Thermal validation is an essential process in many industries, including pharmaceuticals, biotechnology, and food production, to ensure that temperature-sensitive products are stored, transported, or manufactured under optimal conditions. The goal is to guarantee that products maintain their integrity, efficacy, and safety. Compliance with industry standards is crucial to achieving reliable thermal validation results and meeting regulatory requirements. In this blog, we will explore eight industry standards that you must be aware of for successful thermal validation.
1. FDA 21 CFR Part 11
The FDA’s 21 CFR Part 11 is a crucial regulation for industries that handle data related to drug production, storage, and distribution. This regulation sets the standards for electronic records and electronic signatures, which are often used during thermal validation.
Why It Matters: 21 CFR Part 11 ensures the integrity of data collected during thermal validation and requires that all electronic records related to temperature control are reliable, accurate, and secure. This includes the temperature monitoring and recording systems used during validation.
Example: For a pharmaceutical company validating the temperature conditions in a storage facility, the temperature data must be recorded electronically, and the system must be capable of generating secure reports and maintaining an audit trail in accordance with 21 CFR Part 11.
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2. ISO 9001:2015
ISO 9001:2015 is a global standard for quality management systems (QMS). It helps organizations ensure that their processes, including thermal validation, are effective and continuously improved.
Why It Matters: The ISO 9001:2015 standard provides guidelines for managing the quality of processes, including monitoring and controlling critical parameters such as temperature. Adhering to this standard ensures that thermal validation processes are repeatable and consistent.
Example: A food production facility seeking to validate its refrigerated storage conditions would need to follow ISO 9001:2015 guidelines to ensure the process meets the organization’s quality management objectives and includes proper documentation and process control.
3. ISO 17025:2017
ISO 17025:2017 is the international standard for testing and calibration laboratories. It defines the requirements for laboratories to ensure the accuracy, reliability, and credibility of their results, including temperature measurements.
Why It Matters: For thermal validation, ISO 17025:2017 provides the foundation for ensuring that temperature-measuring equipment and systems are calibrated correctly and produce accurate data. Laboratories performing thermal validation need to comply with this standard to ensure that results are credible and compliant.
Example: A company conducting thermal validation of its pharmaceutical packaging system must ensure that their laboratory is accredited to ISO 17025 standards, ensuring that temperature measurement equipment is calibrated and verified for accuracy from an approved NABL accredited calibration lab..
4. Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) are regulatory guidelines that ensure products are consistently produced and controlled according to quality standards. Thermal validation is an integral part of GMP in industries like pharmaceuticals and medical devices.
Why It Matters: GMP guidelines require that temperature-controlled environments, such as warehouses or cleanrooms, are continuously monitored and validated to ensure that temperature-sensitive products are stored and handled properly throughout their lifecycle.
Example: A pharmaceutical manufacturer must validate the temperature conditions during the storage and transportation of vaccines in accordance with GMP standards to ensure product quality and regulatory compliance.
5. ICH Q10: Pharmaceutical Quality System
The International Council for Harmonisation (ICH) Q10 guidelines focus on maintaining a pharmaceutical quality system (PQS) throughout the lifecycle of a product. These guidelines emphasize the importance of risk management and process control, including thermal validation.
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Why It Matters: ICH Q10 highlights the need for controlling temperature as part of the overall pharmaceutical quality system. Thermal validation is essential to ensure that temperature-sensitive products remain within specified limits during storage and transportation.
Example: A pharmaceutical company developing temperature-sensitive biologics will incorporate ICH Q10 guidelines into their thermal validation process, ensuring the entire product lifecycle is controlled and that temperature deviations are appropriately managed.
6. EU Good Distribution Practice (GDP)
EUGMP stands for European Union Good Manufacturing Practice. It refers to the guidelines and regulations set by the EU to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. It’s all about ensuring that products are safe, effective, and of high quality.
Why It Matters: EUGMP (European Union Good Manufacturing Practice) is essential because it ensures medicines are made safely, consistently, and to high-quality standards. It helps companies meet legal requirements, builds trust with consumers and healthcare professionals, minimizes risks like contamination and errors, and facilitates global trade. Ultimately, EUGMP guarantees that medicines are safe, effective, and reliable for public health.
Example: A company involved in the distribution of temperature-sensitive vaccines in the EU must conduct thermal validation of their transport vehicles and storage facilities to comply with EUGMP guidelines and ensure product integrity.
7. US Pharmacopeia (USP) Chapter <1079>
USP Chapter <1079> provides guidelines for the monitoring, control, and validation of temperature conditions in pharmaceutical environments. This standard is critical for ensuring that temperature-sensitive products, such as sterile drugs and biologics, are handled appropriately.
Why It Matters: USP Chapter <1079> outlines the specific temperature monitoring and validation requirements for pharmaceutical manufacturing and storage. It covers a wide range of practices, including the design of temperature-controlled environments and the need for periodic re-validation.
Example: A pharmaceutical company needs to validate the temperature range for their warehouse storage system for injectable medications. By following USP Chapter <1079>, they can ensure that their process is in line with regulatory expectations for temperature monitoring.
8. FDA 21 CFR Part 820
FDA 21 CFR Part 820 outlines the quality system regulations for medical devices.These regulations outline the requirements for the design, manufacturing, packaging, labeling, and servicing of medical devices to ensure they meet safety and quality standards.
Why It Matters: For medical device manufacturers, temperature control is critical to ensuring product integrity. Validation under FDA 21 CFR Part 820 ensures that medical devices are manufactured and stored under proper conditions and meet safety and effectiveness requirements.
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Example: A manufacturer of temperature-sensitive medical devices, such as syringes or diagnostic kits, must validate the temperature conditions in the storage and shipping areas to comply with FDA 21 CFR Part 820, ensuring the devices remain safe and effective for use.
Conclusion
Thermal validation is an essential part of ensuring the quality, safety, and efficacy of temperature-sensitive products across various industries. Adhering to these key industry standards, including FDA 21 CFR Part 11, ISO 9001:2015, GMP, and others, ensures that your thermal validation process meets regulatory requirements and maintains high-quality practices.
Partnering with Incepbio provides you with expert guidance in navigating these standards, conducting thorough thermal validation, and ensuring compliance throughout the product lifecycle. With our expertise, we help you achieve reliable, repeatable results while maintaining the highest industry standards for thermal validation.
For more information or to discuss your thermal validation needs, contact Incepbio today!
