Quality Systems

Videos

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

Technology Introduces a New Normal for Quality Practices

Articles

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

Florida Manufacturer Warned for Inadequate Written Procedures 

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

Excipient Quality and Impact on Formulation

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

Syntegon Validates First AI-Equipped Visual Inspection System in Production Line

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

PathoQuest Joins CAACB Consortium as Viral Safety Expert

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS. 

The Value of Pharmacopeial Reference Standards

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

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

Frequently Asked Questions on Regulatory Inspections

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

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

Protein Characterization Can Support Regulatory Submission

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

Conducting Effective Audits During and Post Pandemic

The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.

Meitheal Pharmaceuticals Recalls Cisatracurium Besylate 

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

Editor of Pharmaceutical Technology Europe

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

The Budding Field of Cannabis Pharmaceuticals

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

Coming Up to ISO IDMP Standards

Feliza Mirasol is the science editor for 

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.

Meeting Specificity Needs for Biologic Drug Substance Testing

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

Florida Company Receives FDA Warning Letter

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

Recall of Paroex Oral Rinse Expanded

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

ISPE Releases First Guide from its Advancing Pharmaceutical Quality Program

Will Kanyi is Senior Training Specialist at Catalent Biologics.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in Mind

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

VMIC Adopts Lonza’s Paperless Quality Control Microbiology Platform

The product is being recalled because of Burkholderia cepecia contamination.

Quality Assurance/Quality Control