Quality/GMPs

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Articles

Clear understanding of what exactly the biomolecule entails is essential.

Using Protein Characterization to Support Regulatory Submissions

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

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 collaboration addresses the need for risk mitigation plans in cell therapies.

Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress. 

Technology’s Role in QA/QC

Art Meisler is principal consultant at Daelight

Successful migrations require careful planning to meet business needs and maintain data integrity.

How To Execute Successful Data Migrations

Feliza Mirasol is the science editor for 

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Single-Use Sensors Increase Process Understanding

Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Complex Manufacturing Processes Prompt New Inspection Methods

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Complex Modalities Require More Sensitive Adventitious Agent Testing

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

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

Resuming Operations During a Pandemic

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

Margaret M. Faul is vice-president, Drug Product Technologies, Process Development, Amgen.

Carl L. McMillian is vice-president, Toxicology, Drug Disposition, PK/PD, Eli Lilly and Company.

Pierre Boulas is executive director, Product and Technology Development, Biogen.

Reginaldo A. Saraceno is director, Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals.

Mary Devlin Capizzi is partner, Faegre Drinker Biddle & Reath LLP.

Maureen T. Cruz is senior manager, Science, Regulation and Policy, Faegre Drinker Biddle & Reath LLP.

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

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Chase Waller works in quality, both at AbbVie Inc.(North Chicago, IL).

Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

Zahid Muhammad works in quality at Merck & Co., Inc. (West Point, PA).

John Bennett works in quality at Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT).

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software. 

Assessing Data Integrity Risks in an R&D Environment 

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

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

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19. 

FDA’s “Gold Standard” Critical for Biopharma R&D

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

Quality Control/Quality Assurance