QA/QC

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | QA/QC

Cellares Launches Cell Q Automated cGMP QC Workcell for Cell Therapies

Aims to resolve manual QC processing bottleneck and extend IDMO capabilities from manufacturing through quality control.

04.18.24

QA/QC | Regulatory Affairs

Do You Know Your Product's Impurity Profile?

Regulatory insights from the experts at Lachman Consultants.

Paul Mason, Executive Director, Lachman Consultants 04.10.24

Analytical Services | Methods Development | QA/QC | Regulatory Affairs

Regulatory Affairs: What is the New FDA Guidance on Q14 Analytical Procedure Development?

Insights from the experts at Lachman Consultants.

Joseph Posada, Consultant, Lachman Consultants 04.05.24

Aseptic Processing | Fill/Finish | Inspections | Parenterals | QA/QC

GRAM: Ensuring Quality Through Vigorous Finished Product Inspections

A Q&A with Brian Korson, director of finishing operations at Grand River Aseptic Manufacturing.

Sponsored released by Grand River Aseptic Manufacturing 03.27.24

Breaking News | Industry News | QA/QC

SGS Lab in Fairfield, NJ Earns ISO/IEC 17025:2017 Certification

Accreditation covers a range of chemical testing and in vitro cytotoxicity testing for finished medical devices, medical device components, drugs and packaging.

03.11.24

Analytical Services | GMPs/GCPs | Laboratory Testing | QA/QC

Never Assume!

Analytical insights from the NIR Professor.

Online Exclusives Emil W. Ciurczak, Contributing Writer 03.04.24

Inspections | QA/QC | Regulatory Affairs

Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report

Issued 170 warning letters and monitored 264 drug recall events during the year.

Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc. 02.01.24

Analytical Services | Bioanalytical Services | Laboratory Testing | QA/QC | Regulatory Affairs

Stability Testing for Drug Products: Ensuring Safety, Efficacy & Regulatory Compliance

Evaluating extractables and leachables, overseeing manufacturing processes, ensuring adherence to CGMPs and comprehensive packaging testing.

Sandi Schaible and Britt Jones, WuXi AppTec 02.01.24

Crystal Formulations Services Passes EU QP Audit

Crystal Pharmatech’s CDMO business unit poised for global growth.

01.31.24

Samsung Selects Rapid Micro for Quality Control Testing

Growth Direct platform to automate microbial quality control processes for increased efficiency, more robust data integrity, and scalable quality control ops.

01.05.24

Breaking News | Industry News | Information Technology | QA/QC

Recipharm to Use Veeva Vault QMS to Harmonize Global Quality Ops

Aims to achieve greater quality oversight, use resources more effectively, accelerate validation, and maintain inspection readiness.

01.03.24

QA/QC

U.S. Pharmaceutical Annual Recalls Set to Reach Highest Number in a Decade

The latest recall data, product safety and regulatory developments, as well as how businesses can protect themselves from risks associated with new regulations.

Online Exclusives Kristin Brooks, Managing Editor, Contract Pharma 12.19.23