Small Scale Manufacturing - Tim Sizer Flashcards
Why are personalised/bespoke medicines so beneficial to patients?
As it is more specific to the patient and their disease, so clincal outcomes are greater…with less side effects
Especially for those that have very different genetics for certain drugs (eg, fast/slow metabolisers)
What are the 3 conditions that must be met for an unlicenced drug to be used?
In reponse to a bona fide unsolicited order
Formulated in accoradance with the specification of a doctor, dentist of supplementary prescriber
For use by individual patients with the prescribers responsibility
The unlicenced medication must also have data to suggest it is safe and effective….and that any licenced drug in inappropriate
Who takes reponsibility for the formulation of a ‘Special’?
The pharmacist!! Not the manufacturer
What part of the Medicines Act 1968 allows pharmacists to undertake extemporaneous dispensing?
Section 10 exemption
As long as it occurs in a registered pharmacy and under the supervision of a pharmacist
What’s the difference between ISO 9000 and ICH Q10?
ISO 9000 –> A management system to direct and control an organisation with regard to quality
- Focusses on continuous improvement
ICH Q10 –> A combination of GMP and ISO 9000, with key objectives and enablers
- Focus on a product life cycler approach
What is Good Manufacturing Practice (GMP)?
Part of Pharmaceutical quality assurance (QA) which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and the product specification
Concerns both production and quality control
Define Quality
In the pharmaceutical sense
The degree of fitness for purpose
What is Quality Control?
The part of GMP that is concerned with sampling, specifications and testing
Must be done to ensure the product is of good enough quality to be released
What are the 5 possible limitations of PQS?
Cost of quality –> Is it fit for purpose?
Documentation –> Can be overcomplicated
Processess –> Can be too complex (to ensure you meet regulations)
Detail –> May be in excess or be insufficient
Knowledge Management –> Not enough people may understand the reasoning behind the PQS
What are the 6 sources of contamination in an aseptics suite?
People
Workspace
Starting materials and consumables
Storage
Aseptic process
Adminstation of the product
How should cleaning and disinfecting be done in a clean room?
Use a disinfectant rota –> To prevent resistance build up
Use in-use dilution disinfectants (must be used right away) in grade A/B areas
They must also be sterile disinfectants in grade A/B areas
At what temperature should starting materials (in a clean room) be stored at?
2-8 degrees when appropriate
In step 1 of transfer disinfection, what type of disinfectant would be used?
An alcohol spray CONTAINING a sporacide
What are the alert and action levels of contamination for all tests?
Alert –> 2.5% outside
Action –> 5% outside
Why would a special or unlicenced medication be used?
If a licenced product doesnt exist, or is no longer avaliable
What can special manufactures advertise?
Their service!
Not the drugs that they can make (products)
Price lists can however be published after an ammendment in the Medicines for Human Use Regulations 2010
What should risk assessments be specific to?
Individual pharmacy
Staff working in the pharmacy
Each medicine to be made
How long does the HMR 2012 require people, selling or supplying an unlicenced medication, to maintain and keep the documentation of supply?
5 years
What is the TSE guideline?
Transmissible Spongiform Encephalopathies (TSE) regulations
No unlicenced medication can be supplied/imported unless it has been made in accordance with the TSE guidlines
If any product is found to contain TSE or cause harm as a result then it is the manufactuers that are held liable
What do manufactuers of unlicensed medications create to try and prevent being liable for issues?
SOPs and policies to show that they are doing things correctly
What are 5 ways that we can control risk in manufacturing?
Verification (of clinical need)
Quarantine on receipt (to prevent supply prior to approval)
Inspection (against any specification)
Certificate of conformity/analysis
Formal recorded approval
What is Good Distribution Practise (GDP)?
Part of quality assurance that ensures that products are consistently stored, transported and handled appropriately under suitable conditions
Why are bathrooms and kitchens generally a bad place to keep medication?
Temperature cycling
Moisture
Heat
What are the 6 risks to pharmaceutical drug quality?
Manufacture
Microbiological
Biological (eg, pest control)
Chemical
Temperature
Malicious Intent (human things done on purpose to harm)
Name 5 cold chain products that cannot be frozen
Vaccines
Insulin
PN
Biotech medicines
Blood products
What is the law around pharmaceutical fridges?
Between 2-8 degrees C (blood = 2-6)
Must have a calibrated electronic themometer with a max/min
Must be able to read temeperature from the outside
Must be lockable, and linked to an alarm system
When can the Arrhenius Equation be used to see if a drug can be kept (or should be thrown out) after undergoing thermal stress?
For room temeprature drugs only!
Not fridge lines
What is the aim of the Falisified Medicines Directive (FMD)?
Verify/authenticate medicines at the point of dispensing
What types of medicines are likely to be counterfeit?
High value lifestyle drugs (eg, viagra)
High value lines
High volume, mid priced drugs (eg, Lipitor)
