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
Behind the Headlines, Episode 10
Jens Schmidt, associate director MSAT at Lonza
Related Content
Movement towards the intended goal. Moving forward, step by step. Labor and aspiration. Motivation, self-development. Business strategic planning, risk management. New opportunities. Achieve. | Image Credit: ©Andrii Yalanskyi – Stock.Adobe.com

Steps to Process Development Optimization

Susan Haigney
February 4th 2025
Article

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

Drug Solutions Podcast: Forecasting Pharma’s Future

Drug Solutions Podcast: Forecasting Pharma’s Future

Felicity Thomas
January 31st 2025
Podcast

This episode is a compilation of comments taken from a series of interviews where experts reveal the trends that have impacted the bio/pharma industry in 2024 and those they expect to be impactful in 2025.

3d rendering of Antibody drug conjugates (ADCs) are targeted medicines that deliver chemotherapy agents to cancer cells | Image Credit: © Love Employee - © Love Employee- stock.adobe.com

Advancing ADCs to the Next Level

Feliza Mirasol
February 4th 2025
Article

CDMOs who have integrated technologies can help further the advancement of ADC development.

Drug Solutions Podcast: Realizing AI’s Potential

Drug Solutions Podcast: Realizing AI’s Potential

Felicity Thomas
December 20th 2024
Podcast

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

Alvogen Recalls Fentanyl Transdermal System

Susan Haigney
February 3rd 2025
Article

The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

EMA Recommends Eight New Medicines for Approval in January

Patrick Lavery
February 2nd 2025
Article

Another eight medications already authorized in the EU were recommended for extensions of various indications.