Presentation on quality control and quality assurance of medicines by tite uwambajineza

A.PRESENTATION ON QUALITY ASSURANCE AND QUALITY CONTROL
OF MEDICINES
PRSENTED BY :
Phn Tite UWAMBAJINEZA, B.Pharm,M.Pharm
RWANDA STANDARDS BOARD
MEDICAL AND PHARMACEUTICAL TESTING UNIT
Mail:uwatito@gmail.com
Tel & Whatsap+250788297415
24/03/2018
What is Quality?
The totality of features and characteristics of a product or
service that bear on its ability to satisfy stated needs (ISO
definition).
2
Pharmaceutical quality control
Pharmaceutical quality control—Process concerned with
medicine sampling, specifications, and testing, and with
the organization’s release procedures that ensure that the
necessary tests are carried .
3
Pharmaceutical quality assurance (QA)
Pharmaceutical quality assurance (QA)—Sum of
all activities and responsibilities required to ensure
that the medicine that reaches the patient is safe,
effective, and acceptable to the patient(WHO)
Goals of Medicine QA Programs
To make certain that each medicine reaching a patient is safe,
effective, and of standard quality
Impacts of Low-Quality Medicines
 Manufacturing
process
 Packaging
 Transportation
 Storage
condition
?
MEDICINE
QUALITY
 Lack of therapeutic
effect:
 Prolonged illness
 Death
 Toxic and adverse
reaction
 Waste of limited
financial resources
 Loss of credibility
Determinants of Medicine Quality
Identity: Active ingredient
Purity: Not contaminated with potentially harmful
substances
Potency: Usually 90–110% of the labeled amount(MOST OF
CASE)
Uniformity: Consistency of color, shape, size
Bioavailability: Interchangeable products?
Stability: Ensuring medicine activity for stated period
How Is Quality Assessed?
 INSPECTION of products on arrival
 Visual inspection
 Product specification review (including
expiration dates)
 LABORATORY TESTING for compliance
with pharmacopoeial standards
 International Pharmacopoeia
 European Pharmacopoeia
 U. S. Pharmacopeia
 British Pharmacopoeia
 National Pharmacopoeia
 BIOAVAILABILITY DATA
How Is Medicine Quality Assured?
 Product selection
 Long shelf-life
 Acceptable stability
 Acceptable bioavailability
 Selection of appropriate suppliers
 Supplier pre-qualification
 Product certification
 GMP certificate of manufacturer
 Product/batch certification (COA)
 Contract and procurement specifications
 Pharmacopeia reference standard
 Standards for packaging to meet specific
storage and transport conditions
 Appropriate storage, transport, dispensing, and
use procedures
Who Ensures Medicine Quality?
Medicine
Quality
 Physicians
and other
prescribers
 Drug and
Therapeutics
Committee
 Hospital
procurement
office
 Pharmacy
(and dispensers)
 Patients
Medicine
Quality
 Physicians
and other
prescribers
 Drug and
Therapeutics
Committee
 Hospital
procurement
office
 Pharmacy
(and dispensers)
 Patients
Presentation  on quality control and quality assurance of medicines  by tite uwambajineza
Thickness and diameter
Weight variation
Hardness
Friability
Drug content
Disintegration time
In- vitro dissolution
QUALITY CONTROL OF CAPSULES
Disintegration
Dissolution
Identification of API
Uniformity of weight
Uniformity of dosage form
Assay of API
General Appearance:
-Size, shape, and thickness:
-Organoleptic properties:
which include color, taste and odor of the tablets.
Thickness can vary with no change in weight
due to:
a- Difference in the density of the granulation
b- The pressure applied to the tablets.
c- The speed of tablet compression.
Hardness (crushing strength):
It is the load required to crush the tablet when placed
on its edge.
Why do we measure hardness?
To determine the need for pressure adjustments on the
tableting machine.
To withstand the mechanical shocks of manufacturing,
packaging, and shipping,
To ensure consumer acceptance.
• Hardness can affect the disintegration. So if the tablet is
too hard, it may not disintegrate in the required period of
time.
• And if the tablet is too soft, it will not withstand the
handling during subsequent processing such as coating
or packaging.
• In general, if the tablet hardness is too high, we first
check its disintegration before rejecting the patch.
• And if the disintegration is within limit, we accept the
patch.
Factors Affecting the Hardness:
Compression of the tablet and compressive force.
Amount of binder. (More binder a more hardness)
Method of granulation in preparing the tablet
Limits:
• Oral tablets have a hardness of 4 to 10kg or 39.2 to
98.08665N ; but, hypodermic and chewable tablets
have a hardness of 3 kg .
• and sustained release tablets have about 10-20
kg(98.08665 to 196.1N).
• Make hardness test on 5 tablets and then take the
average hardness.
Friability:
It is the tendency of tablets to powder, chip, or fragment
and this can affect the elegance appearance, consumer
acceptance of the tablet, and also add to tablet’s weight
variation or content uniformity problems.
An instrument called friabilator or friability tester is
used to evaluate the ability of the tablet to withstand
abrasion in packaging, handling, and shipping.
Procedure:
1. Weigh 20 tab altogether
2. Put these tablets in the friabilator and adjust the instrument at
100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones)
F = 100 × (1-w/w0)
Where w0 = weight of tablets before friability
w = weight of tablets after friability
4. Friability (% loss) = It must be less than or equal to1% but
Some chewable tablets and most effervescent tablets are highly
friable and require special unit packaging.
Weight Variation
(uniformity of weight) of tablets:
1. Weigh 20 tablet selected at random, each one individually .
X1, X2, X3… Xz
2. Determine the average weight. X= (X1+X2 +X3+…+
Xz)/20
Limits according to U.S.P
Average mass of
Tablet
Deviation % Number of tablets
Less than 80 mg ±10.0 Minimum 18
±20.0 maximum 2
80 mg to 250 mg ±7.5 Minimum 18
±15.0 maximum 2
More than 250 mg ±5.0 Minimum 18
±10.0 maximum 2
WEIGHT UNIFORMITY
FOR CAPSULES
Net mass of capsules
contents
Deviation
%
Number of capsules
less than 300 mg ±10.0 minimum 18
±20.0 maximum 2
300 mg and over ±7.5 minimum 18
±15.0 Maximum 2
Content Uniformity Test:
• Randomly select 30 tablets. 10 of these assayed
individually.
• The Tablet pass the test if 9 of the 10 tablets must
contain not less than 85% and not more than 115%of
the labeled drug content
• and the 10th tablet may not contain less than 75% and
more than 125% of the labeled content.
• If these conditions are not met, remaining 20 tablet
assayed individually and none may fall out side of the
85 to 115% range.
.
Disintegration:
• Disintegration test is performed to see how
much time a tablet takes to break down in to the
small particles as this is first step before the
drug dissolution in the body
• USE The Disintegration apparatus
• The basket rack is immersed in a bath of suitable liquid,
• held at 37°, preferably in a 1 -L beaker.
• The rack moves up and down in the fluid at a specified rate.
• For compressed uncoated tablets the testing fluid is usually
water at 37°,
• but in some cases the monographs direct that simulated
gastric fluid be used.
Liquids used in
disintegration
Water,
simulated gastric fluid (PH =
1.2 HCl),
or Simulated intestinalfluid
• For most uncoated tablets the period is not more than 15
minutes according to USP
• although the time for some uncoated tablets varies greatly,
from this. For coated tablets up to 2 hours may be
required, while for sublingual tablets, the disintegration time
is 3 minutes.
U.S.P. method for uncoated tablets AND capsules
Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate
completely within 15 min repeat the same test on another 12
tablet. (i.e. the whole test will consume 18 tablets).
Not less than 16 tablets disintegrate completely within thetime
if more then two tablets (from the 18) fail to disintegrate, the
batch must be rejected.
• the uncoated tablets pass the test if all of them have
disintegrated in not more than 15 minutes.
• Capsules pass the test if all of them have disintegrated in not
more than 30 minutes
6) Dissolution test
• Dissolution is the process by which a solid enters a
solution .
• The dissolution rate is defined as the amount of drug
substance that goes into solution per time under
standardized conditions of liquid / solid interface,
temperature, and solvent composition .
• Dissolution is one of most important quality control tests
and consider as tool for predicating bioavailability.
• A variety of designs of apparatus for dissolution testing is
varying from simple beaker to complex system.
The choice of the apparatus to be used depends largely on
the physicochemical properties of the dosage form.
DISSOLUTION TEST WITH BASKET
APPARATUS AFTER ANALYSING
AMOXICILLIN CAPSULE SAMPLES
Apparatusa Name Drug Product
Apparatus 1 Rotating basket Tablets
Apparatus 2 Paddle Tablets, capsules, modified drug products,
25
27
28
This apparatus is identical to apparatus 1 except
that the paddle is substituted for the rotating basket
Frequently used for both disintegrating and non-
disintegrating dosage forms
36
All 6 tablets must meet the requirements specific. If one or
two tablets failed, repeat the test on 6 additional tablets .
• Various pharmacopoeias contain specifications on dissolution
requirements of various drugs. ( monograph specifies : stirring
speed, temperature, viscosity, pH, composition of dissolution
media and presence or absence of wetting agent)
other parameters:
• % Assay: Quantitative test using
HPLC,UV,FTIR,HPTLC,titration method
Presentation  on quality control and quality assurance of medicines  by tite uwambajineza
Presentation  on quality control and quality assurance of medicines  by tite uwambajineza
Presentation  on quality control and quality assurance of medicines  by tite uwambajineza
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Presentation on quality control and quality assurance of medicines by tite uwambajineza

  • 1. A.PRESENTATION ON QUALITY ASSURANCE AND QUALITY CONTROL OF MEDICINES PRSENTED BY : Phn Tite UWAMBAJINEZA, B.Pharm,M.Pharm RWANDA STANDARDS BOARD MEDICAL AND PHARMACEUTICAL TESTING UNIT Mail:uwatito@gmail.com Tel & Whatsap+250788297415 24/03/2018
  • 2. What is Quality? The totality of features and characteristics of a product or service that bear on its ability to satisfy stated needs (ISO definition). 2
  • 3. Pharmaceutical quality control Pharmaceutical quality control—Process concerned with medicine sampling, specifications, and testing, and with the organization’s release procedures that ensure that the necessary tests are carried . 3
  • 4. Pharmaceutical quality assurance (QA) Pharmaceutical quality assurance (QA)—Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient(WHO)
  • 5. Goals of Medicine QA Programs To make certain that each medicine reaching a patient is safe, effective, and of standard quality
  • 6. Impacts of Low-Quality Medicines  Manufacturing process  Packaging  Transportation  Storage condition ? MEDICINE QUALITY  Lack of therapeutic effect:  Prolonged illness  Death  Toxic and adverse reaction  Waste of limited financial resources  Loss of credibility
  • 7. Determinants of Medicine Quality Identity: Active ingredient Purity: Not contaminated with potentially harmful substances Potency: Usually 90–110% of the labeled amount(MOST OF CASE) Uniformity: Consistency of color, shape, size Bioavailability: Interchangeable products? Stability: Ensuring medicine activity for stated period
  • 8. How Is Quality Assessed?  INSPECTION of products on arrival  Visual inspection  Product specification review (including expiration dates)  LABORATORY TESTING for compliance with pharmacopoeial standards  International Pharmacopoeia  European Pharmacopoeia  U. S. Pharmacopeia  British Pharmacopoeia  National Pharmacopoeia  BIOAVAILABILITY DATA
  • 9. How Is Medicine Quality Assured?  Product selection  Long shelf-life  Acceptable stability  Acceptable bioavailability  Selection of appropriate suppliers  Supplier pre-qualification  Product certification  GMP certificate of manufacturer  Product/batch certification (COA)  Contract and procurement specifications  Pharmacopeia reference standard  Standards for packaging to meet specific storage and transport conditions  Appropriate storage, transport, dispensing, and use procedures
  • 10. Who Ensures Medicine Quality? Medicine Quality  Physicians and other prescribers  Drug and Therapeutics Committee  Hospital procurement office  Pharmacy (and dispensers)  Patients Medicine Quality  Physicians and other prescribers  Drug and Therapeutics Committee  Hospital procurement office  Pharmacy (and dispensers)  Patients
  • 12. Thickness and diameter Weight variation Hardness Friability Drug content Disintegration time In- vitro dissolution
  • 13. QUALITY CONTROL OF CAPSULES Disintegration Dissolution Identification of API Uniformity of weight Uniformity of dosage form Assay of API
  • 14. General Appearance: -Size, shape, and thickness: -Organoleptic properties: which include color, taste and odor of the tablets.
  • 15. Thickness can vary with no change in weight due to: a- Difference in the density of the granulation b- The pressure applied to the tablets. c- The speed of tablet compression.
  • 16. Hardness (crushing strength): It is the load required to crush the tablet when placed on its edge. Why do we measure hardness? To determine the need for pressure adjustments on the tableting machine. To withstand the mechanical shocks of manufacturing, packaging, and shipping, To ensure consumer acceptance.
  • 17. • Hardness can affect the disintegration. So if the tablet is too hard, it may not disintegrate in the required period of time. • And if the tablet is too soft, it will not withstand the handling during subsequent processing such as coating or packaging. • In general, if the tablet hardness is too high, we first check its disintegration before rejecting the patch. • And if the disintegration is within limit, we accept the patch.
  • 18. Factors Affecting the Hardness: Compression of the tablet and compressive force. Amount of binder. (More binder a more hardness) Method of granulation in preparing the tablet Limits: • Oral tablets have a hardness of 4 to 10kg or 39.2 to 98.08665N ; but, hypodermic and chewable tablets have a hardness of 3 kg . • and sustained release tablets have about 10-20 kg(98.08665 to 196.1N).
  • 19. • Make hardness test on 5 tablets and then take the average hardness. Friability: It is the tendency of tablets to powder, chip, or fragment and this can affect the elegance appearance, consumer acceptance of the tablet, and also add to tablet’s weight variation or content uniformity problems.
  • 20. An instrument called friabilator or friability tester is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping.
  • 21. Procedure: 1. Weigh 20 tab altogether 2. Put these tablets in the friabilator and adjust the instrument at 100 rpm (i.e. = 25 rpm for 4 min) 3. Weigh the 20 tablets (only the intact ones) F = 100 × (1-w/w0) Where w0 = weight of tablets before friability w = weight of tablets after friability 4. Friability (% loss) = It must be less than or equal to1% but Some chewable tablets and most effervescent tablets are highly friable and require special unit packaging.
  • 22. Weight Variation (uniformity of weight) of tablets: 1. Weigh 20 tablet selected at random, each one individually . X1, X2, X3… Xz 2. Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20
  • 23. Limits according to U.S.P Average mass of Tablet Deviation % Number of tablets Less than 80 mg ±10.0 Minimum 18 ±20.0 maximum 2 80 mg to 250 mg ±7.5 Minimum 18 ±15.0 maximum 2 More than 250 mg ±5.0 Minimum 18 ±10.0 maximum 2
  • 24. WEIGHT UNIFORMITY FOR CAPSULES Net mass of capsules contents Deviation % Number of capsules less than 300 mg ±10.0 minimum 18 ±20.0 maximum 2 300 mg and over ±7.5 minimum 18 ±15.0 Maximum 2
  • 25. Content Uniformity Test: • Randomly select 30 tablets. 10 of these assayed individually. • The Tablet pass the test if 9 of the 10 tablets must contain not less than 85% and not more than 115%of the labeled drug content • and the 10th tablet may not contain less than 75% and more than 125% of the labeled content. • If these conditions are not met, remaining 20 tablet assayed individually and none may fall out side of the 85 to 115% range. .
  • 26. Disintegration: • Disintegration test is performed to see how much time a tablet takes to break down in to the small particles as this is first step before the drug dissolution in the body
  • 27. • USE The Disintegration apparatus • The basket rack is immersed in a bath of suitable liquid, • held at 37°, preferably in a 1 -L beaker. • The rack moves up and down in the fluid at a specified rate. • For compressed uncoated tablets the testing fluid is usually water at 37°, • but in some cases the monographs direct that simulated gastric fluid be used.
  • 28. Liquids used in disintegration Water, simulated gastric fluid (PH = 1.2 HCl), or Simulated intestinalfluid
  • 29. • For most uncoated tablets the period is not more than 15 minutes according to USP • although the time for some uncoated tablets varies greatly, from this. For coated tablets up to 2 hours may be required, while for sublingual tablets, the disintegration time is 3 minutes.
  • 30. U.S.P. method for uncoated tablets AND capsules Start the disintegration test on 6 tablets. If one or two tablets from the 6 tablets fail disintegrate completely within 15 min repeat the same test on another 12 tablet. (i.e. the whole test will consume 18 tablets). Not less than 16 tablets disintegrate completely within thetime if more then two tablets (from the 18) fail to disintegrate, the batch must be rejected. • the uncoated tablets pass the test if all of them have disintegrated in not more than 15 minutes. • Capsules pass the test if all of them have disintegrated in not more than 30 minutes
  • 31. 6) Dissolution test • Dissolution is the process by which a solid enters a solution . • The dissolution rate is defined as the amount of drug substance that goes into solution per time under standardized conditions of liquid / solid interface, temperature, and solvent composition . • Dissolution is one of most important quality control tests and consider as tool for predicating bioavailability.
  • 32. • A variety of designs of apparatus for dissolution testing is varying from simple beaker to complex system. The choice of the apparatus to be used depends largely on the physicochemical properties of the dosage form.
  • 33. DISSOLUTION TEST WITH BASKET APPARATUS AFTER ANALYSING AMOXICILLIN CAPSULE SAMPLES
  • 34. Apparatusa Name Drug Product Apparatus 1 Rotating basket Tablets Apparatus 2 Paddle Tablets, capsules, modified drug products,
  • 35. 25
  • 36. 27
  • 37. 28 This apparatus is identical to apparatus 1 except that the paddle is substituted for the rotating basket Frequently used for both disintegrating and non- disintegrating dosage forms
  • 38. 36 All 6 tablets must meet the requirements specific. If one or two tablets failed, repeat the test on 6 additional tablets .
  • 39. • Various pharmacopoeias contain specifications on dissolution requirements of various drugs. ( monograph specifies : stirring speed, temperature, viscosity, pH, composition of dissolution media and presence or absence of wetting agent)
  • 40. other parameters: • % Assay: Quantitative test using HPLC,UV,FTIR,HPTLC,titration method