Potency definition
Examples of Potency in a sentence
Deviations shall be categorized as Major (determined to have potential to adversely impact the Safety, Quality, Identity, Potency, or Purity of the Products or compliance with regulatory filings regarding the Products, and subject to formal investigation and resolution according to WuXi procedures) or Minor (determined to have no adverse impact as described above).
Potency tests commonly used for LBPs assess the product viability, for example in terms of viable CFUs per dose.
Send required samples of eradicated illicit cannabis to the National Institute on Drug Abuse (NIDA) Potency Monitoring Project.
Stock Recovery The removal or correction of a non-marketed Drug Product used in a clinical trial for reasons related to product Safety, Quality, Identity, Potency, or Purity, that has not left the direct control of WuXi.
Complaint (Product complaint) Potency, Purity, Strength Any written, electronic or verbal communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a drug, its labeling or packaging, or device after release for distribution.
Sources of PAHs were assumed to be creosote and to be conservative, the calculated Benzo[a]pyrene Total Potency Equivalents (B[a]P TPE) concentrations for the soil samples were multiplied by an uncertainty factor of three as stipulated in the Guidelines.
Potency of GED.0032: 95 - 105% Content uniformity of GED.0032: rel.
Major Deviation A Deviation incurred during the manufacture, labeling, packaging, testing, storage or shipment of the Products, which on preliminary evaluation is determined to have the potential to impact the Safety, Quality, Identity, Potency, or Purity of the Product, or regulatory commitments/submissions involving the Products.
Nonconformance Deviations incurred during the manufacture, labeling, packaging, testing, storage or shipment of the Product, which AMGEN determined to have the potential to impact the Safety, Quality, Identity, Potency, or Purity of the Product, upon preliminary evaluation and required performing an investigation according to AMGEN SOPs. OOS Result An examination, measurement or test result that does not conform with pre-established specification requirements established by the relevant Party.
A change which materially modifies the regulatory filing for the Product or is determined by Material Change ZMC and/or WuXi to have significant potential to materially affect the Safety, Quality, Identity, Potency, or Purity of the Product.