319 - Making Medicines For Pharmacy Flashcards
What is the medicines act?
Governs the control of medicines for human use and for veterinary use, which includes the manufacture and supply of medicines.
What is the Orange Guide?
- rules and guidance for pharmaceutical manufacturers and distributors
- EU guides to good manufacturing practice and good distribution practice
- EU directives on manufacturing, wholesale distribution and good manufacturing practice
- code of practice for qualified persons and guidance for responsible persons
- standard provisions for manufacturers licenses
- standard provisions for wholesale dealers licenses
- guidance on reporting defective medicines
- voluntary inspections for good (research) clinical practice and manufacturing of active pharmaceutical ingredients
What does CLP stand for?
CLP is classification, labelling and packaging.
What is CLP?
The CLP regulation is an EU regulation which aligns the EU system of classification, labelling and packaging of chemical substances and mixtures to those globally.
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What does COSHH stand for?
Control of Substances Hazardous to Health (2002)
What are the responsibilities set out in COSHH?
- states requirements imposed on employers to protect employees and other persons from the hazards of substances used at work by risk assessment, control of exposure, health surveillance and incident planning
- There are also duties on employees to take care of their own exposure to hazardous substances
What does GMP stand for?
GMP is good manufacturing practice.
What are the aspects of GMP?
- GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. (people, premises, processes, products and procedures)
- These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use
- it is Quality control - process of sampling, testing and comparing results with pre-agreed specifications as part of the overall quality assurance (QA) process
What is QA? (acronym)
QA is quality assurance
What does QA of the aseptic process include?
- validation of
- equipment
- processes
- techniques
- staff involved in preparation
- control of processes by use of
- SOPs
- monitoring
- training
- competency assessment
- supervision
- sel-inspection
- change control
When is validation used in the aseptic process?
Validation is used when a new aseptic unit is commissioned, new equipment, new processes, new techniques, new staff
What is the purpose of validation as part of quality assurance in the aseptic process?
Validation shows that under simulated conditions, aseptic products can be consistently prepared to the required quality. (ie broth tests)
How should spillages be dealt with?
- dealt with immediately
- other staff should be made aware and minimise the number of people in the area
- spill should be cordoned off
- SOP - follow it
- spill kit should be readily available
- if it involves liquid - use an absorbent cloth
- if it involves powder - use a damp cloth
- all contaminated substances/surfaces should be washed down with copious amounts of water
- report it
What are the key points of fire safety?
- mandatory fire training
- different alarms
- small fires - put out, if trained
- assembly point
- keep fire doors shut
- keep fire exits clear
- know where extinguishers are
- follow SOP
- hit fire alarm if find fire
What is the difference in expiry date for a licensed and unlicensed manufacturing unit?
- unlicensed - maximum of 7 days
- licensed - stability data to back up expiry
What are the differences between licensed and unlicensed production units making batches?
- unlicensed - yes small (expiry 1 week)
- licensed - yes, large (stability data)
What are the differences between licensed and unlicensed production units in dispensing from a prescription?
- unlicensed - making for a patient with prescription
- licensed - can make whatever, whenever
What are the differences between licensed and unlicensed units for the supply of products?
- unlicensed - only make products for themselves, cannot be supplied outside
- licensed - can sell ‘outside’
What is a dispensing error?
A dispensing error is a deviation in the dispensed preparation from the prescribed order.
What are possible causes of errors?
- distractions
- transcription errors
- incompetency/lack of training
- checking error/worksheet
- not following SOPs
- time constraints
How does quality assurance reduce errors?
- understanding GMP
- understanding validation procedures
- correct training & training manuals
- SOPs - for everything
- auditable
How do risk assessments reduce errors?
- identify risk/harm to patient/employee and impact of that
- will identify process and should give outcome (risk score)
How does quality control (QC) reduce errors?
- analytical testing
- checking products to make sure they have the correct formulation
- monitor validation
- check SOPs
- perform audits
What does training do to reduce errors?
- rigorous and continuous training
- complete validations
- follow SOPs
- training manual
What is a clinical trial?
A clinical trial is a testing of a new medicine or medical device to evaluate whether it is safe and effective for people to use.
What are the aims of a clinical trial?
- safety
- side effects
- better than current treatment options
- help people feel better
Who regulates clinical trials?
Run in accordance with European legislation and government bodies (MHRA)
What is the role of the MHRA in clinical trials?
- assess and process applications from companies to conduct clinical trials
- provide clinical trial authorisations
What is the role of the qualified person in clinical trials?
- named on license
- responsible for overseeing the overall production process
- products - fit for use (GMP)
- responsible for releasing products
What is an example of a grade A clean room area?
An isolator is an example of a grade A clean room area.
What activities might be undertaken in a grade A clean room area?
- sterile products
- infusions
- eye drops
- TPN
- cytos
- mabs
What PPE should be worn in a grade A clean room area?
- mob cap
- gown/boiler suit + hood
- boots/overshoes/clogs
- gloves
- mask
What is an example of a grade B clean room area?
The room the isolator is in is a grade B clean room area.
What activities are undertaken in a grade B clean room area?
- sterile products
- infusions
- eye drops
- TPN
- cytos
- mabs
(same as grade A)
What PPE should be worn in a grade B clean room area?
- mob cap
- gown/boiler suit + hood
- boots/overshoes/clogs
- gloves
- mask
(same as grade A)
What is an example of a grade C clean room area?
The background environment for isolators is an example of a grade C area.
What activities are undertaken in a grade C clean room area?
- sterile products
- infusions
- eye drops
- TPN
- cytos
- mabs
- non-sterile manufacturing specials
What PPE should be worn in a grade C clean room area?
- mob cap
- gown/boiler suit + hood
- boots/overshoes/clogs
- gloves
- mask
What is an example of a grade D clean room area?
The support room is an example of a grade D clean room area
What is made in a grade D clean room area?
- non-sterile products
- specials manufacture
What PPE should be worn in a grade D clean room area?
gloves & aprons
What personal hygiene requiements are there in a pharmacy production unit?
- no makeup
- no jewellery
- no eating
- no drinking
- no smoking
- no chewing gum
- shower daily
- clean uniforms
- exfoliate regularly
What are the stages of the handwashing technique?
- palm to palm
- right palm over left dorsum with fingers interlaced, and vice versa
- palm to palm with fingers interlaced
- backs of fingers to opposing palm with fingers interlocked
- rotational rubbing of right thumb clasped over left palm and vice versa
- rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa
- wrists are rubbed
How should you wear a mob cap?
Tuck hair in. One also used for beard.
What are the features of a gown in a clean room?
A gown is single weave with a collar (do it up).
Gowns are anti-shedding and anti-static.
What are the features of clogs for clean room clothing?
Clogs are anti-static and have a non-porous sole. Clogs are thick enough to protect the wearer (in case of broken glass) and are waterproof.
What are the features of the gloves used in the clean room?
Gloves are powder-free as powder has microbes. They are impermeable to hand oil and should make a good seal around the wrist.
What technique should be used to don gloves in the aseptic room?
The non-touch technique should be used to don gloves.
What are the two main types of contamination?
- particulate contamination
- microbial contamination
Where does microbial contamination come from?
- water
- raw materials
- personnel
- equipment
What are the consequences of microbial contamination on medicinal products?
- spoilage - product is unfit for use if the microorganism uses the product as a growth medium
- transmission of disease to the user - microorganism may induce disease to the user of the product without producing spoilage
How is the introduction of microbial contamination via water controlled in pharmacy?
- use suitable types of water in pharmacy and pharmacy production
Which type of raw materials are often heavily contaminated with microorganisms?
plant or animal extracs or minerals such as talc
How can equipment be a source of microbial contamination?
The cleaning fluid for the equipment could become contaminated.
Inadequate cleaning may also leave residues of cleaning product which may act as a growth medium.
What are the two main types of particulate contamination?
- instrinsic contamination
- extrinsic contamination
What is intrinsic particulate contamination?
Intrinsic particulate contamination comes from the raw materials and packaging components used in the production of pharmaceutical products.
What is extrinsic particulate contamination?
Extrinsic particulate contamination is generated mainly from environmental contaminants, processing equipment and operators.
What are different microbial and physical testing methods?
- settle plates
- contact plates
- swabs
- finger dabs
- active air sampling
- airflow counts
- hand washing technique
What are the consequences of contamination in manufactured products?
- patient suffers
- product contaminated
- counts higher than orange guide states
Why might there be bacteria in productions?
- poor hand washing
- didn’t use no-touch/aseptic technique
- isolator filters aren’t working properly
Why might there be high particle counts?
- HEPA filter not working
Why might there be growth on settle plates?
- not cleaning isolator properly
- plates not sterilised properly
Why might there be growth on contact plates?
- insufficient cleaning
- operator technique