Common use of Master Batch Records Clause in Contracts

Master Batch Records. (a) POLYPEPTIDE will prepare Master Batch Records to include directions in sufficient detail to manufacture the bulk drug substance under cGMP guidelines. INTRABIOTICS reserves the right to review and approve the Master Batch Records prior to their use in the production of intermediates or bulk drug substance. (b) POLYPEPTIDE will notify INTRABIOTICS of proposed changes to the Master Batch Record in advance of the proposed implementation. A verbal telephone call outlining significant changes to responsible person is acceptable, but shall be confirmed in writing; telefax transmission is acceptable. INTRABIOTICS acceptance or rejection of the proposed changes will be provided in writing before implementation; telefax transmission is acceptable. (c) INTRABIOTICS shall be notified about proposed deviations in a timely manner. INTRABIOTICS will respond to proposed deviations in writing; telefax transmission is acceptable. (d) Master Batch Record changes shall be finalised in typed written format and approved in writing by representatives of both POLYPEPTIDE and INTRABIOTICS.