Lesson 2 Flashcards
usually an internal quality process of
determining compliance with a regulation, standard, or specification; validation
Verification
is the process of checking if something satisfies a certain criterion.
Validation
Factors that contribute to obtain quality drug product:
- Personnel
- Procedure
- Equipment
- Premises
- Environment
- Packing Materials
- Starting Materials
- Validated Process
contains the quantity of each active ingredient claimed on the label, within the applicable limits of its specification.
Quality Drug Product (QDP)
Techniques in validation:
- Process and assay validation
- Validation and qualification of manufacturing equipment and existing products
- Cleaning validation
- Post validation
contains the same quantity of active ingredient from one dosage unit to the next.
Quality Drug Product (QDP)
Is free from extraneous substances
QDP
Maintains its potency, therapeutic availability and appearance until used.
QDP
upon administration, releases the active ingredient for full biological availability.
QDP
Quality Control Procedures:
• Solid dosage forms
• Non-sterile oral/topical products
• Parenterals
QCP
Solid-dosage form
Granules, Powders, Tablets, Capsules, Lozenges or Pastilles, Salonpas, etc.
QCP
Non-sterile oral/topical products:
a. solutions
b. suspensions
c. emulsions
d. microbial assay for antibiotics
e. biological assays
QCP
Parenterals (sterile)
a. dextrose
b. ampoule
c. vial
API
Active Pharmaceutical Ingredient
This test is often called “appearance” on a specification and is a qualitative description of the dosage form
Universal Test
Verify the identity of the active pharmaceutical ingredients) in the dosage form
Identification
Visual inspection for soluble matter or impurities.
Appearance
Odor, color, taste, pH, viscosity, clarity
Physical
Degradation products, potency
Chemical
Parenteral Tests
• Sterility test
• Test for pyrogens
• Safety test TERALS
• Particulate matter test
• Leaker’s test
