The reasons of this observations are discussed below;
The firm did not calibrate or verify the accuracy of the temperature-controlled function of the equipment to ensure the manufacturing process is controlled for each batch.
The firm failed to calibrate or qualify the scale they used to weigh drug components.
The reasons of these observations are discussed below;
The firm did not prepare adequate master and batch production records for the drug product.
The batch records lacked:
• Approval signatures in conformance to a master batch record
• Detailed manufacturing instructions
• Identity of equipment used
• Sampling information
• Yield
The firm made several changes to the manufacturing process without justification or change control.
Without adequate batch records, one cannot assure the uniformity of the drug products from batch to batch.
The reasons of these observations are discussed below;
The firm failed to ensure that all personnel are qualified for the CGMP operations they perform.
For example, the co-owner stated that he is the sole proprietor of the formulation, had full knowledge of the process, and performed all manufacturing operations. However, there was a lack of evidence that the co-owner has the adequate experience to perform these functions nor has received the appropriate CGMP training.
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