This document discusses quality assurance and quality control. Quality assurance refers to processes done before a project to ensure quality, such as process documentation and audits. Quality control refers to checks done on deliverables to ensure they meet standards. Both are interdependent. Accuracy and precision are important in analysis. Various charts can be used to monitor quality over time, including control charts. Validation of methods, equipment, and cleaning procedures helps ensure quality. Documentation, representative sampling, and use of standards are also discussed.

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)