All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved, and distributed according to written procedures. Such documents can be in paper or electronic form. The issuance, revision, superseding, and withdrawal of all documents should be controlled by maintaining ...

Out-of-Specifications Deviations of products from pre-determined specifications. This means when a product is unable to meet the predetermined limit for that particular product. There are several possibilities that could account for this deviation. These possible reasons for out-of-specification can ...

Specification: A document giving a description of a starting material, packing material, intermediate bulk or finished product in terms of its chemical, physical and biological characteristics. The International Conference on Harmonization (ICH) defines specifications as “a list of tests, references ...