IC12 Quality Assurance & Pharmacopeial Assays Flashcards
What are the 5 components of Good Manufacturing Practice (GMP)?
- Starting materials must be pure
- Premises & equipment must be maintained
- Have competent people
- Use latest technology & science
- Documentation of manufacturing process
What is the international organisation that monitors the quality of medicines?
The International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human Use (ICH)
What are the 4 tests that ICH helps to standardize?
- Identification tests
- Quantitative tests for impurities
- Limits tests for impurities control
- Quantitative test for APO, drug ingredients & selected components in the drug
List some examples of sources of impurities
- Raw materials
- Manufacturing methods
- Atmosphere contaminants
- Manufacturing hazards - e.g cross-contamination, packing errors, microbial contamination, particulate contamination
- Inadequate storage - e.g temperature effects, filth
What is a limit test and what is it used for?
Limit tests are semi-quantitative or quantitative tests.
Limit tests help to identify & control small quantities of impurity that may be present in the drug.
What is the comparison method in a limit test?
The comparison test involves:
- A standard - containing a definite amount of impurity
- The drug that is being tested
Both the standard and drug that is being tested for impurities are tested at the same time and the results are then compared.
What are the things that we can conduct limit tests on?
- Limits of insoluble matters
- Limits of soluble matters
- Limits of moisture, volatile matters, & residual solvents
- Limits of non-volatile matter
- Limits of residue on ignition - Use of total ash method
- Precipitation methods
Total ash method - is a measure of the total ash remaining after incineration. High ash value is an indication of contamination and impurities.
What are the 3 identification tests in the USP that we learnt about?
- Infrared absorption
- UV absorption
- Thin Layer Chromatographic Identification Test (TLC)
How does Infrared absorption test work?
Infrared absorption shows the peak and troughs which correlates with the functional group of the compound.
How does UV absorption test work?
UV absorption test involve the use of a standard and a the test solution and compare the differences in peak and trough.
How does Thin Layer Chromatography (TLC) work?
A test solution and standard solution are used in TLC. Both solutions are split into its constituents and compared.
Titrimetric analysis is a testing method that uses titration.
What are the advantages and disadvantages of titration?
Advantages:
- Can be very precise and accurate
- Generally robust - able to withstand adverse condition
- Process can be automated
Disadvantages:
- Method may not be selective
- Time consuming
- Large amount of sample and reagents required
