Risk Management, cGMP, and the Evolution of Aseptic Processing Technology

References

1. 1.↵
   Code of Federal Regulations, 21 CFR 210—Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General, Part 211—Current Good Manufacturing Practice For Finished Pharmaceuticals, 1976.
2. 2.↵
   International Conference on Harmonization, Q8, Pharmaceutical Development, 2006.
3. 3.↵
   International Conference on Harmonization, ICH, Q9, Quality Risk Management, 2006.
4. 4.↵
   International Conference on Harmonization, Q10, Pharmaceutical Quality System, 2007.
5. 5.↵
   FDA. Draft Guidance for Industry, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, 2004.
6. 6.↵
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   2. Gordon B.

   Current practices in the use of media fills in the validation of aseptic processing. J. Parenter. Sci. Technol. 1987, 41 ( 4), 128– 141.

   OpenUrlPubMed
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   1. Agalloco J.,
   2. Akers J.

   Current practices in the validation of aseptic processing—1992. PDA Technical Report #17. J. Parenter. Sci. Technol. 1993, 47 ( Supplement 1), S1– S21.

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   1. Agalloco J.,
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   Current practices in the validation of aseptic processing—1996. PDA Technical Report #24. PDA J. Pharm. Sci. Technol. 1997, 51 ( 2), supplement.
9. 9.↵
   1. Agalloco J.,
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   3. Madsen R.

   Current practices in the validation of aseptic processing—2001. PDA Technical Report #36. PDA J. Pharm. Sci. Technol. 2002, 56 ( 3).