|Large or small, new or old, warehouses storing |
pharmaceuticals must comply with FDA regulations.
An Ode to 21 CFR Part
211 Subpart H
by Laurie Meehan
Social Media Manager
Polaris Compliance Consultants, Inc.
Storing stuff doesn’t sound like it should be difficult, but complying with FDA’s detailed regulations for warehousing pharmaceuticals can be. To start, your warehouse has to be clean and pest-free. Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering. Your facility also needs proper drainage, ventilation, adequate space, and work lighting. (Is your warehouse susceptible to flooding? Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?) You also have to make sure your product is not exposed to more heat, cold, humidity, or light than stability testing recommends. (Do you have moisture and temperature sensors throughout? Is the heat tunnel you use for sealing shrink wrap too hot? Do you have backup refrigeration? Have all of these devices been cleaned, serviced, inspected, and calibrated?) And what are your procedures if you find any safety threshold has been exceeded? Are your people adequately trained?
This article is related to the Whitepaper: 21 CFR Part 11 Industry Overview - Ready for an FDA Inspection? To get the full details, please download your free copy.
Meeting these strict requirements takes a lot of work, and if you do it right, it’s something to sing about. And here’s the song to sing!
Courtesy of Polaris Compliance Consultants, Inc.
Is your warehouse a pit of despair or a shining example of regulatory control? Tell us about it!
Ms. Meehan is the Social Media Manager for Polaris Compliance Consultants, Inc. She writes the company blog and eNewsletter, manages the company website, interacts with clients and colleagues on social media platforms, and manages the company’s SOPs and internal training. Prior to joining Polaris in 2008, Ms. Meehan worked at a major telecommunication R&D company where she provided consulting and training on telecom services, and spoke at numerous industry forums. She holds a BA in Computer Science from La Salle University and an MS in Computer Science from Drexel University.