Good manufacturing process Flashcards
What does large scale manufacture entail?
It takes place in industry which is a controlled environment. It requires precise manufacture, quality and control testing, large scale equipment, sterile and non sterile conditions and packaging to ensure stability.
Licensed products only.
Mass produced so no consideration to individual patient needs.
What does small scale manufacture entail?
This is in a pharmacy by extemp. Its less precise and so its only used if there’s no alternative. You would do this when the patient needs a non licensed product or if the product is discontinued, individual dose/formulation required.
What is specials manufacturing?
This is for companies that make bespoke products or for toxic/complex preparations. There is a high cost incurred for the individual though and so the NHS are trying to reduce the costs of this type of manufacturing.
Hospital extemp can be sterile or non sterile, what kind of products are made for each?
Sterile: TPN, drugs requiring reconstitution
Non sterile: manufacturing bespoke products
Are pharmacists allowed to dispense unlicensed products? Who said this?
Yes they are, the GPhC
What are the two reference sources used when making products?
- The British Pharmocopeia
2. The pharmaceutical codex
What quality control factors need to be taken into consideration?
- equipment must be in working order
- all raw materials must be sourced appropriately
- detailed records must be kept for a minimum of 2yrs by law
- staff must be adequately trained
What method do you use to mix unequal quantities of solids?
increasing quantities method
What properties determines stability?
physical appearance, chemically the ingredients should be the same, therapeutic effect shouldn’t have changed, no increase in toxicity
What are the general expiry dates for stable and non stable preparations?
Stable: 3 months
Unstable: 4 weeks
How is the expiry date for large scale manufactured products determined?
Through accelerated stability testing
