Quality Systems

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

Articles

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

Improve Automation, but Beware of the Pitfalls

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Determining Comparability of Biosimilars Through Statistical Approaches

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements. 

FDA Offers Guidance on How to Include Bioequivalence Info in ANDAs

KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.

Atovaquone Oral Suspension Recalled

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

FDA Issues Warning Letter to Syntec Pharma Corp

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

Grouping Products and Equipment for a Worst-Case Cleaning Validation Study

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.

A Digital Supply Chain Helps Ensure API Quality

Simone Cossari is a PhD student (University of Turin), simone.cossari@external.merckgroup.com

Aloisio is data integrity specialist at RBM S.p.A, Ivrea, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.

Valerio Capirone is engineering and technology specialist at RBM S.p.A, Ivrea, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.

Raffaele Lasala is quality auditor at RBM S.p.A, Ivrea, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.

Stefano Simonato is automation specialist at RBM S.p.A, Ivrea, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.

Consider how to apply ALCOA+ to a building management system in non-clinical laboratories.

Implementing Data Integrity Compliance in a GLP Test Facility

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Cliff Mitchell works in Analytical Research and Development at AbbVle Inc.

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Koottala S. Ramaswamy works in Global Development Quality at Merck & Co., Inc.

Thomas Purdue is quality analyst V, Boehringer Ingelheim.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Quality Assurance/Quality Control