Common use of Laboratory Qualification Clause in Contracts

Laboratory Qualification. DSM is responsible for ensuring that all laboratories are in compliance with applicable cGMP’s guidelines. If analytical work is performed at DSM then Barrier will also provide any existing analytical documentation to assist in methods transfer or methods validation. In addition, if analytical work is not performed at the Greenville site, DSM may elect to perform an audit on vendors to be used for analytical testing. DSM will be responsible for insuring that any vendor selected by DSM is practicing within cGMP compliance. Vendors selected by Barrier must be certified by Barrier and acceptable per cGMP.

Appears in 2 contracts

Sources: Pharmaceutical Product Supply Agreement, Pharmaceutical Product Supply Agreement (Barrier Therapeutics Inc)