“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.”
Similarly, BIO disagrees with FDA’s proposed alternative approaches for reducing the need for laboratory testing of incoming components and to minimize the need for facilities to have an in-house laboratory.
“We believe that the alternative approach to testing should not be permitted exclusively for outsourcing facilities,” BIO says. “These sites should be accountable for maintaining the same level of control over their contract sites as would any other pharmaceutical manufacturer.””
Read the full article: via Industry groups take issue with guidance on outsourcing facilities.
Go to DREprof.com: The Designated Representative and Exemptee Training Website
- CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. – Available around-the-clock 24 x 7 – Available for iPad
- FL Certified Designated Representative (CDR) online exam prep course by SkillsPlus Intl Inc. – Lots of practice exams – Practice makes perfect! – Available around-the-clock 24 x 7
- The Designated Representative Institute
- CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc. – Enhanced for iPad
- The Exemptee Institute
