FDA Releases Guidance on Vial Fill Size - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Releases Guidance on Vial Fill Size


FDA has released guidance that clarifies the agency’s current thinking on allowable excess volume and labeled vial-fill size in injectable drug and biological products. The draft guidance document states FDA’s requirements and recommendations in regards to allowable excess volume in vials. The guidance also explains when justification is needed for a proposed excess volume in these injectable drug products.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) point out the importance of appropriate packaging sizes for injectable drug products in the guidance. The agencies recommend that labeled vial fill sizes be appropriate for the intended use and dosing of the drug product.

Fill and packaging issues for injectable drug products that are packaged in vials and ampules, including products that require reconstitution, are addressed in the guidance. Injectable drug products in other packaging types (e.g., prefilled syringe package systems and intravenous infusion bags) or noninjectable products are not covered in the guidance because there may be unique considerations for these packaging configurations. FDA states that the guidance applies to new drug applications, abbreviated new drug applications, biologics license applications, and new packaging supplements to these existing applications submitted to CDER and CBER.

Source: FDA.gov

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here