Investigation of Out-of-Specification Results

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-01-02-2002
Volume 26
Issue 1

The authors summarize the results of the September 2000 PhRMA workshop discussions about conducting out-of-specification investigations.

External Link - article-6989.pdf

Articles in this issue
What Does Pharmacy Automation Mean for Packaging?
Novel Acrylate Adhesives for Transdermal Drug Delivery
Optimal Tablet Press Operation: Machine versus Granulation
Manufacturers Face Shifting Priorities in the New Year
Investigation of Out-of-Specification Results
Reaping the Benefits of E-Procurement
Outsourcing Outlook
Recent Videos
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Data technology background. Abstract background. Connecting dots and lines on dark background. 3D rendering. 4k. | Image Credit: © Dmitry

Emerson Unveils AI Platform for Mission-Critical Industrial Applications

Christopher Cole
May 22nd 2025
Article

Emerson’s purpose-built industrial AI solutions are meant to enhance accessibility and reliability, enabling manufacturers to maximize efficiency and performance from automation systems.

Site Logo

Transformations in Drug Development for Cell and Gene Therapies

PPD;Thermo Fisher Scientific
March 28th 2025
Podcast

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

·Mirai Bio and Thermo Fisher are partnering to integrate design, delivery, and CGMP manufacturing for nucleic acid-based therapeutics. ·The collaboration will leverage Thermo Fisher’s RNA and advanced formulations facility to support scalable development of genetic medicines. ·Mirai’s machine intelligence platform will be combined with Thermo Fisher’s technical and manufacturing expertise to streamline drug development workflows.

Mirai Bio and Thermo Fisher Partner to Advance Genetic Medicine Manufacturing

Christopher Cole
May 21st 2025
Article

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.

Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang

Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang

PPD;Thermo Fisher Scientific
March 28th 2025
Podcast

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Abnormal plasma cell or b-cell in multiple myeloma emitting paraprotein 3d illustration | Image Credit: © LASZLO - stock.adobe.com

CellCentric Completes $120 Million Series C Funding Round for Multiple Myeloma Treatment Inobrodib

Patrick Lavery
May 21st 2025
Article

Inobrodib is being developed as a first-in-class oral cancer drug that the company says will be able to treat not only multiple myeloma, but other specific cancers as well.

A group of antibiotic pill capsules falling. Healthcare and medical 3D illustration background | Image Credit: © James Thew - stock.adobe.com

Personalised Capsule Machine Unveiled by ACG

Christopher Cole
May 20th 2025
Article

ACG partnered with Art of You to launch the world-first Personalised Capsule Machine, enabling on-demand, customized supplement capsules based on individual health data.