GXP Concept in Pharmaceuticals

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Pharmaceutical industry has created many acronyms for it’s own convenience, GXP is one of the most popular that we all use. The term GXP is a collaboration of all the quality guidelines that aim for the product that is safe and meet it’s intended use.

GXP means - Good (Pharmaceutical) Practice
GXP means – Good (Pharmaceutical) Practice

Basically G stands for Good, X= is a variable that is specific practice descriptor and has its own purpose of statement, P stands for practice. For example if “X” is replaced “M” then it is Good Manufacturing Practice. Although there are many regulatory guidelines that are defined under the concept of GXP but mainly discussed are: GMP, GDP, GLP and GCP.

gxp

The concept of “GXP” was established by United States Food and Drug Administration, published in the code of federal regulations. The main purpose is to define a set of guidelines that ensures the product prepared through regulated procedures that are of high quality. The central aspects of GXP are 1) Traceability: The ability to reconstruct the developmental history of a drug or medical device. 2) Accountability: The ability to resolve who has contributed what to the development and when.

Sometimes “c” is added in front of GXP, this preceding “c” stands for current. For example: cGMP : Current Good Manufacturing Practice, cGCP: Current Good Clinical Practice.

A) GMP (Good Manufacturing Practice): The concept to develop regulatory guidelines for the manufacturing of drugs came through a series of incidents that occurred due to flaws in the manufactured product.

OUTLINE OF GMP:

1906 : Pure Food & Drug Act
  • Inspired through a book called “The Jungle” written by Upton Sinclair defining unsanitary conditions in which animals were slaughtered and processed.
  • It became illegal to kill contaminated food or meat.
  • No false information on labels tolerated.
1938: Federal Food, Drug & Cosmetic Act
  • Linked with the tragedy of usage of wrong raw material (diethyl glycol) in the elixir of sulphanilamide. It caused 107 deaths before the problem was figured out.
  • It became mandatory for manufacturers to provide safety of products before marketing.
1940’s and 1950’s In 1941

  •  Around 300 people affected by the sulfa drug (sulfathiazole tablets) tainted with the sedative phenobarbitol.
  • Make FDA to revise manufacturing & quality control requirements later called GMP’s.

 

In 1955

  • Manufacturers failed to inactivate the polio virus that resulted in development of polio in about 60 individuals.
1962: Kafauver- Harris Drug Amendments
  • Thalidomide tragedy caused birth defects in thousands of European babies.
  •  It became mandatory for manufacturers to prove efficacy of product before marketing.
  • Also to have a strict overlook at the drug testing.
1978: cGMP : Final rules for Drugs & Devices [ 21 CFR 210-211 and 820
  • Minimum standards for the manufacturing, processing, packaging or holding of drug products and medical devices were developed.

 

The main agenda of GMP was to incorporate quality in the systems and processes rather than testing the quality in the finished product. Major building blocks of GMP are controlling quality in testing materials (QC) and controlling processes (QA) along with well trained staff, documentation, good premises/ equipment to obtain high quality product.

B) GDP (Good Documentation Practices): 

It is said in pharmaceutical industry that ” if it isn’t documented, it didn’t happened”. The stanza itself defines the importance of Good Documentation Practices. Therefore, it is obligatory in pharmaceutical industry to document  incidents as a “proof” that something happened. Hence they are considered critical. They clearly defines the aspect of traceability through which clear, accurate, timely data if documented clarifies all the aspects related to a record. In common words they ” tell the story” of a manufactured products. It is enforced by many regulatory agencies because of it’s importance.

glp-regulatory-bodies

C) GLP (Good Laboratory Practice): 

The concept originated in the USA in 1970’s when non-clinical safety data was submitted to FDA in the context of New Drug Application. The compromised validity of the data led to the FDA’s publication of Proposed Regulations on GLP in 1976. These regulations were set up for USA companies or who wanted to work with USA companies. On international level organisation named OECD (Organisation for Economic Co-operation & Development) produced GLP principles in 1981. Through these principles the check on laboratory studies (non- clinical) is made in which how they are conducted, reported and archived. In pharmaceutical industry GLP focuses on following main points: Resources, characterization, risks, results and QA.

RESOURCES
  • Organisation
  • Personnel
  • Facilities
  • Equipments
CHARACTERISATION
  • Test Items
  • Test Systems
RULES
  • Protocols
  • Standard Operating Procedures (SOP)
RESULTS
  • Raw Data
  • Final Report
  • Archives
QUALITY ASSURANCE
  • Independent monitoring of research processes

 

D) GCP (Good Clinical Practices):

These are the set of the regulations that are build to conduct trials on human beings. The trials are conducted through proper channel in which preliminary data (non- clinical) if found satisfactory are promoted to next level. The trials are only conducted if the anticipated benefits justify the risk associated with the trial. It is clearly stated in Quality Guidelines Q6 (ICH) that the rights, safety and well being of the trial subjects are of utmost importance. The significance of the trials is not hidden as it directly links with the promotion of the medicine field as new medicinal product in the market is due to the successful clinical trials and data generated through the pharmacokinetic and pharmacodyanamic principles.

SUMMARY:

The term “GXP” is very vast as it underlines many more variables that are either related to pharmaceutical or any other field. They are not of utmost importance but they have their own significance. For example: Good Auditing Practice (GAP), Good Agricultural Practice (GAP), Good Business Practice (GBP), Good Distribution Practice (GDP), Good Engineering Practice (GEP), Good Pharmacovigilance Practice (GVP), Good Pharmacy Practice and many more.

 

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Jasleen Kaur a post graduate M. Pharm (Q.A.) is a senior pharma writer. She is responsible for authoring, reviewing and editing a range of pharmaceutical documents, including SOP, Validation, Qualification etc.

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