QUALITY
•
what is quality?
• why
is quality important?
• how do we ensure quality
products?
GOOD
MANUFACTURING PRACTICE
• A
brief history of GMP
• the big picture
• who checks our standards?
• the aim of this teaching
THE
BASIC REQUIREMENTS OF GMP
APPROPRIATELY
QUALIFIED AND TRAINED PERSONNEL
PERSONAL
HYGIENE AND PROTECTIVE CLOTHING
APPROVED
RAW MATERIALS AND CONTAINERS AND THEIR
CORRECT STORAGE
• materials
management
• purchasing, receiving, storage, dispensing
APPROVED
PROCEDURES AND INSTRUCTIONS
• how does the company decide on the best
procedures to make
their products?
• How can production be sure they are using
the correct starting
materials?
• How can production staff avoid mix-ups and
contamination, keep
company costs low and ensure
quality products?
• producing contamination
free products
REPROCESSING/REWORK
QUALITY
CONTROL
• quality control
laboratories
• operator's responsibility
• quality assurance's responsibility
SAMPLING
TESTING
DOCUMENTATION
PACKAGING
GMP
AUDITS
