good manufacturing process Flashcards
what’s less precise? small scale manufacture or large scale manufacture?
small scale manufacture
why is small scale manufacture less precise?
no licensed product available, product discontinued, individualised dose required, individualised formulation required
what are the reference sources for standard formulas?
the British pharmacopoeia and the pharmaceutical codex
do all products have standard methods and formula?
no, not all products
what do you do when a product doesn’t have a standard method and formula?
use a similar method, Consider the physical and chemical properties of the components
what are some of the things checked in quality control?
- equipment is suitable and in working order
- formula and dose of product is safe and correct
- all raw materials are sourced appropriately
- calculations are correct
- detailed records are kept
- labelling requirements are met
- staff involved area adequately trained
is record keeping a legal requirement? how long must they be kept for?
yes, minimum of 2 years, max 5
what do the records include?
formula & source, checked calculations, checked ingredients (manufacturer, quantities, batch number and expiry), Names and signatures of all people involved in the preparation of the product
, date prepared, expiry date and batch number, date supplied, patient details, doctor’s details, label
what is stability determined by?
physical appearance (if it looks the same), chemical (ingredients have not changed chemically), microbial (sterile vs limited growth), therapeutic effect (not changed), toxicology (no increase in toxic effects)
how are expiry dates determined in large scale and in extemp dispensing?
- in large scale - it’s determined by accelerated stability testing
- in extemp dispensing, determined by the monograph. if not available give the shortest possible expiry date
what do preservatives do?
prevent bacterial growth
what are the 2 most common preservatives in aqueous liquids?
chloroform spirit and chloroform water
