Raw Material Specifications and Acceptance Sample Clauses
The Raw Material Specifications and Acceptance clause defines the standards and criteria that raw materials must meet before being accepted for use in production or delivery. It typically outlines the required quality, grade, and testing procedures for incoming materials, and may specify the process for inspection and rejection of non-conforming goods. This clause ensures that only materials meeting agreed-upon specifications are used, thereby maintaining product quality and reducing the risk of defects or disputes over material suitability.
Raw Material Specifications and Acceptance. Criteria—Transfer and document acceptance testing methods and specifications for ORPHAN review and approval. Evaluate currently approved vendors. If supplier of critical raw materials are not previously audited, conduct audits. Audit reports on vendors of critical raw materials will be provided to ORPHAN for review. DMF Reference Authorization letters from suppliers of any commercial combination excipients and activities must be obtained and included in the submission. Certificates of Analysis and batch numbers for raw materials will be maintained.