Quality Systems

A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

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

Initiatives to speed drug development must pass Congress and special interest groups.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

As CMOs shed their old toll processing role, sponsors can expect the right questions, proactive communication, and a firm grasp of risk management and tech transfer from contract service providers.

CPhI experts make predictions on pharma trends for 2015.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

Experts review considerations for selecting excipients for solid-dosage drug performance and manufacturability.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

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

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

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.”

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

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

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.

The FDA center released a list of the guidance documents it plans to publish in 2015.