Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems
The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.


Pharmaceutical Technology
Volume 33, Issue 1, pp. 72-80

Toyohiko Takeda, PhD,* is chief of the good manufacturing practice committee, and Hiroshi Hirasawa is chief of the package subcommittee, both at the Japan Society of Pharmaceutical Machinery and Engineering, Miyoshi Bldg. 3F, 2-7-3, Kandata-cho, Chiyoda-ku, Tokyo, 101-0046, Japan, tel. +81 3 3252 3048, fax +81 3 3252 3049,

*To whom all correspondence should be addressed.

Submitted: June 22, 2008. Accepted: July 8, 2008.




What would you do differently? Email your thoughts about this paper to
and we may post them to the site.

References

1. ICH, ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Geneva, Nov. 10, 2000).

2. International Society for Pharmaceutical Engineering, "Commissioning and Qualification Baseline Guide" (ISPE, Tampa, FL, vol.5, 2001).

3. The Federation of Pharmaceutical Manufacturers' Associations of Japan, Qualification Practices of the Systems for Solid Dosage Forms for Internal Use—The Case of Pan Coating Systems (Japan Society of Pharmaceutical Machinery and Engineering, Tokyo, 2003).

4. The Federation of Pharmaceutical Manufacturers' Associations of Japan, Qualification Practices of the Systems for Solid Dosage Forms for Internal Use—The Cases of Blister Filling/Packaging Systems and Pillow Packaging Systems (Japan Society of Pharmaceutical Machinery and Engineering, Tokyo, 2007).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here