Good practices can be defined as regulated guidelines. Consistent application of good practices is an essential part of manufacturing almost any product that will be in direct contact with a consumer. In this article, we will take a closer look at examples of good practices and the reasons why these practices are important in the different industries where they are required.
Many Different Kinds of Good Practices
Written as GxP, the ‘x’ of the acronym refers to the specific area to which the good practice is related. As an example, GLP indicates that a laboratory is involved. GDP is for distribution and GMP refers to manufacturing. Several more designations replace the “x’ in GxP. When a “c” is used, which reads cGDP, the “c” indicates that the most current version of the standard was used for reference.
In this guide to GxP, Dickson states that GxP includes a range of practices, guidelines, and standards regulated companies should abide by in order to maintain compliance.
The Three Pillars of Good Practices
GxP is used in many different industries such as the food processing industry, pharmaceutical industry, manufacture of medical devices, and safety regulations in the aviation industry. GxP follows three pillars: traceability, accountability, and data integrity. Let’s take a closer look at what each of these pillars is and how they interact with each other.
This is related to record keeping and the information included as part of a record. In other words, traceability is the proof that verifies each required step of a process that was followed to create the product or material. Some details that would be included as part of the traceability are equipment qualification, process validation, information on raw material batches, and the environmental conditions at the time of processing.
Traceability has more to do with machinery. Accountability, however, is more closely related to the people involved in a given manufacturing process. The data collected to create the accountability files could include the identities of all people who participated in a process, or the qualifications and training levels of each employee to ensure that all participants carried the same or all the required skills to accomplish the process goals. This might include detailing who was operating a given piece of machinery and their complete training logs for cross-reference.
This connects the other two pillars. Data integrity is defined by the Food and Drug Administration (FDA) as data that is complete, consistent, and accurate. Any data collected for GxP purposes should meet the ALCOA rule of attributable, legible, contemporaneously recorded, original or a true copy, and accurate. With these guidelines in place for data collection, traceability and accountability are ensured.
Examples of GxP In Different Industries
The GxP guidelines differ somewhat from one industry to the next where they are required. However, the main principles remain intact. Here is a look at a few regulated industries where GxP is applied and why these guidelines are required.
Safety and effectiveness are the main reasons GxP exists in the pharmaceutical industry. The guidelines follow the entire lifespan of any given pharmaceutical product and focus primarily on good clinical practice. Included in this example are testing, good laboratory and manufacturing practices, good storage, and distribution practices. This would be for such items as vaccines, blood, organs, and any other item that would eventually be used or inserted into a human.
The regulations that form guidelines to GxP with medical devices are very similar to those that apply within the pharmaceutical industry. Depending on the specific medical device, guidelines that govern good laboratory practices may apply. Examples where this would be the case include conditions when pre-clinical data related to the safety of the device is being collected. The FDA is tasked with regulating good clinical and manufacturing practices for medical devices in the United States, including those being imported to the US.
Food and Agriculture
GxP when applied to the food and agriculture industries is primarily put in place to prevent illnesses. The methods by which microorganisms spread include foodborne and cross-contamination of allergens. The FDA (Food and Drug Administration) is in charge of regulating the industry by using GxP guidelines. The FDA requires that anyone who comes in contact with food-from the manufacturing of it to the processing, packaging, and storage of it-be properly trained and qualified to do these tasks. In agriculture specifically, GxP relates to the handling of fruits and vegetables before reaching the market.
The aerospace industry has a completely different set of GxP that is designed specifically for this industry. These guidelines are in place to ensure aircraft safety and airworthiness. The guidelines assist OEMs, part suppliers, and distributors. They also outline the standards for maintenance.
How to Ensure GxP are Being Met
The easiest way for companies in regulated industries to remain compliant with the standards laid out in the GxP of their given industry is to do the following:
Validate Equipment and Procedures
As technology continues to evolve, it is a good idea to conduct a regular validation process. This would include a review of existing procedures with changes implemented to reflect new requirements and regulations. Equipment upgrades or replacement would also fall under these reviews and checks.
Conduct Internal Audits Regularly
To be ready for an actual audit, regular internal audits are highly recommended. These will reveal areas that need improvement or attention. With regulated guidelines in place, it is vitally important to be in compliance at all times with all regulated guidelines that are in place. Internal audits help prevent issues from getting out of hand or being overlooked and will save your company money in the long run.
GxP is regulated by the guidelines that are applied to many different industries. They are mostly related to products that will end up in contact with consumers. While each specific industry has unique requirements, the core principles of GxP are the same. By keeping your company compliant, you remain an important part of the process that supplies services or products to the rest of us.