Biomedical Engineering Reference
In-Depth Information
7. 21 CFR 211.56, Sanitation.
8. 21 CFR 211.25, Personnel qualifi cations.
9. See Paul Pluta (2009).
10. See Richard Forsyth (2009).
4.6 References
Avellanet, J. (2008) Lean compliance for midsized companies.
J. GXP Comp.
12(2), 30-5.
Colligon, I., Rosa, M. (2007) GLP SOPs for equipment
calibration and maintenance, Part 4: Logistics of SOP
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Qual. Assur. J.
, 11, 60-3.
DiLollo, J. (2000) The use of SOPs in a pharmaceutical
manufacturing environment.
J. cGMP Comp.
4(3), 33-5.
Forsyth, R. (2009) Visual cleanliness, in P.L. Pluta (ed.),
Cleaning and Cleaning Validation
, PDA/DHI Publishing,
Bethesda, MD, vol. I, pp. 293-337.
Moldenhauer, J. (2009) Microbial and endotoxin residues -
product-contact surfaces, in P.L. Pluta (ed.),
Cleaning and
Cleaning Validation
, PDA/DHI Publishing, Bethesda,
MD, vol. I, pp. 177-81.
Pluta, P.L. (2009) Personnel training - visual inspection of
cleaned equipment, in P.L. Pluta (ed.),
Cleaning and
Cleaning Validation
, PDA/DHI Publishing, Bethesda,
MD, vol. I, pp. 350.
Porter, D. (2010) Standard operating systems viewed as
dynamic networks.
PMF News.
16(12), 2-9.
Rosa, M. (2006) GLP SOPs for equipment calibration and
maintenance, Part 1: An overview.
Qual. Assur. J.
10(2),
107-10.
