PCI 7 November 2023, 15:44
Temax_Krautz
Owen Mumford 12 January 2022, 17:40

Current Edition

Technology’s Role in Pharmaceutical Manufacturing Excellence 


Pharmaceutical manufacturers face increasing compliance demands to ensure the identity, strength, quality, and purity of drug products. As a result, systems used within manufacturing processes must adhere to current Good Manufacturing Practice (GMP) guidelines enforced by regulators like the US Food and Drug Administration (FDA). GMP regulations require drug manufacturers, processors, and packagers to take proactive steps to ensure drugs are produced consistently and that their products meet quality standards for strength, purity, and efficacy.


These core ambitions of the regulations are to prevent errors in the manufacturing process to protect the consumer from purchasing a product that is potentially ineffective or even dangerous. While GMP is applicable to a number of industries, the consequences of failing to follow these guidelines within pharmaceutical manufacturing can have serious consequences by compromising the safety and efficacy of the final product. Failure of firms to comply with GMP regulations can result in severe repercussions, including product recalls, seizures, organisational fines, including consent decrees, and, in some countries, individual jail time. 

End-to-end GMP Compliance can Support Drug Development

The success rate of drug candidates that make it through phase I, II, and III clinical trials is just 10%. However, industry adoption of new technologies that support the drug discovery workflow is making improvements, including software that is used for the collection, management, and storage of data and documentation.

When you consider the time and money involved in drug discovery and the ratio of successes to failures, it is understandable that once a drug is approved, pharmaceutical companies look to maximise revenues and longevity. While pharmaceutical manufacturing is often seen as the final stage in the drug development lifecycle, it is a vital part of a drug’s ongoing monetisation, requiring precision, accuracy, and a hyper-focused approach to quality.

Pharmaceutical companies and CDMOs adhere to GMP regulations as the benchmark to maintain manufacturing excellence. As drug design grows more complex with the development of novel therapies, from personalised and precision medicines to gene therapy and mRNA vaccines, regulatory bodies increase oversight, and shareholders look for improved return on investment, the industry finds itself navigating a landscape where technology is no longer just an asset in the manufacturing process; it is of paramount importance.

Integrating GMP-compliant Technologies to Support Pharmaceutical Manufacturing

The integration of a Laboratory Information Management System (LIMS) into drug discovery and development workflows serves as a useful tool to streamline data management and automate reporting workflows, resulting in time and cost benefits, important considerations for pharmaceutical companies looking to reduce timelines from drug development through to regulatory approval.

To maintain GMP compliance when integrating a LIMS, it is important to consider the advantages of using a LIMS that can support GMP-validated processes and documentation. Configuring a LIMS system to support these processes ensures compliance with stringent regulatory requirements and provides a robust framework for managing the volume and variety of processes involved in pharmaceutical manufacturing.