Outsourcing Clinical Supplies Manufacturing
Part 1: Navigating US Import Laws
Revenue for contract manufacturing of bulk and dosage form drugs reached $48.6 billion
worldwide in 2010 and is projected to reach $86.3 billion by 2016, increasing at a compound
annual growth rate of 10.1%.1 Many contract manufacturing organizations (CMOs) are now
Figure 2. Clinipace
Approach to
Clinical Supplies Manufacturing
located outside of the US or EU, and this shift presents significant challenges to ensuring both
the quality of the supply chain and the timeliness of receiving products intended for clinical or
commercial distribution.
Figure 1.
Within the Regulatory and Strategic Development (RSD) division
Revenue for Contract
of Clinipace, our international team of quality assurance and
Manufacturing of Bulk &
Dosage Form Drugs Worldwide
regulatory professionals assists clients with these challenges
every day. The cornerstone of our approach is a set of quality
systems (defined within SOPs) that are applied to the qualification,
selection, and management of contract manufacturing organizations
(CMOs) for virtual companies and sponsors of clinical trials. These
documents delineate roles, set up the infrastructure for SOPs, and
address key issues such as batch release, training, and change
control. Many of these procedures should be established before
the CMO is selected, and almost all should be put in place before
the actual manufacturing of the active pharmaceutical ingredient
(API)/drug product begins.
With our clients, we also emphasize the need to decide up front if the drug supplies will be
imported into the US, the EU, or both, as the rules and regulations vary by region/country.
Understanding the labeling, documentation, and timing requirements for importation is
critical, as changes late in the process can significantly delay time lines. This white paper,
part 1 in a series, focuses on a change in the standard practice in the import of clinical trial
supplies into the US. After reviewing the law, we explore the implications of the change and
offer suggestions about overcoming this latest hurdle.
clinipace.com
1