Facility (21CFR211.42(b)) – When multiple products are packaged in the same facility, contamination can be caused by other products. The use of airlocks, increased ventilation, and air filtration can decrease the risk of cross-contamination (Ventilation, air filtration, air conditioning and cooling 21CFR211.46(c)).
The potential for contamination should be evaluated and suitable methods identified and implemented to minimize the risks to the finished product and the packaging personnel.
For more information, see the Code of Federal Regulations.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
The potential for contamination should be evaluated and suitable methods identified and implemented to minimize the risks to the finished product and the packaging personnel.
For more information, see the Code of Federal Regulations.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
