Compliance

It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.

In China, the industrial and regulatory landscape has been evolving rapidly – and in particular as it relates to generic drug products. In 2015, the China State Council announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44). At this same time, a series of reforms were announced by the National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to upgrade the pharmaceutical industry by raising marketed products to international standards in terms of quality, safety and efficacy.

Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.

West has been busy behind the scenes building our offerings in the West Knowledge Center. The Knowledge Center launched just over a year ago, and since then we’ve more than doubled our content based on customer requests and real-time data and analytics.

In the next blog of our series on West’s 2017 Corporate Responsibility Report, we are focusing on Compliance and Ethics. As a company that operates in a highly regulated industry to serve billions of patients around the world, it is imperative that West conducts its business in an ethical manner – not because we have to, but because it’s the right thing to do. Read on to learn more about compliance and ethics at West as published in the 2017 Corporate Responsibility Report.

We are proud to announce our inaugural Corporate Responsibility Report. West’s commitment to sustainability and remaining active in the areas where we live and work are integral to West’s culture. In Parts 1-3 of this five-part blog series on the report, we focused on West’s efforts in Compliance and Ethics, Philanthropy and Diversity.

The fourth part of the five-part series on West’s Corporate Responsibility discusses West’s Health and Safety programs.