The past few years have shown that running any business has become increasingly difficult. Thanks to labor and product shortages, resources are consistently stretched to their maximum capacity. With all these factors in play, operating a GxP facility that complies with regulatory requirements is not easy, but doing so allows products to be manufactured and delivered safely under meticulous regulations and standards. At the same time, nonstop technological advances, meeting data integrity requirements, and the intense focus on vaccine production and distribution is shining a new light on regulation enforcement.
Regardless of the situation a business might find itself in, regulations require that manufacturers in health care industries, pharmaceutical companies, and small laboratories use equipment, systems, and processes that are up to date and fit for purpose. Applications range from manufacturing, packaging, and labeling to receiving and storage to testing and quality control.
Thanks to the rapid evolution of technology, regulatory requirements can seem slow to adapt, but industry practice is increasingly driven by two key factors: technological advances and quality requirements. As companies find new and better ways to create products and services, the bar for what is acceptable begins to rise with the latest quality standards that can be offered.
The importance of good practice quality guidelines and regulations
The intersection between long-standing regulations and new technology is often found in best practice guides published by accrediting bodies or professional associations like the International Society of Pharmaceutical Engineers. Organizations like this can leverage their members’ subject matter expertise in GxP compliance efficiently and then disseminate that information broadly to support a competitive and compliant life science industry.
The highest goal of these best practice guides is ensuring product safety, quality, and efficacy, which can be achieved through continuous monitoring. Handling of equipment, calibration, and maintenance, including temperature and humidity mapping, qualification, or validation of storage environments, must be performed to ensure conditions match the stability requirements of the products. This is where design-focused architecture and engineering, along with commissioning, qualification, and validation (CQV), become the key to compliance with current good manufacturing practice (cGMP) regulations. It’s important for facilities that will have cGMP activities to also meet those same standards.
Along with design and construction, GMP-compliant facilities benefit from CQV services, including design qualification, installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ). These services help ensure life science firms can efficiently start up, maintain, or renovate their facilities, utilities, systems, and equipment through risk-based commissioning and qualification. While little has changed regarding what is required for compliance with cGMP, the technologies used for commissioning, qualification, and validation have evolved.
How temperature mapping is currently performed
Temperature mapping is critical for businesses to stay ahead of the curve and immediately fix any issues that may arise when dealing with temperature-sensitive products. This process involves using sensors that record the temperature data for monitoring and analysis. The industry currently has a system for how this qualification is conducted. The standard procedure is for temperature mapping studies to be a part of the equipment installation and operational qualification process to demonstrate that a controlled environment is capable of accurate and repeatable performance.
However, the quality of a mapping study depends heavily on the quality of the protocols. Properly developed protocols help ensure that equipment meets documentation requirements and performs as expected. Generally, a protocol is a documented approach to qualifying an area or piece of equipment. It should include procedure details, scope, equipment description, responsibilities, test method, IQ/OQ test scripts, acceptance criteria, and approvals.
One of the most common concerns in quality control is maintaining the temperature of laboratory and manufacturing storage environments. Deviations in temperature can dramatically affect product quality, making management of controlled temperature chambers a critical practice.
cGMP, according to FDA regulations, requires that environments used to manufacture or process drug products be validated to ensure a high degree of quality and efficacy. Handling of equipment, calibration, maintenance, including temperature and humidity mapping, qualification, or validation of storage environments must be performed to ensure conditions match the storage specifications determined during stability testing of the products. This is also a requirement per international standards to ensure that the products are always stored and distributed within the specified temperature limits.
To ensure and demonstrate that proper environmental conditions and temperature and humidity controls are obtained, qualification and validation is expected to be carried out. The equipment used in temperature mapping studies to qualify storage areas has changed over the years. Traditionally, temperature mapping was all about thermocouples. Validation engineers needed to check their wires and sensor tips with that equipment, fixing them if required. From there, they had to wire up the sensor module, set up their mapping study in the software, connect all the components for calibration purposes, and run a calibration verification. All of this was done prior to even setting up a chamber for qualification.
This process is extremely time consuming, and the equipment is cumbersome. Today, firms are turning to more streamlined and efficient applications with continuous monitoring devices that connect to networks that can then inform when there is an issue that needs to be addressed.
Temperature mapping studies: equipment qualification
As part of the above process, it is vital that the tools used to gather this data meet specific guidelines and produce accurate readings. A properly developed qualification protocol will help ensure that the equipment meets all documentation requirements and performs as expected.
Part of this protocol involves ensuring the temperature mapping is correctly executed. A trusted CQV service provider can work with you to determine whether your qualification protocol is sufficient or help you generate a protocol to meet your requirements.
The IQ involves the standard operating procedures, and they extend to all the equipment, utility installation, documentation and drawings verification, calibration status of critical instruments, and test instrument calibration information. The OQ deals with operational controls and set-point verification, empty chamber temperature mapping, and alarm verification. Additional qualification tests may include open-door verification and a power-loss temperature test, but these two are usually for reference only. Finally, PQ is all about the loaded chamber temperature mapping study information.
The goals for these complex qualification and temperature mapping studies are to demonstrate environmental uniformity for temperature (and sometimes humidity), to identify unsuitable storage locations in an area, and to determine representative monitoring points. By following the steps listed previously, GxP validation engineers will be well on their way to successfully completing a temperature mapping study and be well-prepared for their next qualification.
Understanding how to be efficient in validation is an integral step to quality assurance and the many different aspects of compliance in life science industries. CQV is filled with documents, testing, and more, with many hours spent in the field or behind a desk. While validation and qualification might seem like long, drawn-out processes, there’s a good reason for them. If you can ensure your equipment or systems perform consistently and meet industry requirements, then the value of both the product and patient safety increases. When implemented in an optimized way, an effective CQV system can make a significant difference, generating more revenue for the company as well as helping to push innovation and competition across the industry.