(1999; 168 pages) [Spanish]
5.2 Starting materials
The excipient manufacturer should verify that the supplier of starting materials and components can meet the agreed-upon requirements. This may require periodic audits of the vendor's plant if necessary. Purchasing agreements should contain data clearly describing the product ordered including, where applicable, the following:
• The name, type, class, style, grade, item code numbers or other precise identification as appropriate.
• Drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or verification of product, procedures, process equipment and personnel.
Starting materials, including solvents and recovered solvents, are sometimes stored in silos or other large containers, making precise separation of batches difficult. Usage of such materials should be demonstrated, via inventory or other records, with reasonable accuracy.
When purchased and recovered solvents are commingled, the suitability of the recovered solvent must be demonstrated through either validation or actual testing. The purchased materials should comply with existing specifications.
Outdoor storage of starting materials (e.g. acids, other corrosive substances, explosive materials) is acceptable if the containers give suitable protection to their contents, identifying labels remain legible and containers are adequately cleaned prior to opening and use.