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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 9 Also, some analytical methods are developed to detect specific impurities and may not be able to detect others, especially when they are not expected to be present. Again, this points to the importance of process control and validation to ensure analytical methods and limits of detection are suitable for their intended use. Presence of mold. Yet another example is mold, which is commonly found in the environment, including pharmaceutical facilities. Production sites and operating procedures must be designed to exclude mold from the product to the extent that this is possible. Absolute control is generally unattainable However, as is the case with other microorgan- isms, absolute cont rol is genera l ly u nat ta in- able. The presence of mold does not mean that a catastrophic conta mination event is immi- nent. Similarly, its absence during monitoring should not be interpreted as proof that mold is not present. Only robust process control and validation; facil- ity and equipment design and qualification; mean- ingful quality systems; and high levels of personnel qualification and training can reliably and consis- tently produce drug products exhibiting the levels of quality, purity, and potency they are intended to possess. Quality cannot be tested in, especially where the parameter being evaluated is zero, none detected, or inappropriate to the analytical method used. Unfortunately, product release ref lects an overemphasis on measured results. In parametric release, the quality attributes must be firmly estab- lished by the process controls and quality systems when the parameters being measured are essen- tially unknown and unknowable. References 1. L.M. Boyd, "This and That: Shy Suffer Hay Fever," Ellensburg Daily Record, p. 8 [Crown Syndicate, Inc.], Ellensburg, Wash- ington. (Google News Archive) 2. Deming, W. E., Out of the Crisis, pp. 20 and 121 (Massachusetts Institute of Technology, Cambridge, Mass., 1986). 3. FDA, 21 CFR 211.22 (c). 4. FDA, 21 CFR 211.165 (e). 5. M. Rees, Project Cyclops: A Design Study of a System for Detect- ing Extraterrestrial Intelligent Life, rev. ed., ed. B. M. Oliver and J. Billingham, 1973. 6. K. Chapman, Pharmaceutical Technology, 15(10), pp. 82-96 (1991). 7. B. Matthews, PDA Journal of Pharmaceutical Science & Tech- nology, 56(3), pp. 137-149 (2002). 8. E. Fry, Presentation at the PDA Annual Meeting., November, 1980. 9. S. Sutton, "The Sterility Tests," Rapid Sterility Testing, Molden- hauer. J., editor, PDA/DHI Publications, pp 7-24, 2011. 10. USP 37, Chapter <71>,Sterility Tests, 2014. 11. J. Akers, J., Agalloco, R. Madsen, Bioprocessing and Sterile Manufacturing 2016, a Pharmaceutical Technology eBook, pp 24-30 (2016). 12. USP-NF <1071>, Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach, 2018. 13. S. Langille, PDA J Pharm Sci and Tech, 67 (3), pp.186-200 (2013). 14. S. Bukofzer, S.; Ayers, J.; et al, PDA J. Pharm. Sci. Technol., 69(1) pp. 123–139 (2015). 15. J.Z. Knapp, J. Z., PDA J. Pharm Sci and Tech, 53(6) pp 291-302, (1999). 16. USP-NF<1>, Injections and Implanted Drug Products (Paren- terals)—Product Quality Tests, 2016. 17. FDA Drug Recalls list, www.fda.gov/Drugs/DrugSafety/Dru- gRecalls/default.htm 18. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 1986. 19. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004. 20. J. Agalloco, Bioprocessing and Sterile Manufacturing 2016, a Pharmaceutical Technology eBook, pp 31-35 (2016). 21. PDA, Technical Report No. 25, "Blend Uniformity Analysis: Val- idation and In-Process Testing," Parenteral Drug Association, Inc., Bethesda, Maryland, 1997. PT Quality cannot be tested in, especially where the parameter being evaluated is zero, none detected, or inappropriate to the analytical method used.