The U.S. Pharmacopeial Convention (USP), a global health organization that aims to improve lives through public standards for foods and medicines, hosted a seminar on pharmacopeial and regulatory compliance at CPhI China 2015 to help industry leaders and experts deepen their understanding of the latest quality standards and regulatory updates.
Former officials from U.S. FDA, experts from USP and the Chinese Pharmacopoeia Commission (ChP) as well as senior executives from pharmaceutical companies were invited to deliver keynote speeches. Over 120 industry leaders and executives from domestic pharmaceutical companies participated in the seminar.
“In recent years, we’ve seen an increasing number of Chinese pharmaceutical companies that are expanding internationally. It is necessary for these companies to be compliant to the latest pharmacopeial quality standards and regulations in order to run businesses in a stringent regulatory market.
“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply and also guide them to contribute towards shaping global standards,” said Dr. Feng Bingbing, chairman of the seminar and USP-China General Manager.
The USP seminar focused on key industry concerns related to global and local pharmacopeial standards and regulations. Industry’s concerns are closely aligned with recent efforts made by the Chinese government to step up the regulation of local quality and safety standards, strengthen compliance monitoring and enforce strict penalties and related accountability for food and medicines safety. Other key event highlights include:
- USP’s requirements for elemental impurities (which will replace USP’s existing standard for heavy metals) effective in 2018;
- US FDA’s new initiative, the Quality Metrics Program, and the use of big data to improve regulatory effectiveness;
- US Generics Market Overview: Opportunities and challenges for Chinese companies;
- ChP 2015 Overview, which is to be effective by December 1, 2015.
"China is a major exporter of raw materials for pharmaceuticals, and increasingly for drug products, throughout the world. USP places great importance on the Chinese market, and we are committed to supporting the growth of local industry. To this end, we have built R&D and training facilities with an area of 10,000 square meters in the Shanghai Pilot Free Trade Zone to better serve their needs. We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments and improve public health,” said Dr. Feng Bingbing.
CPhI South East Asia-Jakarta 8 - 10 April 2015
CPhI Japan 22 - 24 April 2015
CPhI Russia 27 - 29 April 2015
CPhI Istanbul 3 - 5 June 2015
CPhI and P-MEC China 24 - 26 June 2015
CPhI South America 25 - 27 Aug. 2015
CPhI Korea 7 - 9 Sept. 2015
CPhI Worldwide Madrid 13 - 15 Oct. 2015
CPhI and P-MEC India 1 - 3 Dec. 2015
When it comes to drugs, most of the attention goes to the active pharmaceutical ingredient. But typically the vast majority of what’s in a tablet, capsule, or liquid isn’t the active ingredient. A drug is formulated with many other compounds, called excipients, that play an essential role in delivering the active ingredient to the patient.
Lubricants, for example, make a bulk material easier to handle in a manufacturing facility. Fillers may be added to make small doses, such as 5 mg of an antihistamine, physically large enough for a person to handle easily. Fillers may double as binders to help hold a tablet together. Coatings protect a tablet from moisture or light or mask an unpleasant flavor. Disintegrants help a tablet fall apart in the digestive tract to release the active drug.
The pharmaceutical-standards-setting organization U.S. Pharmacopeia (USP) counts nearly 500 excipients in its National Formulary. The global excipients market was $5.9 billion in 2012 and is expected to reach $8.8 billion in 2018, according to market research firm BCC Research.
Despite the crucial role that excipients play in getting drugs successfully into patients, some regulatory analytical procedures for excipient quality control are decades old. These methods do not meet modern expectations for analytical rigor or actually test that a product is what’s said on its label. What’s more, excipients are not exempt from rising anxiety in recent years about the integrity of global pharmaceutical supply chains. In one instance, counterfeiters substituted less expensive and toxic diethylene glycol for glycerin in cold medicine sold in Panama in 2006, killing at least 100 people. In response to these concerns, USP, in collaboration with the U.S. Food & Drug Administration and similar organizations around the world, is working on updating analytical requirements for excipients.
It’s an effort that’s easier said than done. Many excipients are not cleanly synthesized small molecules. Instead, they may be analytically challenging materials that are polymeric, prepared from animal or plant material, or mined. Also, the markets for industrial or food uses for a particular product often far outweigh the pharmaceutical excipients market. Manufacturers may not see a strong need to continue to supply the pharmaceutical industry if they’re faced with buying expensive instrumentation that requires highly skilled operators. Raising analytical standards is consequently a balancing act between ensuring the safety of pharmaceuticals and preserving the excipient supplies to formulate them.