PDA Task Force Issues Guidelines to Aid Isolator Users

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2002
Volume 26
Issue 3

When FDA reviewed PDA's Technical Report No. 34 about isolator systems, significant differences of opinion between the organizations came to light.

External Link - article-12150.pdf

Articles in this issue
Outsourcing Outlook
Developing Custom Adhesive Systems for Transdermal Drug Delivery
Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II
PDA Task Force Issues Guidelines to Aid Isolator Users
Recent Advances in Semisolid Dosage Forms for Dermatological Application
Drug Safety Concerns Shape Manufacturing Policy
Production Information Mangement
Functionality Testing of a Multifunctional Directly Compressible Adjuvant Containing Lactose, Polyvinylpyrrolidone, and Croscarmellose Sodium
Public CROs Craft New Strategies to Achieve Financial and Strategic Objectives
Validation Changes to the USP Assay Method for Ibuprofen Tablets
Systematic Troubleshooting for LC/MS/MS
Product Development Issues of Powders for Injection
Oral Low Molecular Weight Heparin Absorption From Solution and Solid Dosage Forms in Rat, Dog, and Monkey Models
Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Recent Videos
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Young man having asthma attack or choking suffering from respiration problems | Image Credit: © Feodora - stock.adobe.com

UK Anaphylaxis Nasal Spray Approval Helps Reshape Emergency Allergy Treatment

Christopher Cole
July 18th 2025
Article

Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

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

EMA Moves to Secure Supply of Critical Drugs Used During Pregnancy

Susan Haigney
July 10th 2025
Article

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

medicine and vision concept - woman closeup and eye diagram, future technologies | Image Credit: ©Julia - stock.adobe.com

Advanced Solutions for Sustained Delivery of Ocular Therapies

Cynthia A. Challener
July 4th 2025
Article

Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Susan Haigney
July 2nd 2025
Article

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.