PRELIMS Flashcards
GMP acronym
Good Manufacturing Practice
10 golden rules
- get the facility design right from the start
- validate processes
- write good procedures and follow them
- identify who does what
- keep good records
- train and develop staff
- practice good hygiene
- maintain facilities and equipment
- build quality into the whole product lifecycle
- perform regular audits
‘Sometimes you need to step back and reconsider the whole production area’
Golden Rule #1
Get the facility design right form the start
the aim of Lay out the production area
educe the chances of cross contamination and to avoid mix-ups and errors
don’t have final product passing through or near areas that contain intermediate products or
raw materials
A logical and well-planned layout will improve ____. Do not apply _____.
productivity; quick fix solutions
2 aims of facility area
- remove unnecessary traffic in the production area which could result in a hazardous environment
- segregate materials, products, and their components to minimise confusion and potential for mix-ups and errors.
what rule:
A company failed to keep the product manufacturing process linear. As the product moved through the factory, it was zigzagged from one area to another.
1
highlights of rule 1
- facility layout
- environment
- equipment
whats wrong w the sentence:
- interior surfaces (walls, floors and ceilings) are rough, free from cracks and do not shed particulate matter
- drains are sized adequately and have no trapped gullies
rough (smooth); remove no
how prove that equipment and processes consistently do what they are supposed to do?
testing and documentation is required
he key to maintaining safety and effectiveness of every product and enhances a company’s reputation for quality and reliability.
consistent performance
“Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”
validation
All validation activities should be well planned and clearly defined by means of?
a Validation Master Plan, or VMP
Once this is complete, define the testing and documentation required.
consider all the critical parameters that may be affected and impact product quality
involved in validation
- Installation Qualification, or IQ,
- Operational Qualification, or OQ
- Performance Qualification, or PQ
which is testing to verify that the equipment is installed correctly
IQ
which is testing to verify that the equipment operates correctly
OQ
which is testing to verify that product can be consistently be produced to specification
PQ
highlights of golden rule 2
validation and change control
what should be prepared to complete the testing and provide a written report
A protocol describing each test and the acceptance criteria
Once testing is complete and the equipment or process is known to be controlled, it’s important to maintain its ‘_______’.
validated state
If a change to the validated state is required then it must be subject to
change control
should be in place to document all changes to facilities, equipment, or processes that may have an impact on product quality. You should evaluate the impact of the change and define the extent of re-validation.
a change control system
what rule:
Some years later an auditor discovered that changes had been made to the system. No re-validation work had been performed and the system was no longer in its validated state.
2
Procedures should be
clear, concise, and logical
whats wrong:
Having a dependent party reviewing your procedures also leads to process improvements.
independent