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Here is the “Industrial Pharmacy Lite” summary you need for the 200 MCQs.
PCN loves to ask the difference. Remember it this way:
QA (Quality Assurance) is PROACTIVE (Process-focused):
They prevent defects before they happen.
They write the rules: SOPs, Audits, Training, Documentation.
Exam Tip: If the question asks about “designing a system” or “auditing,” it’s QA.
QC (Quality Control) is REACTIVE (Product-focused):
They find defects after they happen.
They test the product: Lab testing, Friability tests, Assay, Swab tests.
Exam Tip: If the question asks about “testing a sample” or “checking raw materials,” it’s QC.
You will likely get a calculation question on this. They will give you a “Theoretical Yield” (what you should get) and an “Actual Yield” (what you actually got).
The “Line Loss” Concept:
If you started with 100kg of powder and ended up with 98kg of granules, your Yield is 98%.
The missing 2kg is your Line Loss (stuck in the machine, spilled, etc.).
Exam Trick: If the yield is >100%, it usually means a mistake (e.g., the granules weren’t dried properly and still contain water/solvent).
Don’t mix these up!
You Qualify EQUIPMENT (Machines): You check if the machine works.
IQ (Installation Qualification): Is it installed correctly? (e.g., Is the plug connected?).
OQ (Operational Qualification): Does it run correctly? (e.g., Do the buttons work?).
PQ (Performance Qualification): Does it work consistently under load? (e.g., Can it compress 100,000 tablets without jamming?).
You Validate PROCESSES (Methods): You check if the recipe works.
Example: You validate the mixing time or the cleaning procedure to prove it removes all bacteria every time.
Summary for the Exam:
Machine = Qualification (IQ/OQ/PQ)
Method/Process = Validation
Prevents Errors = QA
Detects Errors = QC
Good luck! You’ve got this.
