(1999; 168 pages) [Spanish]
The excipient manufacturer should have a system to cover all documents and data that relate to the requirements of the quality system. Documents, and subsequent changes to the documents, should be reviewed and approved by designated personnel before being issued to the appropriate areas identified in the documents. A record should be kept of where the documents are located.
The following minimal requirements for documentation should be applied:
• To assign a unique batch number to the excipient to be released and/or certified.
• To prepare a batch record.
• To demonstrate that the batch has been prepared under GMP conditions from the processing point at which excipient GMP have been applied.
• To demonstrate that the batch is homogeneous within the manufacturer's specifications. This does not require a final blending of continuous process material, if process controls can demonstrate compliance with specifications throughout the batch.
• To demonstrate that the batch has not been commingled with material from other batches for the purpose of either hiding or diluting an adulterated substance.
• To demonstrate that the batch has been sampled in accordance with a sampling plan that ensures a representative sample of the batch is taken.
• To demonstrate that the batch has been analysed using scientifically established tests and methods designed to ensure that the product meets accepted standards and specifications for quality, identity and purity.
• To demonstrate that the batch has stability data to support the intended period of use; these data can be obtained from actual studies on the specific excipient or from applicable "model product" stability studies that can reasonably be expected to simulate the performance of the excipient.