The quality control and testing for CSPs in this chapter are appropriate and necessary.
The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.
ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry.
Our laboratory works with pharmaceutical companies, compounding and hospital pharmacies, drug manufacturers, and raw material suppliers bringing excellence to pharmaceutical sciences.
Services Offered: ARL provides full laboratory services for pharmaceutical and biotechnology companies.
Laboratory services include testing for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), medical devices (510K) and over-the-counter products.
Testing the concentration of the drug is just one component of a stability study.
Testing should include evaluation of the physical, chemical, and microbiological properties of the product.ARL Bio Pharma provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities, and health-system pharmacies.Our laboratory partners with industry suppliers bringing excellence to the compounding industry.A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and p H; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed.Compounding supervisors shall ensure through either direct measurement or appropriate information sources that specific CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% if not specified, until their beyond-use dates.