Understand ICH Q7 S10

What is meant by ‘appropriate specifications (of each batch) prior to blending’ [ICH Q7, 8.41]? 

As a principle, no batches with Out of Specification (OOS) results should be blended [ICH Q7, 8.41]. Blending is defined in [ICH Q7, 8.40]. Individual intermediate and/or API batches should demonstrate conformance with the filed specifications prior to blending. In regions or circumstances where there are intermediates and/or APIs that do not require filing, conformance with the release specification should be demonstrated. 

What is meant by ‘APIs and intermediates can be transferred under quarantine to another unit under the company’s control when...’ and is this applicable to contract manufacturers?

ICH Q7, 10.20] states ‘APIs and intermediates should only be released for distribution to third parties after they have been released by the quality unit(s). APIs and intermediates can be transferred under quarantine to another unit under the company’s control when authorized by the quality unit(s) and if appropriate controls and documentation are in place’. The second sentence in [ICH Q7, 10.20] describes transport situations that are not considered distribution. It provides for physical movement (transfer but not release) of quarantined material to another unit. This unit can be on the same site, different site (within the same company), or a contract manufacturer (see final paragraph below). The goal of transfer under quarantine is to allow transportation and testing in parallel. Material that is transferred under quarantine is not to be used for further processing until all testing and quality review is complete and the material is released by the quality unit as defined in [ICH Q7, 2.22]. This provision for transfer under quarantine is included in ICH Q7 for situations where a company is shipping APIs or intermediates from one unit to another and has both the need to expedite the shipping and the material management system in place to prevent use of the material before full release. Examples of circumstances where transfer under quarantine may be needed include extraordinary supply chain requirement(s) (e.g., short shelf-life), and materials with a lengthy timeframe for required test(s) (e.g., some microbiological tests, etc.). With appropriate oversight as described in [ICH Q10 2.7], including a written agreement as described in [ICH Q7, 16.12], and appropriate ongoing controls, a contract manufacturer may be considered a ‘unit under the company’s control’. There is a joint responsibility by both parties to clearly justify and document the need to transfer the unreleased intermediate or API, and to ensure appropriate control is maintained to prevent use before full