Tablets & Capsules

TC0318

Issue link: https://www.e-digitaleditions.com/i/947832

Contents of this Issue

Navigation

Page 15 of 55

14 March 2018 Tablets & Capsules You want to be confident that the CMO you choose will: • Minimize the potential for negative consequences, including damage to your brand and loss of market share and revenue. • Minimize product quality risks and ensure that the e q u i p m e n t , p r o c e s s e s , a n d p r o c e d u r e s u s e d i n manufacturing will maintain the intended strength, integrity, safety, purity, and quality of the pharmaceutical product. • Do it all within budget. While the right choice will be specific to each pharmaceutical company and its products and processes, this article will discuss some key factors to consider when selecting a CMO. Keeping these factors in line with your business goals will help you get your product to market in a safe, compliant, and cost-effective manner. Equipment and technology The CMO you choose must have the equipment and technology to successfully manufacture your drug product within specifications. You should evaluate the CMO's technologies and capabilities during the technical and commercial due-diligence period and during the initial audit activities for quality compliance. As you consider the CMO's capabilities, ask the following questions: Does your product have special handling or processing requirements? To determine whether a CMO has the proper technology and expertise for the job, evaluate your product's unique set of critical quality attributes (CQAs) and process parameters. Consider the following: • Does your drug product have special temperature requirements? • Is it susceptible to foaming or clumping? • Does it require some type of mixing or blending? • Is it shear-sensitive? • Is it sensitive to bio-decontamination or cleaning chemicals? • Is it highly viscous or temperature-, light-, or oxygen-sensitive? • Is it a controlled substance? Your answers to these questions will help you determine whether the CMO's equipment, technical competence, and resources are adequate to handle and process your product. Does the CMO have the right equipment? Evaluate whether the CMO has the necessary quantity and type of Make sure the CMO's staff has training and experience with all the technologies your manufacturing process requires.

Articles in this issue

Links on this page

Archives of this issue

view archives of Tablets & Capsules - TC0318