Development

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy. 

Pharma 4.0

Agnes Shanley is senior editor of Pharmaceutical Technology.

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

Innopharma Bets on Manufacturing 4.0

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Evaluating Surface Cleanliness Using a Risk-Based Approach

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.

A Revised Aseptic Risk Assessment and Mitigation Methodology

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.

Reinventing Lean Six Sigma for the Pharmaceutical Industry

Six years after the guidance, it’s time to change our quality assurance vocabulary.

Process Validation: Do We Need Brainwashing?

Thomas Peglow is senior cleaning validation expert at Novartis Pharma AG, Switzerland. 

The industry needs a single standard cleaning limit at 25 mg/m2.


Cleaning Validation for APIs

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 author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.


Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

James Jardine is a marketing content specialist for MasterControl.

Walt Murray, ICLA, CSSMBB, president and CEO of ARC Experts and strategic partner for MasterControl Quality & Compliance Consulting, is a globally recognized compliance and risk consultant.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations. 

Avoiding Investigational Failure/Discrepancy-Related Form 483 Observations

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.