Gxp Compliance Things You're Forgetting to Do

The use of good practices within the industry of the regulated sector, such as the pharmaceutical, and especially the application of the norm Current asset is known as GxP. The 'x' stands for the particular field, whether that's manufacturing (GMP), Documentation (GDP), laboratory (GLP), and so on.

The application of standards (GLP, GCP, GMP, GDP, GEP) to the entire supply chain, ensure that they have an acceptable level of quality and safety for the patient or consumer. These regulations are mandatory for the pharmaceutical, veterinary and cosmetic sectors.

 

What GxP means and its importance for the pharmaceutical industry

GxP is a general abbreviation to identify the different regulations applicable to the different processes of research, manufacture, marketing and distribution of medicines, where the "x" is a substitute element for the field to which it refers. We will see later.

One of the most important aspects of GxP compliance is data integrity and traceability throughout the value chain. In the integrity of data, it is sought that they are attributable, readable, contemporary, original, accurate, complete, consistent, available and durable (ALCOA +).

 

Another common point within the regulated sector is the traceability of the actions within each area and also between the different stages of the life cycle or stages of the product, from research to delivery to the point of sale or consumption.

Within the supply chain we find various stages such as GLP, GCP, GMP, GDP, GEP or GXP, Some of them are can be Described as:

Good laboratory Practices

GLP (Good Laboratory Practices) brings together a series of principles whose purpose is to guarantee the reliability and safety of basic research studies of new drugs, new pharmaceutical forms or new prescriptions.

Good laboratory practices are regulated in the European Community through the Organization for Economic Cooperation and Development (OECD GLP), establishing quality standards for the administration and management of research facilities and for conducting and reporting studies. related to the safety of investigational drugs.

 

The GLP principles guarantee that the studies presented to the regulatory authorities are of quality and consistency, ensuring:

 

Design of testing and storage area.

Equipment cleaning and calibration.

Carrying out the tests.

Recording and publication of results.

Good clinical practices

GCP (Good Clinical Practices) gather a series of guidelines that include the global regulations for the conduct of research that involves the use of human beings. The ICH E6 (R2), (ICH = International Conference on Harmonization), introduces thirteen ethical and research-quality principles of medicines in humans, to guarantee the safety and well-being of the participants in clinical trials. These thirteen principles are:

 

Respect the ethical principles of the Declaration of Helsinki.

A study can only be started if the potential benefits justify the risks.

The safety, rights and welfare of the subjects is the most important.

Adequate information is required before the study.

Studies must have scientific bases and defined protocols.

The study must be carried out according to the protocol approved by an ethical committee.

A researcher (qualified doctor) will take care of the subjects.

Individuals must have the appropriate characteristics for participation in the study.

All the information generated in the study must be documented and filed.

Managed products must follow GMP (Good Manufacturing Practice).

The study sponsor is responsible for establishing security systems in the study.

The informed consent of the participants is required.

The principles of privacy and confidentiality with participants must be followed.

The GCP guidelines place special emphasis on clinical trials involving drugs or medical devices.

 

Good manufacturing practices

The GMP (Good Manufacturing Practices) consist of a series of standards for the correct manufacture of products. The Correct Manufacturing Standards ensure that the products are manufactured under adequate control and supervision.

The European Community adopted two directives that establish the directives of the correct manufacturing standards, directive 2003/94 / CE (medicines and investigational medicines where humans participate) and directive 91/412 / CEE (medicines for veterinary use). These directives are mandatory for all manufacturers located in the European Union.

Within these guidelines we find indications for the pharmaceutical quality system that includes personnel, premises and equipment, registration and documentation, manufacturing, quality controls, activities subcontracted to third parties, claims, quality defects, product recalls, and mandatory self-inspection.

GDP Stands for Good Documentation Practices, GEP stands for Good Engineering Practices,

 

The importance of data in the GxP environment Compliance with GxP regulations requires, on the one hand, having:

adequate equipment, facilities and personnel,

well-defined processes,

and a quality system that guarantees that all actions are carried out in accordance with regulatory expectations (GxP).

At this point, the real evidence that the actions carried out are consistent with the GxP are the data that support the actions. Furthermore, audits and inspections are based on their review, whether it is data in paper format or electronic data (defined as electronic records ).

 

Here the concept of Data Integrity (ALCOA +) takes on its vital importance . The data must be reliable in obtaining it and, above all, it must always be available for consultation during the retention time required by the different regulations.