Pharmaceutical Production, Data Management & GMP

How PST real-time monitoring technology plays a vital role in data integrity, quality & security

The effective management of data is essential to the success of almost every enterprise. For pharmaceutical manufacturing companies in particular the collection, organization, analysis and utilization of data from across the production lifecycle is mission-critical.

Data management is vital for a number of reasons:

• Process Optimization: Robust data modelling allows manufacturers to identify areas for improvement, streamline processes and optimize resources, thereby improving productivity and reducing costs.
• Batch-to-Batch Consistency: Regardless of the scale of manufacture, consistency of production is a key criterion to ensure uniform product quality and thus predictable therapeutic outcomes for patients.
• Continuous Improvement: The ongoing analysis of data from across the production infrastructure allows pharmaceutical manufacturers to identify trends and potential issues, and to implement preventive measures or process refinements.
• Quality Control: Accurate and comprehensive data management is an essential aspect of quality control and adherence to correct production and product specification.
• Regulatory Compliance: Ultimately, data integrity and traceability are crucial to demonstrate that every stage of the pharmaceutical production process, from research and development to the point of delivery, meets the highest regulatory standards to protect consumer safety and corporate reputations.

Data management & GMP

Data management is also fundamental if pharmaceutical manufacturers are to comply with the requirements of Good Manufacturing Practice (GMP). The World Health Organization defines GMP as ‘a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. … GMP covers all aspects of production: from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made’.

Clearly, none of this can be achieved without robust procedures for collecting, analyzing and interpretating data, and then for using the resulting information for real-time production control and optimization, and for ongoing reporting and compliance.

Data management for GxP applications

The good news is that the recent explosion in digital technologies, driven by initiatives such as Industry 4.0 and its pharmaceutical manufacturing equivalent Pharma 4.0, being developed by the International Society for Pharmaceutical Engineering, is bringing a new generation of advanced, intelligent systems to the industry. These technologies are creating exciting opportunities for development, production, quality and supply chain engineers and managers to take levels of productivity, product quality, traceability and regulatory compliance to fresh heights.

Leading this movement are solutions such as our Realtime Monitoring System (RMS). D This innovative platform combines GAMP5 category 4 software with Category 1 hardware und exploits the power of digital technology to help manufacturers focus on the key challenges of data capture and integrity.

An RMS solution typically incorporates a network of hard-wired and wireless sensors, probes and data loggers connected to an on-premises or secure cloud-based database and analytics software platform. This allows, for example, temperature, relative humidity, differential pressure or gas concentrations to be measured, with data from each device being automatically captured by the system software. The latter then provides a range of features including multi-level access, customizable user dashboards, real-time remote monitoring with alarms and interactive alerts, plus automatic report generation and validation scripts.

The RMS platform is straightforward to install and configure, and complies with EudraLex EU Annex 11  and FDA CFR 21 Part 11, making it ideal for use with all GxP processes, including GLP, GMP and GDP. Its modular design makes it easy to scale, enabling it to be rolled out in a single process area, such as a cleanroom, and then once the concept has been proven to be scaled up across the entire production infrastructure.

Regardless of the nature or scale of the implementation, RMS technology provides pharmaceutical manufacturers with a wealth of high integrity data on which they can rely. Together with a powerful monitoring and analytics platform, this creates fresh opportunities for improving process optimization, utilization, quality, consistency and, most importantly of all, regulatory compliance.

Learn how our modular Rotronic monitoring system can enhance pharmaceutical manufacturing checklist lab rms

Weitere Informationen

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