Personnel, Premises And Equipment Flashcards
(59 cards)
The MOST IMPORTANT ASSET in the manufacturing company are
Why?
People
Oversee the process
The CORRECT manufacture of medicinal product relies upon
People
Where the RELATIONSHIPS between the heads of production, quality control and where APPLICABLE head of quality assurance and the POSITION of qualified person’s are clearly shown
Organizational chart
People in positions should have _______________ recorded in WRITTEN JOB DESCRIPTIONS and _______________ to carry out responsibilities
Specific duties
Adequate authority
There should be no _______________ in the responsibilities of personnel concerned
No gaps or unexplained overlaps
To know WHERE TO REPORT
Hierarchy
The MANUFACTURER should provide TRAINING for all the personnel whose duties take them into
Production
Storage
Control laboratories
NEWLY RECRUITED should receive
Training appropriate to the duties assigned
Personnel working in areas where ______________ should be given specific training
Contamination is a hazard
They should NOT BE TAKEN into the PRODUCTION and QC areas
Visitors
Untrained personnel
Personnel hygiene
All personnel should receive _______________ upon recruitment
Medical examination
No person affected by an _______________ or having _______________ on the exposed surface of the body is engaged in the manufacture of medicinal products.
Infectious disease
Open lesions
Personnel should wear _______________ appropriate to the operations to be carried out
Protective garments
Most COMMON SOURCE of contamination
Skin
What department wears LABORATORY GOWN ONLY
QC
R&D
Where should eating, drinking, chewing or smoking or it’s storage should be PROHIBITED
Production
Storage
DIRECT CONTACT should be avoided between
Operators hand
Product
Equipment
Personnel should be INSTRUCTED to use what facility
Hand-washing facility
Premises and equipment must be _______________ to suit the operations to be carried out
Located
Designed
Constructed
Adapted
Maintained
Used to CALCULATE building system equipment CAPACITIES and aid in the SELECTION of appropriate types of equipment
Design parameter
Organization consistent with the level of NONVIABLE and VIABLE particulate contamination
Cleanliness classification
Largely determines the CLASS OF CLEANLINESS that can be maintained during a given operation
Air change rate
NON-UNIDIRECTIONAL FLOW clean rooms rely on ____________ to continuously remove contaminants
Air dilution
General ceiling
More effective in continuously sweeping particles from the air due to the PISTON EFFECT created by the uniform air velocity
Unidirectional flow
