Important Pharmaceutical Industry Guidance Documents and Standards

Guidance Documents

Following is a brief overview of several important industry guidance documents and standards. For additional regulations, guidances, and industry links, please click here.

Chinese Good Manufacturing Practices (GMP) for Drugs

The provisions of the Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, were enacted to regulate the manufacturing and quality management of Drugs in China. They went into effect in March 2011, two months after the USFDA issued its new process validation guidance document. The English translation for this document is now available for download.

The document introduces many key concepts from current GMP regulations in U.S., EU, as well as numerous standards/guidelines on quality systems. It also contains the following mandate for Water for Pharmaceutical Use: Water for pharmaceutical use should be suitable for its intended use, and meet the specifications of the Chinese Pharmacopeia and the related requirements. To view the full document, visit http://eng.sfda.gov.cn/WS03/CL0768/65113.html.

FDA Guidance for Industry - Process Validation: General Principles and Practices

The US FDA Process Validation guidance, issued in January 2011, aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. In this new guidance, the FDA strongly encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.

The FDA Process Validation document provides important new guidelines relevant to total organic carbon (TOC) monitoring. Key points are that continued process verification and control are an integral part of cGMP compliance, the analytical technology used for monitoring and control needs to be "scientifically sound," and the activities of engineering and utilities are inexorably linked to the overall quality system. Click here to read the full guidance document on the FDA web site, or learn more about how GE's Quality System Optimization (QSO) program can help companies use on-line TOC instruments to reduce costs, produce higher quality analytical results, and enhance process understanding.

ASTM E2656 - Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

Published in October 2010, ASTM E2656 provides a comprehensive framework for implementing on-line TOC instrumentation within pharmaceutical water systems that is in agreement with current regulatory thinking. The use of the standard allows users to comply with pharmacopoeia requirements while also meeting the regulatory expectations of greater process understanding and control. The standard is divided into six sections to assist in implementation. These include Technical Evaluation, Risk Assessment, Data Quality, Implementation Strategies, Continuous Verification Procedures, and Continuous Process Improvement. Learn more.  Purchase a copy of E2656 at the ASTM website, and/or download our application note entitled, "ASTM E2656: Process Control and Real-time Release Testing Using Total Organic Carbon."