Quality Control Flashcards
Sum total of the organized arrangements made w/ the object of ensuring that products will be consistently of the quality required by their intended use
Quality Assurance
Totality of characteristics or features of a product that bear on its capacity to satisfy stated or implied needs
It is the combination of attributes or characteristics of a product which when compared to a standard, serves as a basis for reassuring the uniformity of the product and determines its degree of acceptability
Quality
Part of GMP concerned w/ sampling, specifications, testing organization, documentations, and release procedures.
Quality Control
Production of a drug or cosmetics of the HIGHEST STANDARD at the LOWEST COST
Goal
In manufacturing firm it is common
- Financing
- Production
- QA/QC
- Marketing
All manufacturing must be done in compliance _______________
w/ CURRENT GOOD MANUFACTURING PRACTICE or cGMP.
For this reason, _________________ is included in its Appendix
ADMINISTRATIVE ORDER NO. 220 S 1974
The Potential Benefits from QC System
- The system minimizes or eliminates the risk of marketing unsafe products
- It guarantees conformance to regulatory requirements
- It guarantees product efficacy
- It reduces operating costs
- It reduces operating losses
- It produces higher employee morale
- It motivates the pharmaceutical and medical professionals to sell the product
Quality Assurance VS Quality Control
QA
- Describe the overall organizational body designed to assure the quality of the product
QC
- Function within the total control effort responsible for in-line or in-process testing
QA Functions
- Testing & acceptance of only highly quality raw materials, representative samples.
- IP tests against criteria
- Monitors environmental conditions (depends on products)
- Control packing components
3 Main Areas of QC (Analytical Test)
- Raw Materials Quality Control
- In - Process Quality Control
- Finished Producy Quality Control
Volume fill
Detection of particles
In-Process Quality Control
ACTIVE INGREDIENT: ID TEST
SOLVENT: PYROGEN TEST
GLASS: WATER ATTACK/POWDERED GLASS TEST
RUBBER: DUROMETER TEST (also in plastics)
Raw Material Quality Control
Stability test
Leaker test
Sterility test
Finished Product Quality Control
Quality characteristics are interpreted by descriptive words and measurements however are subject to variation
Standards and Specifications
Quality variation, which is not confined within specific range, tolerance/limit will grow to uncontrollable magnitude and encourage _________
ERRORS
may be due to assignable cause such as materials, machines, methods and men
ERRORS
To avoid producing defective products, standards, and specifications are developed to serve as a basis for accepting or rejecting a product. These are some of the ff. points
- Formula
- Raw materials specification
- Standard operating procedure
- Finished product specification
- Packaging material standard
- Testing materials
concise and precise statement of the ingredients that comprise the product, together with the percentage and or the weight of each.
Formula
enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.
Raw materials specification
step by step method on how to go about a job
Standard operating procedure
cover of characteristics that affect the proper performance, purity, safety, and stability of the product
Finished product specification
set of everything that goes around the product (ex. Bottles, cans, aluminum foil).
Packaging material standard
Packaging must be considered with the following points in mind.
- Units must run-on high-speed line
- Involve complicated assembly
- The package must be functional
- Package must be completely compatible w/ the product
- The package must protect the product and assure its stability
- The package must ship well
indispensable in ensuring conformity to
Testing materials
- Undesirable characteristics of a product
- Failure to conform to specifications
Defects
A unit of a product that contains one or more defects is called ___________
Defective
Characteristics of Defect
ACCORDING TO MEASURABILITY
ACCORDING TO NATURE
ACCORDING TO SERIOUSNESS OR GRAVITY
ACCORDING TO SERIOUSNESS OR GRAVITY
Minor defect
Major defect
Critical defect
ACCORDING TO NATURE
Ocular defect
Internal defect
Performance defect
ACCORDING TO MEASURABILITY
Attribute defect
Variable defect
endanger life or property and may render the product non-functional
Examples: absence of warning label of a potent drug, disintegration time of one hour for an analgesic
Critical defect
will not endanger life nor affect the function of product but still consider the product defective. Does not affect the efficacy of the drug.
Examples: slight deviation of color label from color standard
Minor defect
affect the function of the product, rendering the product useless
Examples: cracks in the bottle
Major defect
defect in function
Examples: suppository does not melt at body temp.
Performance defect
visible
Example: contamination
Ocular defect
not seen but present
Example: sub-potent drug
Internal defect
measured dreadly by the instruments (objective)
Examples: length, weight, height, thickness, concentration, volume, viscosity, pH or size particles
Variable defect
cannot be measured directly by instruments (subjective)
Examples: odor, visual examinations, clarity, sheen, cleanliness, smoothness, taste
Attribute defect
Sources of Variation
MATERIALS
MACHINES
METHODS
MEN
- Variation between suppliers of same substance
- Variation between batches from same supplier
- Variation within batch
MATERIALS
Inexact procedures
Inadequate procedures
Negligence by chance
METHODS
Improper working conditions
Inadequate training, and understanding
Dishonesty, fatigue, and carelessness
MEN
Variation of equipment for the same process
Difference in adjustment of equipment
MACHINES
To sample and examine all raw materials received
To maintain periodic examination on quality of inventories
To perform an adult which is independent of the work done by production personnel
To sample and conduct physical tests on
Materials Inspection Section
- Protected from noise & vibration
- Perform physical & chemical analysis (gravimetric and volumetric)
Analytical Laboratory
- Perform simple & complex microbiological procedures and biological interactions
- Evaluate microbiological & pharmacological assays, sterility, pyrogen, and bacteriological tests, irrigation, safety or acute toxicity tests.
- Conduct environmental monitoring
Biological Testing Laboratory
- To coordinate w/ research, product development, production sales, & management towards improvement of a product
To establish specifications of raw and packaging materials
To validate existing and tentative procedures of testing
To establish specifications based on validated procedures
To develop new assay methods for in-house use
To develop and improve specifications for quality characteristics of the final product being manufactured
Specification & Analytical Development
To maintain and store records that present the history of the batch from to start to finish
Furnish data will aid in analyzing product performance in the market
Investigate customer complaints or inquiries on product quality and toward feedback to sales organization
Call the attention of the appropriate development group any aspect in product development
Provide data that give scientific and legal status
Maintain and develop SOP
Quality Coordination Office
