10. STORAGE AND DISTRIBUTION

10. STORAGE AND DISTRIBUTION
10.1 Warehousing Procedures
10.10 Facilities should be available for the storage of all materials under appropriate conditions (e.g. controlled temperature and humidity when necessary). Records should be maintained of these conditions if they are critical for the maintenance of material characteristics.
10.11 Unless there is an alternative system to prevent the unintentional or unauthorised use of quarantined, rejected, returned, or recalled materials, separate storage areas should be assigned for their temporary storage until the decision as to their future use has been taken.
10.2 Distribution Procedures
10.20 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.
10.21 APIs and intermediates should be transported in a manner that does not adversely affect their quality.
10.22 Special transport or storage conditions for an API or intermediate should be stated on the label.
10.23 The manufacturer should ensure that the contract acceptor (contractor) for transportation of the API or intermediate knows and follows the appropriate transport and storage conditions.
10.24 A system should be in place by which the distribution of each batch of intermediate and/or API can be readily determined to permit its recall.