Quality assurance and quality control are important parts of pharmaceutical quality management. Quality assurance focuses on preventing defects by ensuring proper development and manufacturing processes, while quality control identifies defects by testing raw materials, in-process samples, and finished products. Both are necessary to ensure pharmaceutical products meet specifications and are safe and effective. Pharmacopeias are official compendia that set standards for identity, purity, quality, and strength of drugs. They define tests and acceptance criteria for pharmaceutical ingredients and products.

1. Basic concept of Quality Control
and
Quality Assurance.
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By: zenebe k(B.pharm, MSc)
Chapter one:

2. Contents ---introduction to pharmaceutical analysis I
S.No.03 Topics Slide No.
1. Quality Management System 03
2. Principles of Quality Management 05
3. Quality Assurance and its functions 07
4. Quality Control and its functions 09
5. Difference between Quality Assurance and Quality
Control
10
6. Interrelationship between QA, QC, GMP and
Production
12
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3. Pharmaceutical analysis:
 It is a science which deals with identification, characterization and
quantification of drugs in raw materials, dosage forms and biological
fluids or
 It is an applied science that ensures the safety, efficacy and stability
of pharmaceutical products by using physical, chemical, biological,
pharmacological and biopharmaceutical methods; and
 It is also a technique that is used in elucidation(make clear,explain) of
drug entities from natural products.
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1. Introduction to pharmaceutical…..

4.  Generally, pharmaceutical analysis procedures may be used to answer
any of the questions below:
◦ Do the identity and purity of a pure drug substance meet specification?
◦ What is the percentage of the stated content of a drug present in a formulation?
◦ Does this formulation contain solely the active ingredient or are additional impurities
present?
◦ What is the stability of a drug in the formulation and hence the shelf–life of the
product?
◦ Do the identity and purity of excipients meet specification?
◦ What are the physical constants like Pka value (s), solubilities, stability etc of a drug
substance under development?
◦ At what rate is the drug released from its formulation so that it can be absorbed by the
body.
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1. Introduction to pharmaceutical…..

5.  Scope (areas) of pharmaceutical (drug) analysis:
 Pharmaceutical industry
 Raw material control
 In-process control
 Dosage form control
 Government drug control laboratory (regulatory agencies)
»Manufacture lab. Procedure control
»Products control
 Analysis means a detailed examination or study
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1. Introduction to pharmaceutical…..

6.  Pharmaceutical research labs
 Advanced research
 Development of analytical method
 Process development
 Stability studies
 Basic research
 Separation, Identification, Quantification, Molecular characterization
 Laboratories requiring pharmaceutical analysis:
 Government regulatory agencies
 Manufacture of raw materials for drugs
 University and other non-commercial research centers

7. Quality Management System
Quality:
Quality is defined as degree of excellence of a product or process.
Quality Management System (QMS):
Quality Management System is defined as a system that determines
and implements the quality policy.
Examples of QMS include: 1.ISO Quality Standards
2. MBNQA Programm
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8. 1. ISO (International organization for standardization) Quality
Standards: ISO is an organization which sets international standards
for Quality Management System. For ex. ISO 9000: Quality
management and Quality Assurance Standards-Guidelines for
selection and use.
2. MBNQA (Malcolm Baldrige National Quality Award) Programm:
MBNQA is presented by U.S. President to organisations that
demonstrate Quality and Performance excellence.
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9. Principles of Quality Management:
Principles Explanation
Principle 1- Customer focus Organizations depend on their customers therefore
they should understand and meet customer needs.
Principle 2- Leadership Leaders establish unity of purpose and direction of an
organization.
Principle 3- Involvement of people People at all levels are the essence of an organization
and their full involvement enables their abilities to be
utilized for the organizations’ benefit.
Principle 4- Process approach A desired effect is realised more efficiently when the
related resources and activities are managed as a
process.
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10. Principle 5- System approach to management Identifying, understanding and managing a system
of interrelated processes for a given objective
improves the organization's efficiency and
effectiveness.
Principle 6- Continual improvement Continual improvement should be the permanent
objective of the organization.
Principle 7- Factual approach to decision making Effective decisions are based on the examination of
data and information.
Principle 8- Mutual beneficial supplier relationships An organization and it's suppliers are
interdependent and a mutually benieficial
relationship increases their ability to create value.
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11. Quality Assurance:
• Quality Assurance is focused on building quality into a product
through planned and systematic activities like validation, process and
environmental control, and documentation.
• Goal of QA: Improve development process so that defects don't arise.
• Thus, it is a sum total of all the organised arrangements made with
the object of ensuring the production of quality product.
• ISO 9000 defines Quality Assurance as part of quality management
focused on providing confidence that quality requirements will be
fulfilled.
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12. Functions of Quality Assurance:
1. To carry out Self inspection and quality audits.
2. To investigate and record any deviations in results.
3. To ensure whether the products are designed and developed in
accordance with GMP and other associated codes such as GLP and
GCP.
4. To ensure that in-process controls, calibrations, and validations are
carried out.
5. To ensure that regular evaluations are carried out with the objective
of verifying consistency of process.
6. To establish documents. (documentation)
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13. Quality Control
• Quality control involves
operational techniques and
activities that are used to assure
product compliance to
specification.
• Goal of QC: Improve final
products by identifying defects.
• It is concerned with sampling,
testing and performing inprocess
quality control tests during and
after manufacturing.
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14. Functions of QC:
• Performs inspections.
• Performs in process quality control tests for samples.
• Perform testing of raw materials.
• Perform testing for finished products before dispatch.
Components of QC:
• Sampling
• QC labs
• Batch inspection
• Maintenance of records
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15. Difference between Quality Control and
Quality Assurance.
Quality Assurance
• QA is process oriented.
• QA aims at defect prevention.
• QA's Goal: Improve the
development process so that
defects don't arise.
• QA is company based.
Quality Control
• QC is product oriented.
• QC aims at defect identification.
• QC's Goal: Improve the final
product by identifying defects.
• QA is laboratory based.
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16. Quality Assurance
• ISO 9000 defines QA as a part of
quality management focused on
providing confidence that quality
requirements will be fulfilled.
• Jobs of QA
a. Documentation
b. Validation
c. Process and environmental control
Quality Control
• ISO 9000 defines QC as a part of
quality management focused on
fulfilling quality requirements.
• Jobs of QC
a. Sampling
b. Drug testing
c. Documentation
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17. Interrelationship
between QA, GMP, QC
& Production.
• QM: Quality management
with the overall policy of
the organization towars
quality, comes above
everything else.
• QA: Next comes QA which
ensures that the required
product quality is achieved.
• GMP: GMP is a part of QA,
GMP guidelines build
quality into the product.
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18. • QC: QC is a part of GMP, that is focused on testing of materials,
compounds and products in accordance with standards
• Production: Production department is the center of Quality
Management System. The quality of production process is
monitored by:
1. Self inspections
2. Release controls
3. Inprocess controls
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19. 15
• Self inspection: Self inspection is programme designed to detect
any shortcomings in the implementation of GMP to recommend
necessary corrective actions.
• Release controls: Release controls are the tests performed on
the products that are to be released and distributed to the
commercial marketplace.
• In process controls: This refers to the checks performed during
an activity in order to monitor and if necessary to adjust the
process and/ or to ensure that the intermediate or finished
product confirms to its specifications.

20. 1.2.The compendia

21.  It is a collection of concise but detailed information about a drug.
 Pharmacopeias and formularies are books of standards for pharmaceuticals and
medical devices containing specifications and procedures of tests.
 They are collectively referred as the drug compendia.
 Published by the authority of a government or a medical or pharmaceutical society.
The main objective of the compendia:
 To control the quality of medicine as pre standard
 To ensure the public health
 To support the availability of safe, effective, good quality pharmaceutical
care for all
 Drug compendia are sub classified as official and non-official
1.2. Drug compendia(collection of facts on a subject)

22. The compendia (cont…)
1. Official compendia
 It is a collection of list of drugs and devices which have been recognized as legal
standards of purity, quality and strength that is accepted by some recognized
authority.
Pharmacopeia
 It is a book containing a list of medicinal substances, their dosage forms or devices
with descriptions of test methods, specifications for purity and strength accepted by
some recognized authority.
 The recognized authority which issue the books of standards in most countries is the
government
 In some countries e.g. USA both the national pharmacopoeia and national formularies
are published by a private non profit making organizations

24. The compendia (cont…)
 Components and specification requirements of pharmaceutical dosages:
Excipients: therapeutically inactive but have indirect effect on like the rate of
release (dissolution and disintegration) of the medicament.
 They should be safe( non toxic), not having any interference with the
therapeutic activity and analytical procedure
Active components: therapeutically active form of a drug.
 They should have the highest attainable standard in terms of chemical
purity and biological response

25. The compendia (cont…)
Some specification requirements for pure drugs (API):
 Description: Crystalline, amorphous, etc.
 Solubility
 Identification tests
 Physical constants
 Limit tests for classically well known toxicants
 Assay
 Limit of degradation products

26. The compendia (cont…)
Specification requirements of dosage forms:
 Identification
 Assay ( with reference to label claim)
 Disintegration
 Dissolution
 Content uniformity tests
 Packaging and storage

27. The compendia (cont…)
The following are some of the representatives:
 United States Pharmacopeia and National formulary (USP and NF)
 British Pharmacopoeia ( BP)
 International Pharmacopoeia (PhI)
 European Pharmacopoeia (Ph. Eur.)
 Indian Pharmacopeia (IP), etc
 Pharmacopeias or formularies are generally national in origin and
scope

28. The compendia (cont…)
2. Non official compendia
 These are secondary reference sources that are not subject to categories of
official compendia. They include treatises, monographs and text books.
 Treatise: it is a comprehensive, exhaustive, systematic or critical approach to a
broad topic or whole field of knowledge.
 It is generally written for specialist in a given field.
 Monograph: is a work of writing upon a single subject, usually by a single author.
 It is by definition a single document that forms a complete text in itself

29. The compendia (cont…)
 Text books: They concentrate on principle rather than on details of the
last minute (very latest) development in the field.
 Martindale (Extrapharmacopeia)- is based on published information
 it is not a book of standard hence the inclusion of a substance or
preparation is neither to be considered as a recommendation for use
nor confer any status on substance or preparation.
 Its main objectives are to provide practicing pharmacists and
physicians with unbiased evaluated information on drugs and
medicaments (proprietary preparations) used through out the world

30. The compendia (cont…)
Components of pharmacopoeia
a) General notices:
 General notices provide the overall guiding principles for using the monographs and general
chapters. It mainly clarifies information provided in the pharmacopoeia to the reader.
EXAMPLES
 Tolerances: e.g. Aspirin:-should have not less than 99.5% and not more than 100.5% of
the label claim. Reason for tolerances: -Assay errors
- Basic compounding or manufacturing errors
- Detection of chemical substances
 Tests and assays:
 About: approximately (fairly correct or accurate; near to the actual value).
 Exactly: implies an error of 0.1% in the case of weighing or 0.05ml in a 50.0ml burette
 Corresponds: similar or equivalent in character or quantity.

31. The compendia (cont…)
 water bath' means a bath of boiling water, unless water at some other
temperature is indicated in the text
 Drying to constant weight: means that drying shall be continued until two
consecutive weighing do not differ by more than 0.5mg per gram and weighing
should be 1hr apart.
 Blank determination: conducted in exactly same manner as in the assay or test
except that there is no sample.
 Indicators: implies usually approximately 0.2ml or 3 drops of indicators
solution

32. The compendia (cont…)
 Packaging storage and labeling:
 The container should not interact physically or chemically with the
chemical placed in it
 The container should be
– Light sensitive container: which does not transmit more than 18% of UV
radiant energy falling up on it.
– Well-closed container: protects contents from extraneous solids and from
loss of drug under ambient conditions.
– Tightly closed container: protects contents from contamination by
extraneous liquids solids or vapors or from loss of drug due to evaporation.
– Tamper –Evident Packing, airtight container, Single–dose container etc

33. The compendia (cont…)
 Storage conditions
 Cold: any TO not exceeding 8O
C and usually between 2O and 8O
C.
 Cool: Any TO between 8O and 25O
C.
 Room Temperature: TO prevailing in working area
 Warm: Any TO between 20O and 40O
C.
 Excessive heat: Any To above 40O
C.
 Where no specific conditions are indicated it is to be understood that
storage conditions includes protection from moisture, freezing and
excessive heat.

34. The compendia (cont…)
 Other provisions applied to general chapters and monographs
 Quantities
 Apparatus and procedures
 Drying and ignition to constant mass
 Reagents
 Solvents
 Expression of content
 Temperature
 Abbreviation and symbols
 Units of the international system (SI) used in the pharmacopoeia and
equivalence with other units

35. The compendia (cont…)
b) Monograph:
 A detailed and documented article on a particular subject.
 a statement that specifies
 the kinds and amounts of ingredients a drug or class of drugs may contain,
 the directions for the drug's use,
 the conditions in which it may be used, and the contraindications to its use.
 It also defines qualitative and quantitative characteristics with the test
procedures and their acceptance limits.

36. The compendia (cont…)
 Official monograph generally is both descriptive and informative: includes the
following
1. Title : generic name, molecular structure, formula and weights are given,
Chemical names have also been provided
2. Therapeutic category
3. a description of its physical characteristics
4. a statement of the minimum standard of purity as determined by the
assay
5. Identification tests for use in verifying the identity of the product
6. limit tests to exclude excessive contamination and /or decomposition

37. The compendia (cont…)
7. Assay method: official quantitative procedures for determination of the
active ingredient, solvents and other constituents require to asses
compliance with the standard
8. physical constants and tests which supplement the standard
9. other information on:
 packaging and storage conditions
 labeling and other regulatory requirements
 Dosage
 cautionary notices on cytotoxic and other such dangerous materials

41. General tests
 Contain information basic test procedures which are needed as general
requirements to be tested for the generalized dosage form (tablet, injection,
capsules, suppositories, etc.). It includes
 Apparatus for tests and assay
 Physical tests and determinations : - Disintegration, Dissolution, Color, Loss
on drying, Refractive index, Optical rotation
 Chemical tests and assays : - Identification tests, Limit tests and assays
- Nitrogen determination, Water determination
- Vitamins assay
The compendia (cont…)

42. The compendia (cont…)
 Microbial tests
 Antimicrobial preservative effectiveness tests
 Microbial limit tests
 Biological tests and assays
o Antibiotic assay
o Bacterial endotoxin tests
o Bacterial reactivity tests
LIMIT TESTS
 The substances that are used in pharmaceutical field should be almost pure
so that they can be used safely.

43. The compendia (cont…)
 It is almost impossible to get an absolutely pure material as impurities get
incorporated in to them either during manufacture, purification or storage
 The total impurities should be in certain minimal range, i.e. there should be
acceptance criteria for specified impurities.
 In general, specification limit not more than 0.1% for any unspecified
impurity should be included.
 Limit tests are designed to identify and control small quantities of impurity
which are likely to be present in the substance

44. The compendia (cont…)
 Sources of Impurities in Drug Products
1. Raw materials used in the manufacture
2. Method or the process used by the manufacturer
 Reagents, Solvents, Reaction vessels, Catalysts used in the process,
3. Due to the instability of the product
4. From atmospheric contaminates:- dust(aluminum oxide, silica, sulfur, soot,
etc), sulfur dioxide, hydrogen sulfides, arsenic
5. Manufacturing hazards
-microbial contamination, packing errors,
6. Storage conditions- Temperature effects, Physical changes

45. The Law and pharmaceutical analysis
Law – is the body of principles that govern conduct and observance of which can be
enforced in courts.
 It can distinguish what is permissible from what is not.
FDA, Food and Drug Adminstration, FDA overview
 FDA is an agency of the United States Department of Health and Human Services and is
responsible for:
 Regulating the safety and effectiveness of:
 drug and food (humans and animal), vaccines, ,
 medical devices (human and animal) and radiation emitting devices (including
non-medical devices)
 Regulating biologics, and blood products.

46. Authorization and mandate
 The FDA derives its authority and jurisdiction from various Congressional acts.
 The main source of the FDA's authority is the Federal Food, Drug, and Cosmetic
Act.
 The main purpose of the FDA is to protect citizens from products that are
inherently unsafe
 Regulations may take several forms, including but not limited to outright ban,
controlled distribution, and controlled marketing
 Additionally, the FDA sets the standards under which individuals may be
licensed to prescribe and dispense drugs or other medical devices.
The Law and pharmaceutical…….

47. The Organization Components
 Currently, the FDA is divided into five major Centers, each with its own
origins and history:
 The Center for Drug Evaluation and Research (CDER)
 The Center for Biologics Evaluation and Research (CBER)
 The Center for Devices and Radiological Health (CDRH)
 The Center for Food Safety and Applied Nutrition (CFSAN)
 The Center for Veterinary Medicine (CVM)
CDER operations
 regulates human pharmaceuticals
 approves new drugs
 determine whether new drugs are unsafe or present risks not
disclosed in the product's labeling
The Law and pharmaceutical…….

48. The drug approval process
 The FDA is charged with the task of approving or rejecting drugs that
pharmaceutical companies want to market.
 The FDA ensures that newly approved drugs have passed vigorous testing,
which includes:
 animal testing
 clinical trials of healthy individuals, and
 clinical trials of individuals suffering from the disease the drug is meant
to treat.
 The FDA also verifies safety, quality, efficacy, along with drug interactions,
and how various drugs may work depending on age and sex.
The Law and pharmaceutical…….

49. Food, Medicine and Health care Administration and Control Authority of
Ethiopia (FMHACA)…currently called”EFDA‖
 FDHACA of Ethiopia is a federal agency established by Proclamation No.
661/2009.
Mission
 To promote and protect public health by ensuring the safety, efficacy, and
quality as well as the proper use of the drugs
 FDHACA of Ethiopia has four major Departments:
1. Food, Drug Evaluation and Registration Department (DERD)
2. Planning, Drug Information Establishment and Distribution Department (PDIEDD)
3. Drug Control and Abuse Prevention Department (DCAPD)
4. Drug Quality Control and Toxicology Laboratory Department (DQCTLD)
The Law and pharmaceutical…….

50. Scope of Control
 Products Controlled by FMHACA (EFDA‖)
 Human drugs
 Radio-pharmaceuticals
 Traditional medicines
 Pesticides
 Medical supplies and instruments
 Sanitary items
 Cosmetics
 Raw and packaging materials
 Food and food products

51.  Institutions Controlled by FMHACA…currently ―EFDA‖
 Manufacturers
 Importers and/wholesalers
 Exporters
 Retail-outlets
 Drug quality control Labs
 Scientific offices,
 Commission agents
 Health institutions

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