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Lab Controls - Coggle Diagram
Lab Controls
Sampling, Testing & Release
Sample
- sampling method, sample size, specifications/acceptance criteria
- samples collected for testing shall be representative & adequately identified
- documented in form of SOPs/manual
Test methods
- Accuracy
- Precision
- independent of accuracy, close to 2 measurements to one another
- Sensitivity
- depends on method detection limit & response to small difference
- Specificity
- focus on target analyte only
Release
- each batch must meet all specification before release
- COA summarise test rsults must accompany every released batch
- retesting only allowed if investigation confirms testing/procedural error using predefined procedures
Quality Control (QC)
- ensure all required tests performed according to SOPs in GMP-compliant labs
- has authority to approve/reject materials
- plays broader role in product quality (review & approve procedures & specifications) that affect key quality attributes
Functions
Routine sampling
- raw materials, bulk & finished products & environmental monitoring
In-Process testing
- test process intermediates to decide next process step
Ad-hoc tesing
- test changeover, validation & investigation
Stability Testing
- long-term testing program (3-5 years) to evaluate product quality over time
- monitors active content, degradation & microorganisms
- use to set storage conditions & expiration dates
- performed on raw materials, APIs, finished products/components
- conduct in same container-closure system as marketed product
Finished Product
- Before
- define test attributes, sample size, intervals & acceptance criteria
- During
- store samples in stability chambers at set temp & humidity; test at scheduled times
- After
- trend & analyze data & submit to regulators to support shelf life
QC Lab equipment
- include measuring instrument, apparatus & recording devices
- new equipment must be commissioned & qualified
- equipment requiring accuracy must undergo regular calibration per written program
- don't use equipment if it doesn't meet established specifications
Reserve Samples
- representative, clearly identified samples kept from each batch/lot
- quantity:at least 2x amount needed for full testing
- stored under labeled conditions & in same/equivalent container-closure system
- retention period:1 year after product expiry
- may be visually inspected annually for deterioration
- include testing of freeze-dried biologics before & after reconstitution
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