Do Plant Isolates Have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is It a Matter of Science versus Compliance?

References

1. 1.↵
   U.S. Food and Drug Administration. Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories. FDA Web site. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/microbiological-pharmaceutical-quality-control-labs-793 (accessed January 15, 2022).
2. 2.↵
   U.S. Food and Drug Administration. Pharmaceutical Microbiology Manual, Revision 2. FDA Web site. https://www.fda.gov/media/88801/download (accessed January 15, 2022).
3. 3.↵
   U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004. https://www.fda.gov/media/71026/download (accessed January 15, 2022).
4. 4.↵
   European Commission. EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1: Chapter 6—Quality Control. European Commission: Brussels, 2014. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-11_vol4_chapter_6.pdf (accessed January 15, 2022).
5. 5.↵
   Pharmaceutical 1Inspection Convention/Cooperation Scheme (PIC/S), Document PI 012-3: Recommendation on Sterility Testing. PIC/S: Geneva, 2007. https://www.gmp-compliance.org/files/guidemgr/PI%20012-3%20Recommendation%20on%20Sterility%20Testing.pdf (accessed March 23, 2021).
6. 6.↵
   1. Cundell T.,
   2. Massaro C.,
   3. Tidswell E. C.

   Live, Stressed, and Dead Microorganisms—Their Role in Microbial Test Method Validation. Am. Pharm. Rev. 2021, 24 (2), 26–32.

   OpenUrl
7. 7.↵
   1. Liu B.,
   2. Eydallin G.,
   3. Maharjan R. P.,
   4. Feng L.,
   5. Wang L.,
   6. Ferenci T.

   Natural Escherichia coli Isolates Rapidly Acquire Genetic Changes upon Laboratory Domestication. Microbiology 2017, 163 (1), 22–30.

   OpenUrlCrossRef
8. 8.↵
   1. Bachmann H.,
   2. Starrenburg M. J. C.,
   3. Molenaar D.,
   4. Kleerebezem M.,
   5. van Hylckama Vlieg J. E. T.

   Microbial Domestication Signatures of Lactococcus lactis Can Be Reproduced by Experimental Evolution. Genome Res. 2012, 22 (1), 115–124.

   OpenUrlAbstract/FREE Full Text
9. 9.↵
   1. Sutton S.

   Quality Control of Microbiolo-gical Culture Media. PMF Newsletter. http://microbiologynetwork.com/quality_control_of_microbiological_culture_media.asp (accessed January 15, 2022).
10. 10.↵
    1. Krisher K.

    The Quality Control of Microbiological Media Revisited: Is It Time for a Change? Clin. Microbiol. Newsl. 1999, 21 (20), 161–162.

    OpenUrl
11. 11.↵
    1. Nagel J. G.,
    2. Kunz L. J.

    Needless Retesting of Quality-Assured, Commercially Prepared Culture Media. Appl. Microbiol. 1973, 26 (1), 31–37.

    OpenUrlPubMed
12. 12.↵
    1. Westney R.

    The Use of In-House Microbial Isolates in Media Growth Promotion Testing: Challenges and Solutions. Amer. Pharm. Rev. 2021, 24 (4), 36–39.

    OpenUrl
13. 13.↵
    1. Sandle T.

    The Human Microbiome and the Implications for Cleanroom Control. Eur. J. Parenter. Pharm. Sci. 2018, 23 (3), 89–98.

    OpenUrl
14. 14.↵
    1. Cundell A. M.

    Microbial Ecology of the Human Skin. Microb. Ecol. 2018, 76 (1), 113–120.

    OpenUrl
15. 15.↵
    1. Cherif A.,
    2. Ettoumi B.,
    3. Raddadi N.,
    4. Daffonchio D.,
    5. Boudabous A.

    Genomic Diversity and Relationship of Bacillus thuringiensis and Bacillus cereus by multi-REP-PCR Fingerprinting. Can. J. Microbiol. 2007, 53 (3), 343–350.

    OpenUrlPubMed
16. 16.↵
    1. Torbeck L.,
    2. Raccasi D.,
    3. Guilfoyle D.,
    4. Friedman R.,
    5. Hussong D.

    Burkholderia cepacia: This Decision is Overdue. PDA J. Pharm. Sci. Technol. 2011, 65 (5), 535–543.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    1. Sutton S.,
    2. Jiminez L.

    A Review of Reported Recalls Involving Microbiological Control 2004-2011with Emphasis on FDA Considerations of “Objectionable Organisms”. Amer. Pharm. Rev. 2012, 15, 42–57.

    OpenUrl
18. 18.↵
    1. Sandle T.,
    2. Vijayakumar R.

    Cleanroom Microflora. In Cleanroom Microbiology; PDA/DIH: Bethesda, MD, 2014; pp 141–188, Chapter 6.
19. 19.↵
    1. Panch S. R.,
    2. Bikkani T.,
    3. Vargas V.,
    4. Procter J.,
    5. Atkins J. W.,
    6. Guptill V.,
    7. Frank K. M.,
    8. Lau A. F.,
    9. Stroncek D. F.

    Prospective Evaluation of a Practical Guideline for Managing Positive Sterility Test Results in Cell Therapy Products. Biol. Blood Marrow Transplant. 2019, 25 (1), 172–178.

    OpenUrl
20. 20.↵
    1. Mahmood A.,
    2. Ali S.

    Microbial and Viral Contamination of Animal and Stem Cell Cultures: Common Contaminants, Detection, and Elimination. J. Stem Cell Res. Ther. 2017, 2 (5), 1–8.

    OpenUrl