Standardisation within pharmaceutical manufacturing entails the development, implementation, and adherence to uniform standards, specifications, protocols, and guidelines. This process ensures consistency, reliability, and compliance with quality standards and regulatory requirements across all facets of production, from procedures and methods to practices and systems. By fostering a common framework of terminology, methodologies, and requirements, standardisation enhances communication, collaboration, and efficiency, facilitating seamless integration and interoperability of products and technologies. Led by international, national, or industry-specific standards organisations, standardisation efforts in the pharmaceutical sector are crucial for promoting innovation, competitiveness, and market acceptance, ultimately ensuring the delivery of high-quality, compatible, and interoperable products.
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