Quality & Compliance

Two of the most vital aspects of the regulatory profession, Quality & Compliance examines the ins and outs of achieving both while still keeping other factors in mind for a successful regulatory experience.

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7 August 2012

Comparing Drug Master File Procedures in Highly Regulated Markets

By S.K. Sahu, MPharm, PhD, and P.K. Nandi, MPharm

Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Read More...

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Canada

DMF

drug

Drug Master File

EMA

FDA

India

pharmaceutical
Categories: category

Quality and Compliance

6 August 2012

Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

By Alexander Gaffney

The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exhibited by medical device and pharmaceutical manufacturers. Read More...

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compliance

drug

Injunction

medical device

pharmaceutical

warning letters
Categories: category

Quality and Compliance

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Quality & Compliance

Comparing Drug Master File Procedures in Highly Regulated Markets

Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

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