Why Regulated Industries Need GXP
July 7, 2021 (Investorideas.com Newswire) GxP is an acronym that refers to "good practices" in manufacturing, distribution, and other stages of regulated industries, such as pharmaceutical, laboratory, manufacturing, distribution, etc.
In each case, the "x" is replaced by the noun signifying the practices of that industry.
- GMP - Good Manufacturing Practices
- GCP - Good Clinical Practices
- GDP - Good Distribution Practices
- GLP - Good Laboratory Practices
- So on
These general terms refer to regulatory and customary practices that need to be undertaken to ensure quality and safety at every level of the processes in the industry or firm.
Although the regulatory laws vary by country, they are all similar. In the US, the requirements are outlined in CFR Title 21. In the EU, these same procedures are governed by Commission Directive 2003/94/EC. In all cases, the GxP that are defined by law vary by industry. Even though the GMP for the pharmaceutical industry might appear to be similar to those of the food processing industry, the laws are changed to recognize differences.
GxP are vital for all industries whose practices can affect the health and well-being of the public. Pharmaceuticals and food are obvious examples, but many industries have similar requirements. Moreover, even industries that aren't strictly regulated by the FDA (Food and Drug Administration) or national counterparts have created GxP to be followed to help them maintain high quality.
In this blog, we'll look at GxP in general and why they are vital for any industry whose practices might affect the health of the public.
5 Reasons GxP Is Important
1. It's needed for compliance
In regulated industries, such as food or pharmaceutical manufacturing, GxP are legally required. Often, the FDA lists them as as cGMP, current Good Manufacturing Practices. The FDA, as well as individual industries, recognize that manufacturing practices change faster than the laws governing them. By using the term "current, '' the regulatory agencies are able to set an expectation that an industry will improve its practices even if the laws are outdated.
As part of all compliance, proper documentation is required. Every step of the process must be documented and that documentation must be maintained over time to ensure that practices are being used constantly and consistently.
Dickson's GxP guide has more on the relationship between GxP and compliance.
2. It protects product quality
Proper manufacturing, distribution, and other practices help guarantee that product quality is maintained. If, for example, a manufacturer that produces aspirin allows standards relating to manufacture to drop, the aspirin might be ineffective, contaminated, or the wrong dosage.
Using Good Manufacturing Practices, manufacturers in regulated industries continue to produce products that are of as high a quality as the very first item they produced.
Product quality is more than a legal requirement, it's a consumer expectation. A food manufacturer wants its customers to keep returning because the consumer knows that the product will be the same high quality that it was the first time. Variable quality is one of the fastest ways for a consumer product to fall out of favor.
3. It maintains data integrity
In the 21st century, data is the most valuable asset a company has. Using Good Data Practices, companies can maintain data quality, prevent breaches, and avoid false or corrupt data from becoming part of the data stream.
This is often achieved by data storage companies including GDP in their policies and procedures. Companies like Amazon AWS and Microsoft have stated policies and define their practices to help their clients maintain data integrity.
Data integrity is as important now as it once was to lock filing cabinets and make copies of important documents for strategic personnel. Every regulated firm must ensure that data integrity is part of their GxP.
4. It is important for organizational accountability
Part of GxP is accountability, the ability to show what each person or division of a company contributed to a particular product. Because GxP requires detailed documentation of every step in the process, it's easy for regulators or management to see what individuals or groups have contributed to a product.
With accountability is traceability. Knowing each step in the process, one can trace backward to find places where problems exist, issues arose, or GxP fell apart. This allows leadership and regulators to correct processes.
5. It provides consumer peace of mind
Many firms list their GxP right on their websites, just as Amazon and Microsoft have done. This provides consumers and clients with what steps they're taking to protect everyone. Regulated organizations can use their procedures as part of their own GxP documentation.
For example, a laboratory using Amazon AWS for data storage can rely on Amazon's own GxP documentation to prove that data integrity is being maintained.
For the consumer, knowing the products they're purchasing were manufactured to the highest industry standards provides peace of mind that they're really buying something of good quality. Industries like auto manufacturing and electronics are obvious examples where failure to follow GxP might lead to recalls and even deaths.
GxP is Vital for Regulated Industries
GxP should be built into the procedural structures of any regulated industry, not simply because it's legally required, but because GxP protects consumers from poor products that can be worthless, dangerous, or even deadly. GxP helps maintain safety, quality, and peace of mind for everyone.
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