Industries that are regulated must follow good practices to meet and maintain specific regulatory and safety standards. Different industries have different guidelines that define the good practices in their particular industry. In this article, we will discuss what good practices are, who regulates them, and how they fit into the pharmaceutical industry.
What Is GxP and Why Is It Important?
Good Practices, or GxP, are guidelines that are applied to the processes that create a product. According to Dickson, they cover a wide range of guidelines companies must follow to stay on the right side of regulatory standards in multiple quality-sensitive industries.
In the pharmaceutical, medical device, and food industries, those good practices focus primarily on items that will come in direct contact with consumers as products used or ingested by them.
The “x” in the abbreviation GxP refers to a specific type of industry-wide good practice. If the guidelines that are in the good practices framework concern laboratories, the “x” becomes an “L” and the designation becomes GLP. If the GxP is for distribution practices for products, it becomes GDP. If the field is based on manufacturing, the GxP becomes GMP. In cases where the standard has been updated, the designation is cGxP, with “c” signifying “current” version.
What Rules and Organizations Govern GxP for Pharma?
The US Food and Drug Administration (FDA) is responsible for creating, enforcing, and in many cases monitoring the good practices in the industries that fall under its aegis of enforcement and regulation. These industries include the pharmaceutical industry. The GxP system rests on three primary pillars: Traceability, Accountability, and Data Integrity.
Traceability refers to the recording of all information that covers the processes used to create a product or material. It is much like a written journal that notes every step in the manufacture of a product, details each step, notes extra development processes or potential deviations from an established process, and traces the supply chain for every product’s ingredients until it has reached its final outcome.
Accountability is the creation and maintenance of all records and documents that verify and identify every person involved in any part of the process of creating a product, including their qualifications, levels of training, and any changes in certification. This is an important pillar of good practice.
Data Integrity connects Traceability and Accountability. It is where the “completeness, consistency, and accuracy of data” (according to the FDA) ties them all together. Data collection must follow the ALCOA protocol: Data must be Attributable, Legible, Contemporaneously recorded, Original, and Accurate.
What Are Some Key GxP Areas For The Pharma Industry?
For the safety of consumers, the US FDA has implemented many guidelines adhering to GxP principles that the pharmaceutical industry is mandated to follow. Pharmaceutical and medical device industries must follow stringent standards in their manufacturing processes, which must be regularly audited, as well as in their facilities, processes, and procedures that test their products.
The FDA has also conducted several inspections of facilities located overseas. It has focused on facilities from which medications and raw materials are exported into the United States.
As for the standards required in the pharmaceutical industry, the GxP guidelines are in CFR (Code of Federal Regulations) Title 21, Chapter 1 with key components noted in the following sections.
CFR Parts 210, 211
This standard is related to the manufacturing, storage, and distribution of pharmaceuticals.
CFR 21 Part 820
This standard is focused on medical devices.
CFR 21 Part 11
This standard details the requirements related to electronic record-keeping.
Tips On Maintaining Good Practices in The Pharmaceutical Industry
Below are six helpful tips that can assist in meeting and maintaining the standards required for good practices in pharma. Organizations that pay close attention to each will find themselves ahead of the game when it comes to maintaining good practices. Here is a quick look at each of them and how they pertain to compliance.
Tip 1 – Data Recording
Following the ALCOA protocol (outlined above) helps manufacturers ensure that they are recording, in detail, all the information required by the FDA in a format that can be easily understood.
Tip 2 – Data Storage
Ensure that the information your manufacturing facility or company is mandated to collect and document is stored in a facility designed for this purpose and in a manner enabling you or the FDA to locate specific information efficiently.
Tip 3 – Documentation
Use Standard Operating Procedures (SOPs) to properly document all processes and systems that are in place in your facilities; regularly review your SOPs to ensure that they are up-to-date and accurately reflect actual processes, procedures, and systems.
Tip 4 – Training
Audit and ensure that all employees working on-site and at all levels have the proper training and qualifications for their position and responsibilities. Provide additional training to encourage and support advancement.
Tip 5 – Monitor Compliance
Help avoid GxP violations flagged by the FDA by implementing a systematic approach to validate equipment and procedures and to correct problems as soon as they appear.
Tip 6 – Audit Internally
Conduct regular internal audits to prepare you, your employees, and your facilities for FDA inspections. Doing so may reveal situations that require immediate attention. By being prepared, you are ready for anything.
In Conclusion
Good Practices define the standards required in regulated industries to meet and maintain specific levels of quality control. The specific standards vary from industry to industry but primarily revolve around three main components. They include traceability, accountability, and data integrity. These in combination help companies create the framework necessary for compliance.
The GxP required for pharmaceuticals and medical devices differs from those required in the food industry, manufacturing, or aviation. The US FDA is responsible for the regulation of good practices in the raw materials, manufacturing processes, and testing of products for pharmaceuticals and medical devices. Following the guidelines set out in CFR Title 21, Chapter 1 helps to prevent procedural or manufacturing violations. It should be a comfort to know that such things as medications and medical devices are expected to meet certain standards. Thanks to GxP, they are constantly being monitored.
