21 CFR 211.101 - Charge-in of components.
Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:
(a) The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient.
(b) Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information:
(c) Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:
(3) The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure paragraphs (c)(1), (c)(2), and (c)(3) of this section.
(d) Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under § 211.68, only verified by one person.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.