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

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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.




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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).


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