английский => русский Медицина Медицина: Фармацевтика

The finding / defect has potential or specific influence on the product which thereby becomes potentially life-threatening or may cause heavy damage to health.
The finding / defect has potential or specific influence on the product and does not fall in category 1.
This finding / defect has no perceptible impact on the product (the proper quality of which has been proved).
It is proved that it does not present any significant risk and cannot be classified as critical (1) or major (2).
a. Service Provider “Technical Review Committee as part of Pfizer Global Environment, Health and Safety” (TRC), and “Genetic Toxicology Center of Emphasis (GTOX CoE) as part of Pfizer World Wide Research and Development, Research & Development Drug Safety” (GTOX)
a. In part, clear statements concerning the presence / absence of the risks genotoxicity, reproductive or developmental toxicity, carcinogeneity, and high potential of sensitization are missing (Examples:
In both cases, repair orders were commissioned on 05 Jul 2016 while the inspection was still ongoing:
Quality Operations / Rooms and Equipment Computerized System MSB (My Signature Book)