Thursday, January 16, 2014

What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:
  • GMP - good manufacturing practice, or
  • CGMPR (current good manufacturing practices regulations)
If you're unfamiliar with the FDA cGMPs, then consider taking this online course:

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Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
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Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
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Monday, January 13, 2014

Access Designated Representative Training - SkillsPlusInc.com

English: iPad 2 with Smart Cover running iMovie.
English: iPad 2 with Smart Cover running iMovie. (Photo credit: Wikipedia)
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Don’t Skip The DQSA Definition of Terms Section - RxTrace

Follow the link below, and heed Dirk Rodgers/RxTrace advice. Here's a sampling of glossary terms that might interest you:  dispenser, distribution, exclusive distributor, repackager, 3PL provider, wholesale distributor.

Don’t Skip The DQSA Definition of Terms Section - RxTrace:

"Section 581, Definitions, is a special glossary of terms whose definitions only apply within the text of the law.  So if you read the other sections and you assume the dictionary or the everyday definition of certain terms, you will miss the full meaning of those sections."

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Wednesday, January 8, 2014

Exemptee Training - California

English: iPads offer a variety of software
English: iPads offer a variety of software (Photo credit: Wikipedia)
Exemptee Training - California

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Monday, January 6, 2014

Home Medical Equipment Market Report 2012 - 2018 - SBWire

Home Medical Equipment Market Report 2012 - 2018 | Jan 6, 2014 - SBWire:

"It is estimated that the U.S. will be the largest market for home medical equipments owing to its wide base of home healthcare equipment providers, good reimbursement policies, better healthcare infrastructure and high healthcare expenditure. Moreover, the recent changes in the healthcare industry due to ‘Obamacare’ will also boost the demand for such equipment, since almost 30 million uninsured Americans will now enjoy medical coverage."

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