3. QUALITY ASSURANCE
 process approach
 done before starting a project
 process documentation, establishing standard, audits

4. QUALITY CONTROL
 product based approach
 deliverables are in good quality
 begins once the product has been manufactured

5. note:
Both Quality assurance and Quality Control are
largely interdependent

6. 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

7. Pharmaceutical and Cosmetic manufacturing:
 Comply CGMP (AO# 220 s. 1974)

8. Quality
 Is everybodys business
Quality Control
 A tool which gives assurance that product conforms to
standards and specifications

9. Success as an Analyst
 manipulative skill by experience
 follow directions
 knowledge of the theory
 skill of technique, patience, neatness and accuracy

10. 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

11. Documentation/Notebook
 include date
 object or title
 experimental data
 reactions
 calculationsresults
 remarks

12. 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

13. Reagents
 must be pure
 conform to USP and NF

14. Sampling
 secure a representative samples
 sampled from different parts, top to bottom

15. Standards and Specifications
 basis for accepting or rejecting a product

16. DEFECTS
 undesirable characteristics of a product
 failure to conform to specs

18. 1. according to measurability
a. attribute defect
 cannot be measured by instrument
 odor, cleanliness
b. variable defect
 measured by instruments
 pH, weight, thickness, conc.

19. 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

20. 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

21. SOURCES AND CONTROL OF QUALITY VARIATION
 Materials
 Machines
 Methods
 Men

23. A. MATERIAL INSPECTION SECTION
 examine raw materials received
 conduct physical test packaging materials
 examination on the quality of inventories

24. B. ANALYTICAL LABORATORY
 perform chemical and physical analysis

25. C. BIOLOGICAL TESTING LABORATORY
 perform microbiological, pharmacological, sterility,
toxicity tests
 conduct environmental monitoring

26. D. ANALYTICAL DEVELOPMENT
 research development
 validate procedures
 develop new assays
 develop and improve final product

27. E. QUALITY COORDINATION OFFICE
 maintain records
 investigate complaints
 maintain and develop SOP

29. A. raw materials
1. Reception - RTR
2. quarantine
- hold sticker
- samples submitted to lab
- no stickers of different disposition
3. rejected
4. approved

30. B. stickers
 to avoid mixups
 colors:
yellow = quarantine/ hold/ pending
green = approved/ pass
red = rejected/ fail

31. C. printed and packaging materials – direct contact
1. primary packaging components – capsules, bottles,
caps
2. secondary – labels, inserts, cartons

32. D. Reassay dates
 the date of retest
Monthly or prior to use – highly unstable
6 months – vitamins, flavors
12 months – dyes
24 months – excipients

33. 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

34. DISTRIBUTION CONTROL
 Certificate ANTIBIOTICS and INSULIN are withheld
from distribution until BATCH CERTIFICATE from
BFAD is received

36. Mean
 average

37. Average Deviation (d)
 Difference between individual results and the mean,
regardless of signs, adding these differences and
dividing by the # of determinations

38. Relative average deviation
 Dividing the average deviation by mean and
multiplied by 100 as % or 1000 as ppt

39. Standard Deviation (sd, s)
 Preferred measure of precision

41. Relative Standard Deviation (RSD)
 Or coefficient of variation
 Dividing the standard deviation by mean and multiply
by 100

42. Range (R)
 Largest and smallest values

43. 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

44. QC CHARTS:
2 types:
1. attribute chart
 P chart (control chart for fraction defective)

45. 2. variable chart –
 use of actual records of numerical measurement
ex. meter, grams
 X and R charts

47. 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

48. VALIDATION
 Verification
A. Process Validation
- temperature, blending time, dissolution (rpm)
B. Assay Validation
- estimate of assay accuracy and precision

49. 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

50. CLEANING SOLUTIONS
 Sodium dichromate in sulfuric acid - best
 Chromic acid
 soln. of trisodium phosphate
 Synthetic detergent

51. CALCULATION OF RESULTS AND ERRORS

52. 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

53. 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

54. 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

56.  Precision or reproducibility – agreement among
repeated measurements
 Accuracy – closeness of measurement to true value

57. 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

58. 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

60. 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

61. Analytical Balance
 double pan
 single pan
 top
 analytical

62. 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

63. Dessicators
 Vessel rendered airtight
 Maintain dry atmosphere
 Has dehydrating agent/ dessicant (silica gel, calcium
chloride)