5.3 Material/Component Storage and Handling

This page will address various regulatory issues related to this section of the GMP Institute framework.  Click below to view the issues that are relevant to you.

Are firms required to perform an identity test on an approved component (either an active or inactive) after it has been moved to an off site warehouse and then returned to the manufacturing facility for production?

Are firms required to perform an identity test on an approved component (either an active or inactive) after it has been moved to an off site warehouse and then returned to the manufacturing facility for production?

References:
211.42(b) and (c)(1-3).

No, it is not necessary to repeat the identity test if the component lot was securely packaged for storage at the off site location to reduce the risk of mix-up and protect lot integrity, otherwise held under CGMP compliant conditions (including adequate segregation), and properly labeled. As with other types of contracted manufacturing and testing facilities, the warehouse becomes an extension of the manufacturing site and both the manufacturer of the dosage form and the warehouse are responsible for ensuring compliance with the appropriate CGMP regulations, e.g., 211.42(b) and (c)(1-3). This applies to active as well as inactive components. The off site warehouse, however, is not required to register.

Contact for further information: Brian Hasselbalch, HFD-325; phone: (301) 827-7283;
e-mail: hasselbalchb@cder.fda.gov

This same text is also reprinted in Framework section 5.2.