The pharmaceutical industry is a heavily regulated industry. Here are lots of certification concepts applicable to the quality of products. GMP and GLP are two popular existing certifications that stand for Good Manufacturing Practice and Good Laboratory Practice respectively. Similarly, GxP stands for Good x (variable) Practices. It reflects that the company does all practices under proper regulations like GMP, GLP, and GDP. It ensures the products manufactured by GxP certified companies are of high quality and fit for use. The concept of GxP is a package of standards for the quality of products.
GxP is similar to other quality standards. It has the main five “P” practices that are listed below:
GxP
Concept of GxP:
People:
People working in GxP-approved companies should have a clear role and responsibility.
People have to follow all procedures and SOPs.
People should have the proper training for their delegated roles.
Procedure:
Every procedure should be documented and recorded.
In the procedure, all critical processes should be covered.
In the procedure, it should be ensured that every deviation is fully investigated and reported.
Products:
Every product should have specifications of raw materials, excipients, intermediates, and finished products.
Follow the master formula for manufacturing packing, testing, sampling, status control, stability testing and records.
Premises and Instruments:
Premises and equipment should be designed to allow effective cleaning and prevention of cross-contamination.
Equipment and machinery should be validated and calibrated, have procedures (SOP) schedules, and records are clearly defined, consistent, and documented.
Process:
All processes should have critical steps identified.
Should have a robust change control procedure.
How to align the concept of GxP?
All quality standards and accreditations are interconnected with each other. You can align GxP with other quality standards.
Neither quality standards cross the guidelines of other quality standards. The implementations of quality standards are arranged in a such manner so that they only enhance the impact of each other on the quality of products.
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What is GMP?
GMP is a system that provides assurance to the fact that all the products are manufactured according to quality standards.
Why is GMP important?
All low-impact medicines are not only a matter of financial loss for the government but also for the patient.
Compliance with the GMP standard is essential for manufacturing companies to meet the requirement of high-quality product output.
How does GMP promote the export of medicines?
Many countries in the World allow the import of only medicines that are manufactured in a GMP-certified company. Therefore, in order to increase drug exports, the local governments force their companies to get GMP certified.
GLP:
GLP is a quality system that ensures that the formulation and development of products have the ability of uniformity, consistency, reliability, reproducibility, quality, and integrity in all types of pharmaceutical testing. In the pharma company, the concept of GLP was first implemented in New Zealand and Denmark in 1972, and then it was brought to the US in 1978.
In all types of non-clinical studies, GLP is followed in pharma product quality standards. GLP practice provides a lot of useful data that is helpful in product development and removing existing errors. It is not only limited to pharma but it also has its role in medical devices, food, food packaging, color additives industry, etc.
In the United States, the US FDA’s 21CFR58 contains a special rule for GLP. This rule is applied for clinical trials on animals before clinical trials on human in America
European Union adopted 2 basic directives of GLP and rules made under them. It was first introduced in 1987 by the Europian Council. Directive 2004/10/EC moved to Directive 7/2016/EEC which took place on 11 March 2004.
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GDP:
GDP: Good distribution practice is a warehousing system in pharma warehouses and distribution.
The distribution of pharmaceutical products should follow the guidelines of GDP. There are lots of regulatory liabilities in the pharmaceutical distribution system.
The pharmaceuticals products are supplied to wholesale or retail drug license holders.
A proper record of distributors and retailer customers is maintained by the manufacturing company so that any disregard of drug law can be avoided.
Some viral concepts of GxP term GDP as “Good Documentation Practice”.
GCP:
GCP is a quality standard that is related to human clinical trials of medicines. The role of GCP in this field is to ensure that the benefits of the trial are more than the risk taken for the health of humans under clinical trials.
GCP controls the unnecessary and unauthentic trials by different pharmaceutical companies.
It also ensures the consent of the person over the trial is proposed to be done.
The person should be aware of the potential of risk with his health in the possible adverse effects of the trial.
Conclusion:
The sole purpose of GxP is to provide the assurance of the quality of the product that it is fit for human consumption.
The product is safe and free from undeclared adverse effects.
GxP is equally important in the pharmaceutical, Food, Medical devices industry, and cosmetics.
The core objective of GxP is good documentation practice, which is similar in intent to ALCOA+ in the pharma Industry.
GxP is a remarkable quality concept for the subject industries. The pharmaceutical industry observed a very positive impact on the quality of products after the concept of GxP implementation.
Reference:-
- WHO-Medicines-Good Manufacturing Practice
- GXP -From Wikipedia, the free encyclopedia
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