definiens: documents will define the process, plant, in - process specifications, critical parameters, the API specification and methods, packaging specification, sampling requirements and storage conditions . RPS shall also ensure that corresponding baseline documents covering Powdersize or MT 's activities are prepared by powders ~ ze or MT respectively . RPS will formally review and approve the MT or Powdersize documents prior to the first milling of API for human use . RPS shall provide to CTI a copy of both sets of baseline documents for review and approval and to faciliate compilation of regulatory dossiers . This will be done prior to manufacture of any API for human use so that the documents reflect the intent for ongoing commerical supply ( i.e. prior to the initial NDA batches ) . Updated copies of the relevant baseline documents will be sent to CTI ( as appropriate ) for review in the following circumstances : • whenever a change is made to the basic synthetic route, to the site of manufacture ( e.g. prior to manufacture and validation on moving from Dudley to Annan ) or to the API specification • whenever an API analytical method is replaced Thereafter CTI will review and approve changes as detailed in Section 7 . RPS will provide copies of other master documents relating to the manufacture and testing of the API to CTI at CTI 's request