Regulatory/GMP Compliance

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

New guidance complements ICH guidelines on impurities.

FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Pharma can boast of big-picture successes, but needs to work on operational issues.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

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.