Quality Systems

Articles

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

FDA Finds CGMP Violations at Canadian Facility 

Francesca Speroni is project leader at PTM Consulting and is a member of the AFI process validation working group.

Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco and is a member of the AFI process validation working group.

Maurizio Valleri is in Pharmaceutical Technology at Menarini and is a member of the AFI process validation working group.

Mauro Silvestri is in Manufacturing Technology at Angelini and is a member of the AFI process validation working group.

Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing and is a member of the AFI process validation working group.

in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Alessia Garavaglia is in Good Engineering Practices at Grünenthal and is a member of the AFI process validation working group.

 at Mipharm and is a member of the AFI process validation working group.

Rosa Terribile is in QA at Mipharm and she is a member of the AFI process validation working group.

Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific and is a member of the AFI process validation working group.

Enrico Modena is in R&D at PolyCrystalLine and is a member of the AFI process validation working group.

Stefano Selva is in Pharmaceutical Technology at Recordati and is a member of the AFI process validation working group.

Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche and is a member of the AFI process validation working group.

Cesare Armetti is an AFI member and participates in the AFI process validation working group.

 is an AFI member and participates in the AFI process validation working group.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

Enhancing Process Validation for Solid Oral Dosage Forms: Part 2

Agnes Shanley is senior editor of Pharmaceutical Technology.

Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to
compounders.

Ending ‘Magical Thinking’ in Compounding

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.  

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

Norm Howe is senior partner, Validation & Compliance Institute.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

Strong Quality Culture: A How-To for Busy Managers

Editor of Pharmaceutical Technology Europe

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

Unlocking the Key Changes to Annex 1

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

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

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

Writing Effective SOPs

Vanessa Fachada Oliveira, is a pharmacovigilance manager and EU QPPV at Arriello. She is a qualified pharmacist with knowledge of pharmacovigilance (PV) legislation, and extensive experience in PV, Quality Management and Medical Information. Based in Lisbon, Portugal, Vanessa supports clients both as a PV consulting specialist and as a global EU QPPV/deputy QPPV or LPPV for the local territory. Arriello is a global provider of regulatory affairs and pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

Pharmacovigilance Under Scrutiny: Why Companies are Falling Short

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing

Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.

An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel.

Computer Systems Validation–a (Un-)Manageable Task?

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

is head of Solid Form Services at Lonza Pharma & Biotech and was previously 

principal scientist at Capsugel’s Bend, Oregon facility.

Innovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.

Evaluating Drug Substance–Drug Product Interplay Accelerates Development

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

Compounded Heparin Sodium Recalled

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

Data and the Supply Chain

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

FDA Publishes Guidance on Antibacterial and Antifungal Drugs

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Flora J. Keumurian, florak@mit.edu, is program and operations manager, MIT Center for Biomedical Innovation.

Michael E. Wiebe, mewiebe@mit.edu, is lead investigator, CAACB, and principal at Quantum Consulting, MIT Center for Biomedical Innovation.

Jacqueline Wolfrum, jwolfrum@mit.edu, is co-director, Biomanufacturing Program, and director, BioMAN, MIT Center for Biomedical Innovation.

James C. Leung, leungjc@mit.edu, is lead investigator, CAACB, and senior research fellow, MIT Center for Biomedical Innovation.

Anthony J. Sinskey, is faculty director, MIT Center for Biomedical Innovation; Professor of Biology, MIT, asinskey@mit.edu.

Stacy L. Springs, ssprings@mit.edu, is senior director of programs and executive director of Biomanufacturing Initiatives, MIT Center for Biomedical Innovation.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations. 

The Impact of SARS-CoV-2 on Biomanufacturing Operations

The COVID-19 pandemic has raised several questions about the safety of the pharmaceutical materials supply chain. Is onshoring the answer?

Quality Assurance/Quality Control