Safety of their products is one of the most significant concerns that almost every individual business in the pharmaceutical industry can relate to. Better known as ‘GxP’ (Good Practice), these regulations are the quality standards set for a specific activity or field.
Today, GxP compliance is one of the significant aspects of the pharma industry, and businesses of every shape and size need to align to it. This piece is your ultimate guide to help you understand the term and how you can comply with it.
What is GxP, and How can Your Organization Comply to It?
In simple terms, GxP is a set of guidelines that ensure the industry’s safety and services. Established by the U.S Food and Drug Administration (FDA), these compliance guidelines revolve around two significant regulatory pillars: traceability and accountability.
Further, the ‘x’ in the full-form stands for a particular field, depending on the type of field, whether its distribution (GDP), manufacturing (GMP), or laboratory (GLP), among others. The GxP guidelines generally similar across multiple countries, with each country having its regulator.
How can your Organization be GxP Compliant?
The steps are easy; to cater to GxP compliance needs, your organization needs to keep a track record and log every action, document made by individual employees in the production or development of a project or product. Further, such organizations must also ensure that they are safe to meet their intended use and aligned to the stages of manufacturing, storage, control, and distribution of a project.
The 5 Ps of GxP
- People
- Follow all procedures.
- Have clear responsibilities and roles in their job.
- They are completely trained and assessed for the work they are assigned to do.
2. Procedures
- Every process is recorded and documented.
- To ensure proper cover across all the critical processes.
- Ensure that individual deviations are fully reported and investigated.
3. Products
- Have specifications for components, raw materials, the intermediate and finished product
- Follows every step involved in the methods of manufacture and packing, sampling, testing, stability testing, status control, and records.
4. Premises & Equipment
- They are engineered to allow effective cleaning and prevent cross-contamination.
- Are calibrated and validated, have schedules, procedures, and records.
5. Processes
- Everything is clearly defined, documented, and is consistent.
- Have robust change control procedures.
- Have all the significant steps identified.
Now that you know all the P’s involved in the pharma industry, it’s time to have a look at the most common regulations across the industry.
Good Clinical Practice (GCP)
GCP is the quality standards defined by ICH (International Conference on Harmonization), responsible for stating the regulations on the clinical trial of products that require testing human subjects.
Good Manufacturing Practice (GMP)
GMP are the basic guidelines that are recommended by agencies, allowing the control and authorization of manufacturing different pharmaceutical items such as medical devices, drugs, active pharmaceutical ingredients (APIs), etc.
Good Laboratory Practice (GLP)
As the name suggests, GLP enlists all the standards for non-clinical laboratory studies and tests, as recommended by the FDA. GLPs include a well-defined set of standards that lay down the framework for non-clinical studies.
Conclusion
GxP is the desired quality standards set by the authorized body for cosmetics, food, medical devices, and pharmaceutical manufacturing industries. These regulations ensure consistent quality in the manufacturing of different high-quality products. If your company fails to align with any of the suggested Good Practices, the chances are that your business might face severe actions by the regulatory firms.
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