D2- Medicines Design and manufacturing intro Flashcards
what are specials?
medicines made for patients with special needs which cannot be met by licensed medicines
how do you follow “good working practice”
-ensure medicines produced are of a very high quality: clean environment to avoid contamination and accurate measurements so patient receives correct dose
-ensure procedures are safe for manufacturers: risk assessment and precautions)
what is the batch manufacturing document?
document to prove a medicine has been made correctly- used to keep a permanent record in real life
Describe the main label on medicine
main source of info and allows to track the product down
Describe the ancillary label
warning and advisory label
what is self life?
time over which the medicine remains stable when stored under the recommended conditions in a specific packaging
-medicines produced by hand are always less stable than licensed medicines manufactured in industry
How do you decide on an expiry date?
pharmacists might judge the product to be discarded after a few days or a week because:
-one ingredient is chemically unstable
-formulation is physically unstable
-risk of microbial contamination during use (e.g eye drops, creams packed in jar)
-packaging does not protect the medicine against instabilities
How do you decide on storage conditions? what does it depend on?
-instabilities of the ingredients
-stability of medicine itself
-protection provided by packaging
all medicines should be stored in what kind of place?
cool place
all powders should be stored in what kind of place?
dry place, protection from moisture
storing medicine in a cool place provides protection from what instabilities?
heat, microbiological growth, volatile
storing medicine in a dark place provides protection from what instabilities?
light and oxidation
storing medicine in a dry place provides protection from what?
moisture
storing medicine in a tightly closed container provides protection against what instabilities?
moisture and air
