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 manu facturing 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.