Regulatory Oversight

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Cleanability is crucial when choosing components for GMP manufacturing areas.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency releases five draft guidance documents related to drug compounding and repackaging.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.