GMP temperature control for contract pharmaceutical manufacturers

Digital monitoring improves production control & traceability

Contract pharmaceutical manufacturers wanting to build successful GMP models, with the highest standards of quality, need to consider a combination of factors. These include the development of effective procedures, systems and management processes, underpinned by accurate and consistent collection, analysis and interpretation of data, collated from across the production infrastructure. In the past, this has been a time and labour-intensive activity that has often been frustrated by limitations of the available monitoring and control technologies.

Today, with the advent of advanced digital process sensors (e.g. TCD-S-001), instruments and control systems, the options open to production, validation, quality and calibration engineers and managers have been transformed. In particular, digitization has significantly enhanced the ability to capture and analyze data in real-time, improving production control and traceability. This also extends the ability of contract pharmaceutical manufacturers to demonstrate to customers that they are fulfilling contractual obligations and working to protect customers’ interests and reputations.

GxP-compliant temperature monitoring and control

The control of temperature across the production infrastructure, from cleanrooms to warehouses, is one of the most widely used control criteria in the pharmaceutical sector and forms an important aspect of many pharmaceutical regulations and guidelines – you can read more about these in our technical application stories.

Developing an effective temperature monitoring and measurement approach is, with the latest digital technology, relatively straightforward and can be achieved at realistic cost. For example, our Rotronic Realtime Monitoring System (RMS) provides a modular, scalable and GMP-compliant hardware and software solution, with the option of continuous on-site or securely encrypted cloud-based data storage and analysis.

In a typical application, a centralized RMS monitoring unit running RMS Gamp5 category 4 software can be used with multiple new or existing analog and digital sensors, including those from most third-party suppliers. This allows installed equipment such as sensors or data loggers to be retained and integrated using hard-wired or wireless connections into the process-wide RMS network, with complete data integrity and compliance to EudraLex Annex 11 and FDA 21 CFR Part 11.

Among the many advantages of the RMS solution is the ability to customize its architecture to meet the specific needs of each pharmaceutical manufacturing operation, and to create dedicated access levels and reports for multiple users. Additionally, the RMS can be configured for inputs from a wide range of measurement criteria, including temperature, relative humidity and differential pressure, creating a comprehensive audit trail and full traceability as part of GMP.

Best monitoring practices for contract pharmaceutical manufacturing

Regardless of the power and flexibility of systems such as RMS, they will only ever be truly effective if they are supported by robust operating procedures and staff training. Advanced digital monitoring systems should therefore be considered from the outset as being integral to the development of best practice procedures, for new installations and system upgrades alike. For example, when planning and implementing temperature monitoring and control systems, consider the following:

• The need for comprehensive Standard Operating Procedures (SOPs), which outline temperature monitoring and control protocols. SOPs should cover procedures such as installation procedures, testing, routine checks, data recording and equipment calibration.
• Thorough and regularly updated training for staff involved in temperature monitoring and control. This includes educating them about the importance of maintaining temperature stability, familiarising them with monitoring equipment and ensuring they understand SOPs and regulatory requirements.
• Regularly validate temperature monitoring and control systems to ensure that they are operating accurately and reliably. This involves regular performance checks, calibration and the production of supporting documentation to comply with regulatory guidelines.
• Maintain comprehensive records of temperature monitoring and control activities. This documentation serves as an audit trail, demonstrates compliance with regulatory standards and ensures traceability.
• Conduct risk assessments to identify potential temperature related risks and implement appropriate mitigation measures. Use the power of digital monitoring systems such as RMS to build a proactive model that ensures that process criteria are maintained within approved limits and enables you gradually to optimise process conditions to improve product quality, consistency and production output.

Ultimately, the advances in digital temperature monitoring and control technologies mean that contract pharmaceutical manufacturers have the tools with which to improve still further the quality, productivity and compliance of their production and supply chain operations.

Learn more about how our modular Rotronic monitoring system can enhance pharmaceutical contract manufacturing processes:

Related Information

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Pharmaceutical Temperature Monitoring
Rotronic Monitoring System Overview

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