Transcript
QUALITY ASSURANCE
process approach
done before starting a project
process documentation, establishing standard, audits
QUALITY CONTROL
product based approach
deliverables are in good quality
begins once the product has been manufactured
Both Quality Control and Quality Assurance
- because of strong interdependence, it becomes difficult to pinpoint the difference
- very thin line that separates the 2
- in some organizations, one department performs the functions of both
Quality
Is everybodys business
Quality Control
A tool which gives assurance that product conforms to standards and specifications
Success as an Analyst
manipulative skill by experience
follow directions
knowledge of the theory
skill of technique, patience, neatness and accuracy
Accuracy and Honesty
the operator is the only person who is familiar with the entire history of the analysis
at least two determinations are required
the results should agree closely
Documentation/Notebook
include date
object or title
experimental data
reactions
calculations\results
remarks
Economy of Time
clean apparatus immediately after using
label all solutions, filtrates and precipitate
keep 2 or more operations going at one time
utilize all time between operations in making calculations and writing up experiments
1. according to measurability
a. attribute defect
cannot be measured by instrument
odor, cleanliness
b. variable defect
measured by instruments
pH, weight, thickness, conc.
2. according to seriousness or gravity
a. critical defect
endanger life or property
may render product non functional
disintegration time
b. major defect
may render product useless
cracked bottle
c. minor defect
not endanger life nor affect function
color label
3. according to nature
a. ocular defect
visible (foreign particulate)
b. internal defect
not seen
subpotent
c. performance defect
a defect in function
suppository does not melt in body temp
A. MATERIAL INSPECTION SECTION
examine raw materials received
conduct physical test packaging materials
examination on the quality of inventories
C. BIOLOGICAL TESTING LABORATORY
perform microbiological, pharmacological, sterility, toxicity tests
conduct environmental monitoring
D. ANALYTICAL DEVELOPMENT
research development
validate procedures
develop new assays
develop and improve final product
A. raw materials
1. Reception - RTR
2. quarantine
- hold sticker
- samples submitted to lab
- no stickers of different disposition
3. rejected
4. approved
B. stickers
to avoid mixups
colors:
yellow = quarantine/ hold/ pending
green = approved/ pass
red = rejected/ fail
C. printed and packaging materials – direct contact
1. primary packaging components – capsules, bottles, caps
2. secondary – labels, inserts, cartons
D. Reassay dates
the date of retest
Monthly or prior to use – highly unstable
6 months – vitamins, flavors
12 months – dyes
24 months – excipients
BATCH
Means specific amount produced in a unit time or according to single manufacturing order during same cycle of manufacture
LOT
A batch
Any portion of a batch
DISTRIBUTION CONTROL
Certificate ANTIBIOTICS and INSULIN are withheld from distribution until BATCH CERTIFICATE from BFAD is received
Average Deviation (d)
Difference between individual results and the mean, regardless of signs, adding these differences and dividing by the # of determinations
Relative average deviation
Dividing the average deviation by mean and multiplied by 100 as % or 1000 as ppt
Relative Standard Deviation (RSD)
Or coefficient of variation
Dividing the standard deviation by mean and multiply by 100
Ex.
Get the mean, average deviation, relative average deviation, standard deviation (SD) and RSD of the following values:
0.1140
0.1142
0.1152
0.1146
CONTROL CHARTS consist of:
1. Control solid line – average
2. 2 horizontal parallel lines – indicates limits
UCL (upper control limit): mean + 3 (SD)
above center line
LCL (lower control limit): mean - 3 (SD)
below center line
VALIDATION
Verification
A. Process Validation
- temperature, blending time, dissolution (rpm)
B. Assay Validation
- estimate of assay accuracy and precision
C. validation of equipment – calibration
D. validation of existing products – potency, content uniformity
E. cleaning validation – avoid contamination
F. post validation – if there is change in formulation, analytical methods
CLEANING SOLUTIONS
Sodium dichromate in sulfuric acid - best
Chromic acid
soln. of trisodium phosphate
Synthetic detergent
Source and Nature of Errors
generally, results that agree closely when obtained by 2 different methods of analysis are a good indication of the reliability of the methods
2 types errors:
1. Indeterminate errors
slight variation in a series of observations by same observer
result from causes difficult to detect such as differences in the judgment and skill of the analyst
intangible and their elimination is impossible
Random or accidental error
2. Determinate errors
Also called systematic error
recur in constant manner/error
arise from causes such as:
a. personal errors (inability to judge color change)
b. incorrect sampling, contamination, error of method
c. apparatus errors ( inaccurate calibration)
errors are detectable and so may be eliminated
Precision or reproducibility – agreement among repeated measurements
Accuracy – closeness of measurement to true value
Accuracy
denote the agreement of results
expressed in term of errors
the difference between the mean and the true value is known as the ABSOLUTE ERROR
the RELATIVE ERROR is found by dividing the absolute error by the true value and multiplied by 100
Precision
a measure of reproducibility of data within a series pf results
results within a series which agree closely with one another are said to be precise
precise results are not necessarily accurate
Constant Weight
2 consecutive weighings do not differ by more than 0.5 mg/g of substance
if 2 weights agree within 0.2 mg
Weights
substance to be accurately weighed for an assay, error is limited to 0.1% or less
a quantity of 500 mg is to be weighed to the nearest 0.5 mg
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