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48 March 2017 Tablets & Capsules identify appropriate analytical methods and reference standards to test for the absence of asbestos in talc. The specifi- cation will be shared with the PDG members for consideration as a revision to the currently harmonized Talc monograph [13]. Global excipient harmonization initiatives To help meet the challenges of global excipient manufacturing and supply chains, USP collaborates with other pharmacopeial organizations worldwide to harmonize excipient monograph specifications, such as test procedures and acceptance crite- ria. Recent progress on these initia- tives includes: • In September 2016, USP signed a Memorandum of Cooperation with JP establishing a framework for col- laborative work between the two organizations that includes excipients. • In October 2016, USP renewed a Memorandum of Understanding (MOU) with the Chinese Pharma- copoeia (ChP), to establish a frame- work for collaborative projects between the two organizations over the next 3 years. Under this MOU, we will collaborate to strengthen standards in our respective pharmacopoeias and participate in joint standard-setting and harmonization activities that include excipients. Following the MOU sign- ing, USP and ChP held a joint work- shop focused on advancing quality in regulatory science. • Since 1989, USP has partici- pated in the PDG, which aims to harmonize excipient standards among USP, PhEur and JP. PDG has harmonized 30 of 36 General Chapters and 49 of 67 excipient monographs on its work plan [6]. USP attended the PDG meeting in Tokyo, Japan on October 24-26, 2016, to discuss the PDG work plan, including signing off on the new Color General Chapter [14]. Progress has also been made on four of the recently added items: isostearyl alcohol, myristyl myristate, polysorbate 65, and sodium cetyl sul- fate. JP has been confirmed as the coordinating pharmacopoeia for these monographs, and the draft texts provided to USP will also be provided to PhEur for comment in accordance with the PDG procedure. USP excipient stakeholder engagement USP continued to expand oppor- tunities to engage with global excipi- ent stakeholders by hosting its third Excipients Stakeholder Forum in September 2016, which discussed progress and stakeholder achieve- ments on the USP Excipient Up-to- Date initiative. The forum was cre- ated to foster exchanges of information and perspectives between USP and users of USP standards to improve those standards. It provides opportunities for manufacturers, dis- tributors, and users of excipients to discuss topics in an open setting. USP found that the Stakeholder Forum encourages excipient constituencies to work openly and directly with USP and to collaborate with fellow stakeholders [15]. USP workshops are another activ- ity designed to promote the exchange of ideas across a wide range of current scientific findings, regulatory trends, and public health topics. Workshops are open to all interested parties. USP and FDA co-sponsored a workshop on standards for pharmaceutical products, "Critical Importance of Excipients in Product Development: Why Excipients are Important Now and In the Future" in late February [16]. The workshop discussed how the quality and variability of excipi- ents impact medicines. The workshop helped participants: • Develop a strategy on excipient selection for complex drug products [17, 18]; • Understand the FDA's position on Q1/Q2/Q3 in terms of risk assess- ment for product quality and clinical performance; and • Recognize and understand the importance of excipient selection suit- able to the drug product and process. Conclusions USP's up-to-date monograph qual- ity specifications help improve testing controls and provide tools to use in qualifying an excipient for its intended use. In combination with other suitable controls on excipient quality, compen- dial testing plays a very important role in ensuring the quality of pharmaceuti- cal products [1]. Supported by the FDA, and by public and industry out- reach efforts, the USP monograph up- to-date and harmonization initiatives continue to increase the relevance and quality of excipient standards in fur- therance of USP's stated mission of improving global public health. USP welcomes participation and contribu- tion—including revisions to mono- graphs, donation of bulk material to be developed into reference standards, and shared expertise—from interested parties in our collaborative standards- setting activities [19]. T&C References 1. Challenges and Opportunities in Developing Up-to-Date USP-NF Excipients. G. Holloway, C. Sheehan, H. Wang. American Pharmaceutical Review. September/October 2015, p. 48. 2. USP Excipient Monograph Modernization List. Online. Accessed Jan 15, 2017. 3. Guideline for submitting requests for revision to USP-NF. Online. Accessed Jan 20, 2017. 4. Submission guidelines for excip- ients. Online. Accessed Jan 20, 2017. 5. Expert panels provide support to the expert committees by con- tributing additional expertise beyond that of the Expert Committee (which is global in make-up) and present rec- ommendations to the expert commit- tees upon completion of their charge. 6. Pharmacopeial Discussion Group. Online. Accessed Jan 15, 2017. 7. Challenges and Opportunities in Developing Up-to-Date USP-NF Excipients, T.J. Liu, C. Sheehan, and S. Wolfgang, American Pharmaceutical Review, May/June, 2016, p. 32. 8. Challenges and Opportunities in Developing Up-to-Date USP-NF Excipients, T.J. Liu, K. Moore, C. Sheehan, American Pharmaceutical Review, January/February, 2016. 9. Council of Experts Expert Committee work plans. Online. Accessed Jan 15, 2017.