21 CFR 110, 210 and 211: Current Good Manufacturing Practice – Human Foods, Drugs, and Pharmaceuticals

Compliance with FDA and other regulations is a serious matter. While most companies are conscientious and proactive in compliance, many want some level of “comfort” that cGMP compliance practices are up to par. Discovering and addressing a deficiency before an FDA or a customer visit is preferable to the alternative. That’s where McAllister can help.

We offer an array of customized services to help you achieve and maintain compliance, while helping to identify and capture efficiencies that are more visible to an outsider. Typically, we provide an internal audit to the targeted CFR and render an internal audit report. The nature of this audit and report are aligned with the organization’s objectives – addressing a previous or suspected nonconformance, meeting a specific customer requirement for third party auditing, or simply developing a new source of input for improvement and effectiveness.

McAllister Consulting is management’s eyes and hears…….and provides an independent voice to assist management in making and implementing compliance decisions.