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
what rule: ‘Procedures should be clear, concise, and logical’
3
Documentation requirements
The following documents are typical in the food, drug, and medical device industry:
- specifications
- operating instructions
- operating procedures
- records
These detail the requirements with which products and materials have to conform, i.e. they serve as a basis of quality evaluation
specifications
These detail material and equipment requirements and describe the steps to complete a task
Operating Instructions
These give direction for performing certain tasks and provide higher-level instruction than operating instructions.
Operating Procedures
These provide a history of each batch and provide a mechanism to check that you are following operating procedures and instructions.
records
a useful tool in writing good prcoedures
flowchart
Writing good procedures
Break the procedure into chunks and use:
headings
tables
bullet points
diagrams.
whats wrong:
When writing procedures try to visualise the person that will use it. Use language they will understand and don’t include too much or too little information.
none
whats wrong:
You can increase the readability of your procedures by using simple sentences and by writing in a formal style.
formal (conversational)
what’s a usability test
Print out two copies of the procedure and ask someone unfamiliar with the task to follow it. Mark up the second copy with notes about where they found the document confusing. This will highlight problems with the document and is a great learning experience for the writer.
Most companies have a___-year review cycle for their documents
3
what rule:
Some operators resist following procedures because they think they have a ‘better’ way of working.
3
Introduce a “_____” system within the work group where the team meets to discuss procedures that are not followed. Allow operators to suggest how they think a task should be performed and act on it
Better Operating Procedures
2 reasons not to take a shortcut in following procedures
Many shortcuts may create pitfalls that can be costly in the end. Each step in a procedure has been included for a purpose.
what rule:
Identify who does what
All employees should clearly understand what they have to do each day. It avoids misunderstandings and minimises the risk to product quality. You should create a job description for each role to define:
job title
job objective
duties and responsibilities skill requirements.
4
Some areas that are vulnerable to overlap include:
cleaning
validation
calibration.
what rule
During a validation batch a series of samples were not taken as the operators thought that validation staff would take them, whilst validation thought that the operators would take them. The sampling responsibilities should have been detailed in sampling procedures and the validation documentation.
4
‘If it’s not written down then it didn’t happen!’
golden rule 5
enable you to track all activities performed during batch manufacture from the receipt of raw materials, to the final product release; they provide a history of the batch and its distribution.
good records
what rule:
Companies need people who know how to the job right first time, every time’
6
highlights of train and develop staff
training, demonstrating job competence,
what rule:
To convince staff of the importance of washing their hands after toileting, ask the microbiology department to take fingerprint samples from each operator after they have washed their hands. They can then see how much bacteria is present on their ‘clean’ hands.
7
what rule
Walk around your plant and check all the calibration stickers you can see. If they are out of date then your maintenance process is not being controlled properly
8
prevents equipment breakdowns, which can be costly. It also reduces the risk of product contamination and maintains the ‘validated state’ of the facility or equipment.
regular equipment maintenance
highlights of golden rule 9
controlling components
controlling the manufacturing process
packaging and labelling controls
holding and distribution controls
must be conducted to assess whether you are following the GMP rules.
audits
who conducts audits
External bodies such as the Food and Drug Administration (FDA) or the Therapeutic Goods Association (TGA)
system to manage and fix anything found during an audit.
Corrective Action Preventative Action (CAPA
self audit checklist highlights
written procedures job competence docu and validation sanitation and cleanliness maintenance of the workplace quality control
common but complex practice, process of exchanging messages between people
interpersonal communication
core characteristics of an empathetic healthcare professional
understanding the perspectives of patients, communicating effectively, working from people from other disciplines
intercom model
- sender
- message
- receiver
- feedback
- barriers
who transmits the message
sender
selection of words, symbols, etc.
encoding
element that is transmitted
message
method mode of comm (phone, email, ftf)
channel
interpretation of what we just heard
decoding
interference
barriers
response of the message
feedback (positive and nega)
4 types of barriers
physical, psychological, physiological, semantic
