Regulation of Aseptic Processing in the 21st Century - Pharmaceutical Technology

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Regulation of Aseptic Processing in the 21st Century
The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.


Pharmaceutical Technology
Volume 35, pp. s46-s50

References

1. FDA, Sterile Drug Products Produced by Aseptic Processing (Rockville, MD, Jun. 1987).

2. FDA, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practices (Rockville, MD, Sep. 2004).

3. EMA, Annex 1, Sterile Medicinal Products (London, 2009).

4. Task Force on Sterile Drug Products Produced by Aseptic Processing, (with support from the Japanese Ministry of Health, Labor, and Welfare), Guidance for Industry—Sterile Drug Products Produced by Aseptic Processing, (Tokyo, 2005).

5. J. Agalloco and J. Akers, Pharm. Technol. 30 (7), 60–76 (2006).

6. M. Miller and M. Walsh, PDA Annual Meeting (Las Vegas, 2009).

7. International Standards Organization, Standards 14644-1 to 8: Clean Rooms and Associated Controlled Environments (Geneva, 1999).

8. B. Reinmuller, Building Services Engineering, Bulletin 56, (Royal Institute of Technology, Stockholm, 2001).


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