Quality Systems

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Visual inspection of parenteral vials is the first step in a root cause investigation.

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The company is voluntarily recalling one lot of product due to a potential packaging mistake.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

FDA issued a warning letter to College Pharmacy for multiple violations.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

The Chinese facility was cited for data integrity violations.

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.