35th Anniversary Special: The Transformation of Regulation and Global Standards - Pharmaceutical Technology

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35th Anniversary Special: The Transformation of Regulation and Global Standards
How FDA, USP, and ICH have redirected industry practice.


Pharmaceutical Technology
Volume 36, Issue 7, pp. 45-49

The International Conference on Harmonization (ICH)

In this author's opinion, the establishment of ICH has had the most influence on the pharmaceutical industry. The first ICH meeting was held in 1990 and the body of work produced by this organization and its impact on the industry is staggering. ICH's work has changed our language and established global stability requirements, and GMPs for APIs, and laid the foundation for the modern quality system.

ICH Q2 Validation of Analytic Procedures (1994). This document established validation requirements for analytical tests, including identifications, quantitative impurities, controlled impurities, and active moiety. It standardized industry terminology for the various parameters needed for validation, including definitions for specificity, accuracy, precision, repeatability, linearity, robustness, and reproducibility. The EU, MHLW, and FDA adopted the document and it continues to define how the industry approaches analytical methods validation.

ICH Q7 GMP Guide for APIs (2000). This document provided the first comprehensive GMPs for APIs. It touched on everything from the necessary quality management to personnel qualifications to the design and construction of the buildings and facilities. Adopted by the EU, MHLW, and FDA, it serves today as the gold standard for API manufacturing requirements.

ICH Q10 Pharmaceutical Quality System (2008). Adopted by the EU, MHLW, and FDA, this harmonized guideline was the first to define the modern quality system and to discuss how it should be integrated into all aspects of the pharmaceutical business. The document recognized that Quality should not be a stagnant policing organization but a vibrant organization concerned with "continual improvement of process performance and product quality throughout the product lifecycle." It openly discussed management responsibility and challenged the industry to consider that management of outsourced activities was a crucial element of a quality system. The impact of this document on the industry is still being discussed at conferences, and companies are implementing many of its requirements.

ICH Q11 Development and Manufacture of Drug Substances (2012). Released in May 2012, this guideline has only been adopted by the EU to date. Q11 describes approaches to developing and understanding the manufacturing process of the drug substance, and offers guidance on what related information should be included in the Common Technical Document (CTD). The impact of Q11 is currently unknown but this author is sure it will follow the tradition of the other ICH documents.

As outlined herein, there have been rnage several changes in the pharmaceutical industry during the 35 years that Pharmaceutical Technology magazine has been in existence. A broader industry timeline is contained within these anniversary pages as well. Let's hope the next 35 years are as exciting and successful as the past 35.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
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Source: Pharmaceutical Technology,
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