutical firms operating outside the law are not referred to as non-GxP.
Instead, it applies to early discovery research that is primarily academic and does not entail a collection of regulations as rigorous. Most research institutions and businesses claim will stifle their teams’ research speed.
Concept of GxP in Pharmaceuticals
The safety of its products is one of the main issues that the pharmaceutical industry continually tries to solve. GxP is a collection of regulations aimed at systematically and wholesomely addressing this matter.
The United States Food and Drug Administration developed the principle of GxP specifications in Pharmaceuticals. In many different areas, the word itself surrounds many various regulations.
The 5 Ps of GxP
For the pharmaceutical industry, there are various variants of GxP, each targeting a different stage of the pipeline for drug development, manufacture, and distribution.
People:
- Follow all procedures
- They are professionally educated and tested for the job they do.
- Have strong responsibilities
Procedures:
- Cover all important processes
- Ensuring that deviations are thoroughly reviewed and reported
- Documented and recorded
Products:
- Follow production and packaging techniques, tests, sampling, status control, stability testing, and records.
- Have raw materials, parts, intermediate and finished product specifications
Premises & equipment:
- Procedures, schedules, and records are validated and calibrated.
- They intend to enable effective cleaning and avoid cross-contamination.
Processes:
- Have identified critical steps
- Have robust methods of change control
- Clearly defined, consistent, and recorded
List of GxP in Pharma
Though there are many gaps, few of them are incredibly critical for any product’s life cycle:
Acceptable Manufacturing Practices (GMP):
GMP is the guidelines recommended by the approval and control agencies to manufacture products such as medications, medical equipment, active pharmaceutical ingredients (APIs), etc.
Ensuring that the agencies comply with requirements on the quality of the goods and that the suppliers take every step to ensure the product’s protection.
The guidelines extend to all aspects of production, requiring, for instance:
- Properly calibrated and maintained equipment
- The equipment is of the right size and in good shape.
- Using the right materials, containers, and labels
- Employees educate and train accordingly.
What is GMP and cGMP?
- Good Manufacturing Practices (GMPs) and Current Good Manufacturing Practices (cGMPs) are quality standards and guidelines that need to be adhered to by companies involved in food, cosmetics, medical devices, and pharmaceutical development.
- These regulations intend to ensure that suppliers are regularly producing high-quality goods that are safe to use or consume by individuals. Generally speaking, rules on development, testing, and quality assurance are established by GMP regulations.
Good Laboratory Practices (GLP)
These are the FDA guidelines for non-clinical laboratory testing and experiments to determine its safety and effectiveness.
GLPs are a set of standards that describe the context for a non-clinical study and clarify how to conduct, analyze, report, etc.
The Guidelines cover the safety testing of the products found in the following information:
- Feed additives and additives to feed
- Medicines
- Pesticides
- Cosmetics
- Industrial chemicals
Good Clinical Practices (GCP)
GCP is an international quality standard established by the International Harmonization Conference (ICH) that sets out the regulations for clinical trials of products involving testing on human subjects.
The criteria of a clinical trial and the officials’ duties and obligations involved in it specify the standards. It means that no human experiments are carried out only for the sake of medical development.
The guidelines specify the following:
- The trial must be based on sound scientific knowledge, and the appropriate oversight board or ethics committee must have approved its protocol before the trial proceeds.
- A licensed medical professional must provide any medical care subjects receive.
- All data should be registered, processed, and stored in a way that makes it possible to report, analyze and check it accurately.
Conclusion:
GxP should use a series of boxes to verify requirements to conform with legislation regarding analysis, production, and delivery of drugs and other medical items. Although the FDA or other government agencies identify and implement most of those elements of GxP, the purpose for their appearance is mostly to optimize and facilitate the drug development and development process for pharmaceuticals as it would be to secure their clients.
