API COP E-Letters

E-Letters

E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

April 2011

ICH Q11 Authors to Present at ISPE Washington Conference
Industry and US FDA members of the ICH Q11 Expert Working Group who authored the guideline will provide background on the origins of Q11, key concepts contained in the guideline, and the progress made towards harmonization. Organized by the Science-Based Regulations Subcommittee of the ISPE API Community of Practice, “Are You Ready for ICH Q11 and Beyond? Emerging Topics in the API Global Regulatory Environment” will be held 8-9 June at the ISPE Washington Conference. More ( 87 KB) .

US FDA on Final Process Validation Guidance: Focus on Concepts, Not Terminology
The final Guidance for Industry – Process Validation: General Principles and Practices outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances). ISPE 2011 Tampa Conference attendees in February were the first to hear direct from the FDA the agency’s thinking behind the final guidance. More.

New Risk-MaPP Resources: Blog and FAQs
ISPE published the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in September 2010. The Guide provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. The Guide has generated much discussion. In response to industry needs, ISPE has set up a blog and developed an FAQ document dedicated to the issues related to the Risk-MaPP Baseline Guide. More.

What the API Community is Discussing Right Now
WFI system for an API sterile plant, re-validation, and blending of out-of-specification batches continue to be hot topics of discussion at the API Community of Practice site. More.

January 2011

Are You Ready for ICH Q11 and Beyond?
The Science-Based Regulations Subcommittee of the ISPE API Community of Practice is organizing an ISPE Washington Conference Seminar on the new ICH guideline Q11 for the Development and Manufacture of Drug Substance. Read more ( 87 KB) .

Overview of API COP Science-Based Regulations Subcommittee
The mission of the API COP Science-Based Regulations Subcommittee (SBRS) is to improve patient safety and timely delivery of medicines through partnership with regulating agencies by developing and promoting risk-based and science-based regulatory positions for the development and manufacture of API.

What the API Community is Discussing Right Now
Is there any method or procedure to check the endotoxin level in raw materials used for manufacturing? How do you ensure that your process is robust to raw material variability? Your colleagues would like to hear your thoughts on these and other topics under the Community Discussions section at the API Community of Practice site. Read more.

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