Quality Systems

Feliza Mirasol is the science editor for 

Articles

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

CGT Catapult and CATTI Establish Shared Training Standards for Advanced Therapies

Alan M. Mancini, RPh, is a pharmaceutical scientist.

Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy.

Varanya Chaiyaperm, RPh, PharmD is clinical assistant professor, University of Illinois College of Pharmacy.

An ordered process describing calculations activities for compounded dosage forms is described.

Pharmaceutical Compounding Calculations in a Workplace Environment

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India, at Merck Life Sciences Pvt, Ltd.

K. Vasantakumar Pai, PhD , is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University

K. Sreedhara Ranganath Pai, PhD, is professor, epartment of Pharmacology, Manipal Academy of Higher Education

Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC, at Merck Life Sciences Pvt, Ltd.

Somasundaram Gopalakrishnan, is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd.

Tathagata Ray is Area Manager, Process Development at Millipore India Pvt. Ltd (India).

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

EMA Recommends Eight Medicines for Approval in April

Videos

Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.

Interpreting Regulations and Meeting FDA Requirements at CPHI North America

is quality unit lead and technical director, Bristol Myers Squibb, São Paulo, Brazil.

is director CMC Technical Advocacy and Policy, Merck Sharp and Dohme, LLC, Horsham, PA, USA.

is chief pharmaceutical officer, Sanofi Vaccines, Lyon, France.

is quality assurance director, Merck & Co. Inc., Rahway, NJ, USA.

is scientific director, Johnson & Johnson Innovative Medicine, Leiden, The Netherlands.

is head of External Affairs Europe, Amgen (Europe) GmbH, Rotkreuz, Switzerland.

is global SME Quality Advocacy, Vaccines Global Quality, GSK, Wavre, Belgium.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.



New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

CDER Releases Office of New Drugs 2023 Annual Report

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

Regulatory Oversight