While we aim to provide accurate and current information, this article should not replace staying up-to-date on updates and guidelines directly from regulatory bodies. If you need specific GxP temperature compliance advice, you can book a free consultancy with one of our specialists here.

Although the GxP guidelines are just that, guidelines, many regulatory bodies have incorporated the principles into their regulations. As such, following relevant GxP guidelines can serve as a step-by-step roadmap for achieving compliance.

In short: The type of products you work with determines which of the GxP – if any – applies to your operations. With these products, come different regulatory requirements and expectations from customers, both of which, form the basis for if, and which, GxP guidelines are relevant to your operations.

In the following section, we go through the different guidelines relevant to pharma and other life science industries, including under which circumstances they are applicable.

The meaning of GxP compliance in the pharmaceutical industry and for logistics storage of pharma products encompasses a broad range of "Good Practice" guidelines.

Also read: The key regulations of temperature compliance

Depending on the specifics of your organization, the key pharmaceutical GxP guidelines are:

• GMP (Good Manufacturing Practice): For the manufacturing, testing, and quality assurance of drugs to ensure that they are safe for human consumption. GMP is relevant if your operations involve the production of pharmaceuticals.
• GLP (Good Laboratory Practice): For the planning, performance, monitoring, recording, archiving, and reporting of laboratory studies, ensuring the quality and integrity of non-clinical safety studies. The guidelines apply to organizations conducting non-clinical environmental studies and laboratory research.
• GLDP (Good Laboratory Data Practice): Relevant for organizations handling data within pharmaceutical laboratories, ensuring the accuracy, reliability, and integrity of the generated data.
• GDP (Good Distribution Practice): For the proper distribution of medicinal products for human use to ensure their quality throughout the supply chain. GDP is relevant for companies involved in the distribution chain of pharma products.
• GSP (Good Storage Practice): Guidelines for the proper storage of drugs to maintain their quality, safety, and efficacy until they reach the end user.
• GCP (Good Clinical Practice): For designing, conducting, recording, and reporting trials that involve the participation of human subjects, and are, as such, relevant for entities conducting these clinical trials. GCP guidelines provide a framework of principles that protect the rights, safety, and well-being of trial subjects and ensure the integrity of clinical trial data.
• GVP (Good Pharmacovigilance Practice): For monitoring the safety of approved pharmaceutical products and identifying any changes to their risk-benefit balance, ensuring the protection of patients and public health.
• GRP (Good Regulatory Practice): To ensure that regulatory affairs within the pharma industry are conducted efficiently and meet all compliance requirements.
• GDocP (Good Documentation Practice): For creating, maintaining, and retaining documentation to ensure reliability and integrity in support of GxP activities. These guidelines are essential across all sectors.
• GAMP (Good Automated Manufacturing Practice): For the validation of automated systems in pharmaceutical manufacturing to ensure compliance with regulatory standards. GAMP is relevant if your operations leverage automated systems in the manufacturing process.
• GTP (Good Translational Practice): Guiding the translation of scientific research into clinical practice, ensuring that the translation process is efficient, ethical, and effective.

These GxP guidelines are vital in both biotech, pharma, and logistics as they help to ensure that every aspect of drug development, manufacturing, and distribution is conducted under strict quality control measures, safeguarding public health.

Tip! Eupry’s automated temperature compliance solution is built to simplify and secure GxP compliance for pharma.

GxP regulations encompass a broad range of compliance guidelines, and, of course, principles and requirements vary from guideline to guideline. However, the fundamental requirements of GxP include:

1. Quality management: Establishing a comprehensive quality management system that includes procedures, processes, and policies.
2. Personnel qualifications: Ensuring all personnel are adequately trained and qualified for their roles.
3. Facility and equipment: Maintaining facilities and equipment to prevent contamination, mix-ups, and errors.
4. Documentation and records: Keeping detailed and accurate records of all activities, changes, and validations to ensure traceability.
5. Production and process controls: Implementing controls throughout the production process to maintain product quality and consistency.
6. Quality control: Conducting rigorous testing and quality checks to ensure products meet specified standards before release.

1. Validation and mapping

Validation of your temperature-controlled environments (like fridges, freezers, or warehouses) is a vital process under GxP regulations. This process, including temperature mapping studies, ensures that the storage environments can maintain the required conditions for the specific products.

Also read: Guidelines for effective and reliable temperature mapping

2. Calibration

As validation of the storage unit, calibration of temperature data loggers is a significant part of GxP guidelines for pharma. This process ensures that the equipment used for temperature monitoring provides accurate measurements.

Also watch: Overcoming data logger calibration challenges in GxP environments

3. Monitoring

Ongoing temperature monitoring is essential for validating that the temperature conditions remain within the required limits over time.

Also read: How to master temperature monitoring in critical environments

4. Deviation management

The ability to detect, document, and address deviations from the expected temperature ranges is crucial for maintaining GxP compliance.

5. Data management:

The management of data, including recording, storing, and reviewing temperature data, is integral to demonstrating compliance with GxP.

Psst… See how Eupry’s automated temperature compliance solution takes these five areas into account.

*Temperature compliance is an umbrella term covering quality efforts to ensure that products are developed and stored within specified temperature ranges crucial for maintaining their efficacy and safety.

From validation and ensuring dependable monitoring to managing calibration, deviations, data integrity and much more – how do you efficiently ensure that your temperature compliance efforts adhere to GxP?

Entering the use of GxP-ready monitoring systems.

Even though digital systems can never stand alone in securing your compliance, a reliable temperature compliance system tailored to GxP requirements can take you a long step of the way.

GxP standards help organizations manage and maintain quality by outlining specific guidelines for various practices, including manufacturing, laboratory testing, storage, and distribution. Collectively, the guidelines outline methods by which organizations in regulated sectors can manage their ways of working to guarantee the uniformity and quality of their products.

By using automated solutions, you can make adherence to regulatory standards simpler, streamline your compliance processes, and focus on your core mission.

Oh, and Eupry’s temperature compliance solution is built to meet the requirements of GxP in pharma, biotech, and pharmaceutical logistics.

Now would you look at that?