Earning a “good reputation” in the pharmaceutical industry can be challenging, and it can be quickly lost if the quality of the products or services does not meet the customers’ expectations. Many industries and regulatory agencies have developed a set of guidelines called “Good Practice” in order to avoid leaving quality to chance, some of these Good Practice guidelines have even become law for some industries. There are many different types of “Good Practise” when it comes to the Pharma industry. The term GxP refers to the entire group, however In this article, we will focus in particular on Good Manufacturing Practices for human drug products, to explain the concept in more detail.
What Is GxP?
GxP is the general abbreviation for “good practice” quality standards and guidelines. The “x” represents the various areas it can be applied to. The term GxP is often used to refer to a collection of quality requirements.
Sometimes a “c” or “C” is added at the beginning of the abbreviation. The preceding “c” stands for “current.” For example, cGMP is an acronym for “Current Good Manufacturing Practices.” Therefore, cGXP would refer to the concept of “Current Good Practices”.
Why Is GxP Important?
The importance and purpose of the GxP quality guidelines is to ensure that a product is safe and meets its intended use.
The GMPs are useful guides for designing and managing facilities, developing processes and products, and providing safety and quality guarantees to consumers. These guidelines can also help your company have greater efficiency and produce less waste.
Types Of GxP
The concept of GxP was initially created for the life sciences and food industries, but nowadays, almost every manufacturing industry has a GxP guideline. Some of the most well known GxPs are:
- Good “Agricultural” Practice (GAP)
- Good “Manufacturing” Practice (GMP)
- Good “Distribution” Practice (GDP)
- Good “Clinical” Practice (GCP)
- Good “Clinical Laboratory” Practice (GCLP)
- Good “Laboratory” Practice (GLP)
- Good “Automated Manufacturing” Practice (GAMP)
- Good “Documentation” Practice (GDocP)
- Good “Engineering” Practice (GEP)
- Good “Scientific” Practice (GSP)
- Good “Pharmacovigilance” Practice (GVP)
5 P’s Of GxP Compliance
Since the purpose of Good Practices (GxP) is to ensure that products are consistently produced to the appropriate quality standards, therefore, we can say that product quality reliability is guaranteed when we apply the following five critical parameters of GxP compliance:
A company is nothing without the people who run its activities. This is an indispensable part of it. Individuals are the heart of any organization and must be trained according to the desired result of the company.
The environment must not adversely affect the quality of the product, and access to the manufacturing area should be restricted to authorized personnel. In addition, facilities and equipment should be designed to facilitate effective cleaning and prevent cross-contamination.
The processes must be clearly defined. This has proven over time to help ease the production flow. This aspect of production requires the identification of critical steps and planning for possible changes in control procedures.
Since the idea is to produce quality products, we need to have testing methods, specifications, and standards available for all the materials used in the product, to avoid using materials that could have a negative impact on the quality of the product.
PROCEDURES (OR PAPERWORK)
By procedures, we mean proper documentation and recording of everything that happens in the company, proper reporting of deviations when they occur, and any other vital processes related to the quality of the product. Again, this could be digital or physical.
What Is The Difference Between GxP and Non-GxP?
The main difference between GxP and non-GxP is that when something abides by GxP the responsible person takes great measures to assure the safety and quality of products, placing special attention on traceability and data integrity.
Non-GxP usually refers to something that isn’t GxP compliant or that isn’t required to be GxP compliant. For example, software that allows data input, but doesn’t restrict who has access to the data and who can modify it, is an example of non-GxP software as it doesn’t have functions to assure data integrity.
Who Is Impacted by GxP?
Regulated industries such as food, pharmaceutical, medical devices, and cosmetics are the most impacted by GxP.
GxP Guidelines For Safe, High-quality Products And Outcomes
We can recognize that the specific goal of GxP guidelines is to ensure that the products produced under these guidelines are suitable for use, high-quality, safe and effective for the end user. To achieve this, companies must comply with strict quality standards throughout the entire production process.
GxP guidelines and regulations are global; though they may slightly differ from country to country, some of the popular regulators include FDA in the US, EMA in Europe, TGA in Australia, and HS-SC in Canada. Understanding, implementing, and maintaining GxP is an effective way to provide safe products to customers and instill confidence in an organization.
The GxP System Validation Process
In order to comply with GxP regulations in the pharmaceutical industry, it is necessary to have well-defined processes, adequate equipment, facilities in the necessary conditions, and qualified personnel.
In addition, a quality system is required to guarantee that all actions are carried out in line with regulatory expectations. In this sense, what supports the actions is the real evidence that the actions carried out in the regulatory field are consistent within the GxP.
Taking into account the aforementioned, the concept of Data Integrity gains special importance in GxP. For data to be GxP compliant, it must be attributable, legible, contemporary, original, precise, complete, consistent, available, and durable (ALCOA +); that’s why as part of the GxPs, it’s required to validate our processes and systems.
The validation of GxP systems is a procedure that guarantees that an application or computer system complies with GxPs, thus guaranteeing the quality of its processes.
These activities are, in summary, the following:
Design Qualification (DQ)
Report that guarantees that the design proposed by the supplier of the application complies with the regulatory requirements, the technical requirements, the operational requirements, and the purpose for which it is conceived (intended use).
Risk Analysis (RA)
Evaluation of potential risks that directly or indirectly affect product quality, patient safety, and data integrity. From this analysis, the scope of subsequent validation activities is obtained.
The question we must ask ourselves here is: Will it work? And what do we need to do to make it work for us?
Installation Qualification (IQ)
This is the technical verification that the installation has been carried out according to the qualified design.
The question we must ask ourselves here is: Was it installed correctly?
Operational Qualification (OQ)
Verifies that systems and equipment, as installed or modified, function as intended under all anticipated operating circumstances and comply with applicable regulations for the process and system.
The question we must ask ourselves here is: Does it work as it said it would work?
Performance Qualification (PQ)
The documentary verification is carried out after the OQ and measures whether the system works in an acceptable way under normal operating conditions.
The question we must ask ourselves here is: Does it work as we intended it would?
GxP Software Solutions
Nowadays, most sectors use computerized systems to operate and record their process from manufacturing, product testing, distribution, storage, logistics, etc. We refer to those types of software systems as either GxP Software Systems or GxP computerized systems.
Some of the most common GxP computerized systems are:
- Laboratory Information Management System (LIMS)
- Clinical Trial Monitoring Systems
- PLC for Controlled Packaging Equipment
- Supervisory Control and Data Acquisition (SCADA)
- Distributed Control System (DCS)
- Chromatography Data System (CDS)
- Enterprise Resource Planning (ERP) Systems
- Manufacturing Execution System (MES)
- Building Management Systems (BMS)
Which Sectors And Companies Need To Adhere To GxP?
In most cases, only companies that belong to industries such as food, pharma, biologicals, medical devices, and cosmetics are the ones who are required to be GxP certified. In some cases, companies that might look as if they do not belong to the before mentioned industries must also adhere to GxP if they provide services to these industries, e.g., 3PL companies.
GxP is the general abbreviation for “good practice” quality standards and guidelines.
GxP stands for “good practice” standards, and the “x” represents the various fields it can be applied to. For example GMP = Good “Manufacturing” Practice.
In the pharma industry, GxP standards help identify different regulations applicable to the various processes of research, manufacture, marketing, and distribution of medicines.
Compliance with GxP regulations requires having: adequate equipment, facilities, and personnel, validated, well-defined processes, and a quality system that guarantees that all actions are carried out in accordance with regulatory expectations to produce safe and effective products.
The main difference between GxP and non-GxP systems is that with GxP systems, we assure that our data is attributable, legible, contemporary, original, precise, complete, consistent, available, and durable (ALCOA +) to guarantee the quality and safety of our products.
GxP compliance means that we have a company that is able to produce high-quality products in a precise and reproducible manner within a controlled environment, avoiding contamination and with minimal quality risks.
The two main regulatory pillars for GxP are WHO (World Health Organization), since most of the countries worldwide use the WHO GxP guidelines, and the FDA in the USA.