spacer
home > pmps > summer 2008 > testing for launch
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Testing for Launch

The FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, addresses the review and evaluation of packaging requirements. According to this document, each new drug application (NDA) or abbreviated new drug application (ANDA) should contain enough information to demonstrate that a proposed container closure system and its components are suitable for its intended use.

The type and extent of information required will depend on the dosage form and route of administration. Qualification and quality review is applied to packaging materials and to the actual dosage form. Packaging suitability is based on four attributes: protection, safety, compatibility and performance (function and/ or drug delivery). For injectable dosage forms, the document outlines the tests required to show that interaction is not a problem.

Associated components, such as those used only at the time a dosage is administered, self-adhesive labels and secondary packaging materials are also included in the review process. Inhalation and injection drug products have to meet the highest requirements. There are product-specific draft guidelines for metered dose inhalers (MDI), dry powder inhalers (DPI), nasal sprays and inhalation solutions, suspensions and spray drug products. The identity and concentration of leachables in inhalation and nasal drug products must be monitored throughout the dosage form’s shelf life since the product consists of the dosage form and container closure system.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Frances L DeGrazio has been with West since 1983. Throughout her tenure she has served in various roles with the analytical laboratory and research and development areas. She is a member of the Parenteral Drug Association (PDA), American Chemical Society (ACS) and the American Association of Pharmaceutical Scientists (AAPS). Fran holds a BS degree in Chemistry from Cabrini College in Radnor, Pennsylvania, US.
spacer
Frances L DeGrazio
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Distributor Oppurtunities

Have an appetite for success – Want to expand your product portfolio – Fancy being part of something special??
More info >>

White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement