Quality Systems

Manuel M. Garza is a principal consultant with PAREXEL Consulting, a subsidiary of PAREXEL International, manuel.garza@parexel.com.

Articles

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

How to Plan Smoke Studies

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

Andrew Walsh, M.S., certified Lean Six Sigma Black Belt, is President of the Center for Pharmaceutical Cleaning Innovation in Hillsborough, NJ. He can be reached at andy.walsh@centerforpharmaceuticalcleaninginnovation.org.

Tomohiro Doi is principal scientist of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Kosuke Takenaka is principal scientist of Biologics & New Modalities Development; Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Takashi Kaminagayoshi is director and head of Manufacturing Operations of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Shunsuke Omori is scientist of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Makoto Sadamitsu is principal scientist of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Yoshiaki Miko is associate director of Biologics & New Modalities Development, Pharmaceutical Sciences at Takeda Pharmaceutical Company Limited.

Osamu Shirokizawa is director and senior consultant of Life Scientia Ltd. 

The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.

The Statistical Evaluation of Cleaning Processes Using Process Capability and its Application to New Product Introduction

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

Data Integrity Failures and Other CGMP Violations Found at China Facility

A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.

Federal Judge Enters Consent Decree With Drug Compounder

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

CDER Publishes Drug Safety Report

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs. 

FDA Publishes Q&A on GMPs for APIs

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

European Pharmacopoeia Commission Sets Quality Requirements for Live Biotherapeutic Products

A new report gives an overview of the work of the International API Inspection Program.

Report Gives Update on International API Inspections

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

Quality Assurance/Quality Control