GxP in Pharmaceuticals.

What is GxP?

GxP is the bio/pharmaceutical quality guidelines and regulations created to make sure that bio/pharmaceutical products are safe, meet their intended use, confirm to quality processes during manufacturing, control, storage, and distribution.

"GxP were established by USFDA."

USFDA is the pharmaceutical regulatory governing body who are responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.*

*Source: https://www.fda.gov/about-fda/what-we-do

GxP is acronym which elaborate as follow:

G = Stands for Good 

x = Stands for Variable of application like M is for Manufacturing, D is for distribution, E is for Engineering, L is for Laboratory, C is for Clinical, R is for Review, S is for storage etc. 

P = Stands for Practice

Guideline mostly focus on below criteria:

• Data Integrity: Making sure that the data is accurate (ALCOA)
• Accountability: Who has done activity and when the activity has performed and it's sole responsibility.
• Traceability: Easily identified and proper back track to make sure to resolve problems instantly.

Below are the Industries Impacted by GxP:

• Pharma,
• Food,
• Medical devices, and
• Cosmetics.

GxP contains varied sets of regulations, but GCP, GLP, and GMP are the most common:

GMP (GOOD MANUFACTURING PRACTICE)

GMP consolidates the practices required to comply with the guidelines recommended by agencies controlling authorisation and licensing for the manufacture and sale of food , drugs and active pharmaceutical products;

Such standards include minimum requirements that must be met by a pharmaceutical or food product manufacturer to ensure that the goods are of high quality and do not pose a danger to the consumer or patients.

GCP (GOOD CLINICAL PRACTICE)

GCP is an international quality standard established by the International Conference on Harmonization ( ICH), an international body that sets guidelines that can be transposed by governments into legislation for human clinical trials.

It controls human experimentation done in medical sciences for the sake of advancement and serves as a quality benchmark as well as a moderator to keep such experimentation in check.

GLP (GOOD LABORATORY PRACTICE)

These are the standards set by the FDA for non-clinical laboratory tests and studies performed to assess the product's safety and efficacy.

GLPs are a set of standards that specify the structure for a non-clinical study and state how it should be performed, measured, published, etc.

For a product to be sold on any market , a must comply with the GxP regulations.