Here are some of the most common GxP categories:
GCP: Good Clinical Practices
GCP regulations govern clinical trials involving human subjects. GCP regulations ensure the safety and ethical treatment of participants, the validity of the data collected, and the integrity of the entire research process.
GLP: Good Laboratory Practices
GLP focuses on non-clinical studies, ensuring the reliability and integrity of data collected in labs. This applies to testing the safety and effectiveness of products on animals or in controlled environments before human trials.
GMP: Good Manufacturing Practices
GMP is concerned with the manufacturing process itself. GMP regulations ensure that medications, medical devices, and other products are produced consistently and meet strict quality standards to minimize contamination and maintain effectiveness.
Whatever set of regulations it is, GxP ensures safe and effective healthcare products that consumers can trust.
What is GxP Storage?
Just like it sounds, GxP storage refers to specialized storage that complies with the various GxP regulations. These regulations ensure the safe and proper storage of all study data along with products like medicine, medical devices, and samples used and produced in research.
Regulatory bodies like the FDA (US) or MHRA (UK) require GCP, GLP and GMP studies and processes to be archived to support their validation and use in future research. GxP storage takes care of the archiving requirements set forth by the regulatory bodies.
Here are some examples of data that is required to be stored whether it’s paper, electronic, or regulated material:
- GCP: Storing clinical trial data, protocols, consent documentation, samples, and any other relevant information from the GCP study.
- GLP: Storing non-clinical trial data, protocols, consent documentation, samples, and any other relevant information from the GLP study.
- GMP: Storing records of product development including raw material information, tests, material use, labeling, packaging, and more.
Requirements for GxP Storage
There are strict requirements for GxP storage and archiving. Here are some of the basics at a high level:
- Temperature control: Regulated material needs to be stored at specific temperatures to maintain their efficacy.
- Environmental monitoring: Temperature, humidity, and other environmental factors need to be monitored and documented to ensure consistent storage conditions.
- Security: Storage facilities need to be secure to prevent unauthorized access, theft, or even losses due to natural disasters.
- Record keeping: Accurate records need to be maintained of all storage activities, including temperature logs, access logs, and the chain of custody.
Summary
Companies and researchers that deal with regulated material can build their own GxP compliant storage facilities or use a storage provider that specializes in GxP compliance, like GXP-Storage. Just like our name suggests, GXP-Storage covers the full range of regulated research and manufacturing materials and ensures compliance with the complex regulatory requirements.