Pharmaceutical Quality System

qa

the planned and systemic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.

qa

the responsibility of an organisation to determine that systems, facilities, and written procedures are adequate and followed in order to assure that products are controlled and will meet all applicable specification.

qc

the observation techniques and activities used to fulfill requirements for quality.

qc

day to day control of quality within a company for the approval or rejection of completed dosage forms.

assurance

it is the act of giving confidence
the state of being certain
the act of making certain

control

it is an evaluation to indicate needed corrective responses
the act of guiding a process in which variability is attributable to a constant system of chance variables.

qa

ensures quality in the processes

qa

focused on prevention

qa

process oriented

qc

ensures quality in the product

qc

focused on defect identification

qc

product oriented

contamination

__ of a starting material/product by another material/product must be avoided.

dust gases vapours sprays organisms

the risk of accidental cross-contamination arises from the uncontrolled release of: (DGVSO)

production in segregated areas

providing appropriate airlocks and air extraction

minimizing recirculation or untreated air

keeping protective clothing

using cleaning and decontamination procedures

using closed systems

testing for residues and using cleaning status labels

cross-contamination should be avoided by appropriate technical or organisational measures like: (seven)

periodically

measures to prevent cross-contamination and their effectiveness should be checked ___ according to set procedures.

line clearance

it is an effective way of preventing possible contamination and mixup of packaging materials

glp

it is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, archived, and reported.

usa 1970s

where and when did the formal concept of glp first evolve?

preclinical safety data

new drug applications

the formal concept of glp first evolved in the usa (1970s) because of concerns about the validity of ___________ ______ ____ submitted to the fda in the context of ___ ____ ____________

gmp

(gmp or glp)
its primary purpose is of product quality and safety

gmp

(gmp or glp)
it applies to manufacturing

glp

(gmp or glp)
its primary purpose is of data quality and study reliability

glp

(gmp or glp)
it applies to preclinical r&d

oecd who

2 references for glp

organisation for economic cooperation and development

oecd stands for?

oecd

it is a unique forum where the governments of 30 democracies address the economic, social, and environmental challenges of globalisation.