midterm 1 Flashcards
It importance has been recognized in the pharmaceutical industry.
QUALITY SYSTEMS
It is evident that it is a valuable component of an effective quality system.
QUALITY RISK MANAGEMENT
It is defined as the combination of the probability of occurrence of HARM and the SEVERITY of that harm.
RISK
It is assured based on appropriate risk based DECISION-MAKING throughout the PRODUCT LIFECYCLE, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.
PRODUCT QUALITY
50-200 healthy subjects (usually) or patients who are not expected to benefit from the IMP
PHASE 1 CLINICAL TRIAL
100-400 patients with the target disease
PHASE 2 CLINICAL TRIAL
1000-5000 patients with the target disease
PHASE 3 CLINICAL TRIAL
Many thousands or millions of patients with the target disease
PHASE 4 CLINICAL TRIAL
It is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
QUALITY RISK MANAGEMENT
Zone I
TEMPERATE ZONE
Zone II
MEDITERRANEAN/SUBTROPICAL ZONE
Zone III
HOT DRY ZONE
Zone IVa
HOT HUMID/TROPICAL ZONE
Zone IVb
HOT/HIGHER HUMIDITY
It can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used.
STRESS TESTING OF DRUG SUBSTANCE
It will depend on the individual drug substance and the type of drug product involved.
NATURE OF STRESS TESTING
It is likely to be carried out on a single batch of the drug substance.
STRESS TESTING
It should be an integral part of stress testing.
PHOTOSTABILITY TESTING
Data from formal stability studies should be provided on at least _______ of the drug substance.
THREE PRIMARY BATCHES
The stability testing should cover, as appropriate, the ____, ____, ____, _____ attributes.
PHYSICAL
CHEMICAL
BIOLOGICAL
MICROBIOLOGICAL
____ for a drug substance is defined as failure to meet its specification.
SIGNIFICANT CHANGE
It involves a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture.
ICH STABILITY STUDIES
The long-term testing should be performed over a minimum of ___
12 MONTHS
It is an essential operation in the production of drugs.
It is a procedure or set of procedures designed to ensure the output of uniform batches of drugs conforms to the established specifications.
QUALITY CONTROL OF PHARMACEUTICAL FORMULATIONS