Quality/GMPs

Peter Gaskin, PhD, is the senior director of scientific advisory services for Charles River, an AAPS sustaining partner.

Articles

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

The Essential Ingredient in any Sponsor-CRO Partnership: Trust

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Which Batch Size for Validation and Stability Studies?

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection

 Washington Editor, jillwechsler7@gmail.com.

FDA is reviving efforts to establish a Quality Management Maturity program.

FDA Revives Initiative to Identify and Reward Quality Drug Operations 

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL

Sue Marchant is senior vice president of Product at 

Data may be used to improve (or remove) a corrective action/preventive action.

Put a Cap on CAPAs

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Quality Control/Quality Assurance