What must be documented for bulk compounding of parenteral solutions using non-sterile chemicals?

In the context of bulk compounding of parenteral solutions using non-sterile chemicals, extensive end-product testing is crucial for ensuring the safety and efficacy of the final product. Since non-sterile chemicals may not meet the strict sterility standards required for parenteral use, it is essential to perform comprehensive testing on the compounded solution to verify that it meets required specifications, including sterility, potency, and purity.

End-product testing serves as a safeguard against potential contamination and ensures that the compound is safe for administration to patients. This testing could include evaluation of particulate matter, microbial contamination, and chemical stability of the compounded solution. By documenting these tests, the compounding pharmacy establishes a quality control measure that is vital in maintaining patient safety, especially given the risks associated with administering non-sterile compounds intravenously.

The other options do not address the critical aspects of safety and regulatory compliance necessary for the compounding of parenteral solutions. For instance, cost analysis or manufacturer certifications, while important in their own right, do not directly impact the immediate safety of the compounded product. Storage conditions are relevant to the stability of compounding, but they do not substitute for the need for rigorous end-product testing that verifies the integrity and safety of the solution