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Pharmaceutical products
*prevention *treatment *diagnosis components/ingredients GMP *safety *efficacy *quality stable acceptable
Spoilage
deterioration
* physical property
* chemical property
RATE OF DETERIORATION
Depends on:
Molecular structure of the chemical Physico-chemical property of a particular environment Type and quantity of microbes Availability of metabolites for use as another energy source = more synthesis and multiplication
Organoleptic
Smell (unpleasant/sickly) Taste (sour, fishy, bad eggs, bitter, earthy, sickly) Color (pigmented) Viscosity/consistency/texture (thickening, less viscous, slimy, creaming, cracking) Sedimentation of suspended ingredients Gaseous metabolites (visible bubbles)
*Hospital
IN USE *Human
*Environmental
In manufacture
Outbreaks of infection
In use
Home use: less often to be contaminated but contains lower /fewer organisms when used in small quantities Depends on storage conditions
PRESERVATION OF MEDICINES USING ANTIMICROBIAL AGENTS Minimizes risk of contamination Kills low levels of contaminants introduced during storage or repeated use Usually non-selective in action May cause hypersensitivity reactions Consider factors that influence anti-microbial activity
Concentration: varies depending on agent used Temperature: varies depending on agent used Preservatives are used up as they inactivate contaminating organisms
QMS
Effective QAP in
Examples: Preservative challenge test (D-value) GMP (manufacture, control of ingredients, plant construction, process validation, production and cleaning) Bioburden assay Pyrogen testing (Limulus test) Toxin detection Test for signs of physico-chemical spoilage Post-market surveillance