Quality Systems

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

Articles

Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.


Developing an Effective Contamination Control Strategy

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

Stability Indicating Methods for Aluminum Adsorbed Vaccine Products

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

Best Practices for Studying Stability in Biologics

Marchesini Group’s Compact 12 electronic counter with HarleNIR vision system measures product and active ingredient when filling and capping bottles for tablets and capsules.

Counting Machine with NIR Ensures Quality Control for Solid-Dose Products

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

Data Integrity Violations Found at China Facility

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

India Facility Receives Warning Letter

The company is recalling the product because of potential microbiological contamination.

Pfizer Recalls Two Lots of Relpax

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

New Jersey Facility Receives FDA Warning Letter

Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.

Topical Products Recalled

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Quality risk management plans provide identified actions to 
ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.


Quality Assurance/Quality Control