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Original Article Reference: raps.org | Regulatory News | 07 March 2023 |  By Joanne S. Eglovitch Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). Higgins outlined some of the consequences that can occur when these variables are not controlled, including warning letters or Form 483 reports, and discussed some inspection trends and common...

What Does OOS Mean? The Out-Of-Specification (OOS) process is an adjunct to microbiology testing at a contract research laboratory. For compounders, this can include research and development USP testing (e.g. potency, container closure), ISO 11137 irradiation sterilization validations, and compendial USP release testing (e.g.potency, sterility, endotoxin). The OOS process involves thoroughly investigating the results against defined parameters to ascertain whether the root cause is derived from the sample submission, the laboratory testing process (e.g. equipment, media), and/or personnel. The first step in the OOS process is investigating the root cause(s). Every testing facility has its own system of handling OOS...

Packaging selection is critical when developing compounded sterile parenteral products. The primary packaging system must be compatible with the product formulation, maintain sterility, and be convenient for use by patients or medical administrators. Packaging selection for parenteral products must also consider the product’s intended use. For example, single-dose injectables may require primary packaging with smaller volumes to prevent wastage, while multi-dose products may require larger volume primary packaging to accommodate multiple doses. In addition to compatibility and convenience, the packaging system must have appropriate seal strength and integrity to protect against microbial contamination. Every compounder is required to have completed...

When an FDA-approved sterile ophthalmic drug from a licensed manufacturer is unavailable, pharmacists are asked to prepare sterile drug products intended for ophthalmic administration. Additionally, ophthalmologists have articulated the opportunity for compounders to combine multiple drug prescriptions into a combined commercially compounded product. In both instances, the medical practitioner sites opportunity for increased patient compliance and procedural outcome. Sometimes these sterile drug products are administered topically, in solutions, suspensions, or ointments, and other times they are administered through subconjunctival or intraocular (e.g. intravitreal and intracameral) injection. The most crucial factor in either situation is the sterility assurance level of the...