O`zbekiston respublikasi sog`liqni saqlash vazirligi toshkent farmasevtika instituti

Operational Qualification (OQ):
The documented verification that the 
facilities, systems and equipment, as installed or modified, perform as intended 
throughout the anticipated operating ranges. 
55.
Overage :
Increased content of drug substance, usually due to loss of potency 
on storage.
56.
Performance Qualification (PQ): 
The documented verification that the 
facilities, systems and equipment, as connected together, can perform effectively 
and reproducibly, based on the approved process method and product specification. 
57.
Pharmacopoea:
Pharmacopoeia is a book or encyclopedia of Drugs 
Standards, their formulas, Methods for making medicinal preparations and other 
related information's which is published under the jurisdiction of government body. 
58.
Placebo:
A product which stimulates the marketable product but has no 
active ingredient present. 

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59.
Process Validation: 
The documented evidence that the process, operated 
within established parameters, can 
60.
perform effectively and reproducibly to produce a medicinal product meeting 
its predetermined specifications and quality attributes. 
61.
Qualification:
Action of proving and documenting that equipment or 
ancillary systems are properly installed, work correctly, and actually lead to the 
expected results. Qualification is part of validation, but the individual qualification 
steps alone do not constitute process validation. 
62.
Qualification Threshold
: A limit above (>) which an impurity should be 
qualified. 
63.
Quality Risk Management
: A systematic process for the assessment, 
control, communication, and review of risks to the quality of the drug product across 
the product lifecycle. 
64.