Amy Ritter is Scientific Editor, BioPharm International and Pharmaceutical Technology. Amy Ritter joined the editorial staff of BioPharm International and Pharmaceutical Technology in 2011. She received her BA in Biology from Boston University, and holds a PhD in Neurobiology from SUNY at Stony Brook. Before joining Advanstar’s Pharm Sciences group, she worked in the preclinical pharmacology group at Merck Research Labs, and is the author of numerous peer-reviewed scientific publications.

Amy Ritter

 the availability of the guidance “Q11 Development and Manufacture of Drug Substances” in the Nov. 20, 2012 edition of the

. The guidance was prepared under the auspices of the International Conference on Harmonization (ICH) and describes approaches to developing and understanding the manufacturing process of a drug substance, as well as providing guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information in the European Union, Japan, and the US.

According to the announcement, the final guidance contains revisions to the introduction and process development sections of the draft version of the guidance to more strongly emphasize that purification processes play a significant role in drug substance manufacture. The final guidance also incorporates revisions to the discussion of design space for chemical entities and biotechnological/biological drug substances, and revisions to the discussion of control strategy.

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FDA announced the availability of the guidance â€œQ11 Development and Manufacture of Drug Substancesâ€ in the Nov. 20, 2011 edition of the Federal Register.

FDA Adopts Final Version of Q11 Guidance

The US Pharmacopeia (USP) announced in a 

 a draft standard contained in the proposed 

. The draft standard contains best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

The proposed standard contains a section on importation that includes best practices for supply-chain risk management, development of effective supplier partnerships, and building a supply-chain quality system. Another section covers counterfeiting, including a definition of counterfeiting and best practices to combat counterfeit drugs and medicines. Included in the best-practices section are discussions of anticounterfeiting strategies such as the use of tamper-resistant packaging technologies and barcoding, as well as guidance for combating illegal Internet pharmacies. Finally, the guidance contains a section on diversion and theft.

In USP’s press release, Dr. Praveen Tyle, chief science officer of USP, says, “There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting bodies—to come to some agreement on hot-button issues such as track-and-trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply-chain integrity.”

USP is seeking feedback on the draft standard, which will be posted in the 

 38 (2), March–April 2012. The draft chapter and public comments will be the focus of the USP Supply Chain Integrity Workshop to be held on May 22–23, 2012, in Rockville, Maryland. The workshop will provide further opportunity to discuss the proposed standard and to decide if further information should be added.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.