ABSTRACT
In this Guide “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control (QC), release, storage and distribution of APIs, and the related controls. In this Guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance (QA). For the purposes of this Guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.
