Study Set Content:
interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity
Range
expresses the precision under the same operating conditions over a short interval of time
Repeatability
expresses the precision between laboratories
Reproducibility
Lab, pilot, small scale and commercial scale studies to establish process
Stage 1 Process Design:
- Facility, utilities and equipment
- Performance Qualification
Stage 2 Process Performance Qualification (PPQ)
- Monitor, collect information, assess during commercialization
- Maintenance, continuous verification, process improvement
- Requires Statistical Quality Control criteria for appropriate acceptance or rejection levels
- Stage 3 Continued Process Verification (CPV):
Two elements:
- Design of the facility and qualification of the equipment and utilities
- Process Performance Qualification confirming the commercial process design
- Products manufactured during this stage, if acceptable, can be released under certain situations.
Stage 2 Process Performance Qualification (PPQ):
- The goal of this stage is to design a process:
- Suitable for routine commercial manufacturing that can consistently deliver a product that meets its critical quality attributes
- Important to understand the degree to which models represent the commercial process
- Control of the process through operational limits and in-process monitoring is essential
Stage 1 Process Design:
is to continually assure that the process remains in a state of control (the validated state) during commercial manufacture
Goal of Stage 3
process of comparing the unknown with a reference standard and adjusting the instrument response as close to the values shown by reference standards and reporting the results
Calibration
is the comparison of results against specifications
Verification
ability of a particular formulation in a specific container to remain within its pysical, chemical, therapeutic and toxicological specifications
Stability of Pharmaceutical Product
Different factors such as temperature, humidity and even light intensity can affect the quality of a pharmaceutical product
Shelf-life determination
conducted to show long a pharmaceutical product can be stored at normal or accelerated conditions without any degradation to its properties
Stability testing studies
This is the storing of pharmaceutical products and materials up to their point of use.
Storage
Different products require different storage conditions. Instability lab, storage conditions and changes in the substances are recorded.
Storage condition recommendation:
Some products, such as certain vaccines, need to be transported within a cold chain and stored at -20°C (4°F)
Store frozen
- Some products are very heat sensitive but must not be frozen.
Store at 2°-8°C (36°-46°F):
Store between 8°-15°C (45°-59°F).
Keep cool:
Store at 15°-25°C (59°-77°F).
Store at room temparature
