Article archive

GMP and Quality, Responsibility, Integrity, and Accountability - Article

15/08/2013 03:07
GMP and Quality, Responsibility, Integrity, and Accountability This article describes how to instill these important character traits into your people to assure commitment to GMP

Wooden's Pyramid of Success - John Wooden's Pyramid of Success

15/08/2013 02:52
Wooden's Pyramid of Success - John Wooden's Pyramid of Success   A good article which is useful for personal growth....

New Draft Guidance - Cosmetic Good Manufacturing Practices

15/08/2013 02:49
New Draft Guidance - Cosmetic Good Manufacturing Practices - Updated draft aligns GMP with ISO 22716:2007

Roche to invest $105M into training center

15/08/2013 02:44
While many companies are scaling back production operations around the world, Roche has seen its logistics and packaging operations in Switzerland grow by about 500 employees in recent years. To keep up with the need for trained employees for the operation, Roche says it will invest $105 million to...

FDA’s Special Agents: Criminal Investigators

15/08/2013 02:35
  FDA’s Special Agents are part of FDA’s Office of Criminal Investigation. Learn more about them here – https://1.usa.gov/151pdJ1  

FDA issues Guidance for Industry on Risk-Based Monitoring

15/08/2013 02:01
FDA issues Guidance for Industry on Risk-Based Monitoring This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and...

New Stimuli Article on Method Development, Performance Qualification and Performance Verification

15/08/2013 01:59
  The members of the USP Validation and Verification Expert Panel have published a Stimuli article on lifecycle management of analytical procedures. In the article entitled "Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure...

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

15/08/2013 01:54
FDA Releases Guidance on Quality Agreements for Contract Manufacturing The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” This guidance describes FDA's current thinking...

Sun Pharma to pay Rs 2517 crore to settle patent suit

15/08/2013 01:45
Sun Pharma to pay Rs 2517 crore to settle patent suit Indian Express Drug firm Sun Pharmaceutical Industries has said it will pay its dues of Rs 2,517.41 crore soon as part of settlement agreement with Wyeth (now a division of Pfizer Inc.) and Altana Pharma AG (now known as Takeda GmbH). "We have a...

PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

15/08/2013 01:40
Applicants expecting an approval for their product for the American market are usually striving to receive an import permit for the still-unapproved drug from the FDA. This way they want to be prepared for the day when the approval letter arrives to be able to serve the American market without...
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