Quality Assurance and Quality Control
Session 21: Quality Assurance and Quality Control
Total Session Time: 120 minutes
Pre-requisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |05 minutes |Presentation |Introduction, Learning Tasks |
|2 |20 minutes |Presentation |Quality Assurance in Pharmaceutical |
| | | |Production |
|3 |15 minutes |Presentation |Quality Control in Pharmaceutical |
| | | |Production |
|4 |10 minutes |Presentation |Difference between QA and QC |
|5 |30 minutes |Presentation |Quality Variation in Pharmaceutical |
| | | |Production |
|6 |30 minutes |Presentation |Documentation in Pharmaceutical |
| | | |Production |
|7 |05 minutes |Presentation |Key Points |
|8 |05 minutes |Presentation |Evaluation |
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing
STEP 2: Quality Assurance in Pharmaceutical Production (20 minutes)
product and its ability to satisfy stated and/ or implied needs
o Quality begins with research and development
o Quality is designed and built in the product
that individually or collectively influence the quality of a product
continuously of the right quality for the intended use
confidence that quality requirements will be fulfilled
includes product design and development with special focus on process
design
o GMP is a part of QA which ensures that products are consistently
produced and controlled to the quality standards appropriate to their
intended use
o Quality relationships in a pharmaceutical industry is;
Quality Management
Quality Assurance
Good Manufacturing Practice (GMP)
Quality Control
o Research
o Development
o Prototyping
o Documentation
o Raw materials
o Facilities (buildings)
o Equipment
o Personnel and supervision
o Monitoring, feedback, follow-up
o It is a process, not an end point
o It must be independent of financial pressures
o Must ensure that quality policies are followed
o Must have final authority in product acceptance, rejection and release
to public
o Must be an integral part in production
o Must be responsible for day-to-day operations and for longer term goal
settings
o QA department is responsible for ensuring that the quality policies
adopted by the company are followed
o Helps to identify and prepare the necessary SOPs relative to the
control of quality
o It must determine that the products meet all the applicable
specifications and that it was manufactured according to the internal
standards of GMP
o QA is responsible for quality monitoring or audit function
o QA functions to assess operations continually and to advise and guide
them towards full compliance with all applicable internal and external
regulations
o Ensures that proper documentation is followed
comply
o Quality control (analytical testing of products)
o Raw materials control (sampling, inspecting and testing of incoming
raw materials)
o Packaging and labelling components (bottles, foils, labels, measures,
cartons)
o Physical inspection of product and operations at critical intermediate
stages
o Management of internal audit system
o Handle customers’ feedback and satisfaction
o Management of deviations, incidents and investigations
o Management of GMP training system
o Management of validation system
STEP 3: Quality Control in Pharmaceutical Production (15 minutes)
specification and testing, documentation and release procedures which
ensure that the necessary and relevant tests are performed and the
product is released for use only after ascertaining its quality
requirements
o QC department is responsible for day-to-day control of quality within
the company
o QC plays major role in selection of qualified vendors from whom raw
materials are purchased
and degree of compliance with GMPs prior to being approved
o QC is responsible for analytical testing of incoming raw materials
(e.g. assay, titrations etc)
o QC is responsible for analytical testing and inspection of packaging
components, including labelling (e.g. appearance, spectroscopy, loss
on drying etc)
o QC is responsible for conducting in-process testing when required,
perform environmental monitoring, and inspect operations for
compliance
o QC is responsible for conducting required tests on finished products
or dosage forms (e.g. assay, dissolution, content uniformity etc)
o Environmental areas for manufacturing of various dosage forms are
tested and inspected by QC department
o Generally QC is responsible for efficacy, safety, quality and
compliance in pharmaceutical manufacturing
o To establish quality standards
o To locate quality deviation
o To evaluate methods and processes
o Quick sale of quality products
o Production of standard quality products
o Improvement of quality
➢ Devising the control over raw materials
➢ Fixing standards and specifications
➢ Exercising control over production operation
➢ Locating inspection point
➢ Maintaining quality of equipment
➢ Maintaining records
o Improves quality of production and reduction in product cost
o Uniformity in the production and supply of standard quality to
consumers
o Offering full return of the price paid the consumers and giving
convenience and satisfaction to customers
o Reduction in spoiled production and rejection from consumers and
dealers
o Promotion of exports due to superior and standard quality production
o Reduction in inspection cost
o Making products popular in markets
STEP 4: Difference between QA and QC (10 minutes)
summarised in the table bellow
|Quality Assurance (QA) |Quality Control (QC) |
|A set of activities for ensuring|A set of activities for ensuring |
|quality in the process by which |quality in the products. |
|products are developed | |
|It is a managerial tool |It is a corrective tool |
|Aims to prevent defects (a |Aims to identify defects in |
|proactive process) |finished products (a reactive |
| |process) |
|The goal is to improve |The goal is to identify defects |
|development and test processes |after product is developed and |
|so that defects do not arise |before it is released for use |
|when product is being developed | |
|Prevents quality problems |Activities or techniques are used|
|through planned and systematic |to achieve and maintain product |
|activities including |quality, process and services |
|documentation | |
|Establishes quality management |Finds and eliminates sources of |
|system |quality problems to meet |
| |customers’ requirements |
|It is the responsibility of |It is the responsibility of a |
|everyone in the team involved in|specific team that tests the |
|production of the product |product for defects |
|Verification is an example of QA|Validation is an example of QC |
STEP 5: Quality Variation in Pharmaceutical Production (30 minutes)
whole process i.e. from reception of raw materials to the final product
in its package
o Raw materials
o Methods
o Machines
o Personnel
o Raw materials control
o Raw materials for pharmaceutical production are classified into two
broad groups;
Ingredients)
o To control quality variation contributed by raw materials;
materials, printed labelling materials) are received from suppliers
the receipt, testing and storage of all raw materials i.e. a good
raw material specifications must be written in precise terminology,
complete and provide specific details of test methods, type of
instruments and manner of sampling
excipients: proper container, labels, lot number, expiry date etc;
for packaging materials: colour of label, weight of label, carton,
damage etc) received materials are kept (properly arranged) in a
definite area
procedures and sent to the quality control laboratory for testing
according to written procedures
material to perform all required tests for the raw material (these
preservation samples are kept for at least 7 years or as otherwise
specified)
is accepted and moved to the release storage area
is used first
and sent back to the supplier
[pic][pic] Refer students to Handout 21.1: Raw Material Quality
Assurance Monograph for further reading
o Control of manufacturing practices
Personnel control
departments i.e. production, packing, labelling etc.
monitored by highly trained and experienced persons
mistakes so that to avoid serious loss or compromise in quality
Equipment and building control
location
non-additive
is easy to replace, easy to clean, and easy to operate and empty
liquid sections should be separated completely
Control of records
production record)
Production procedure control
rules from reception of raw materials up to delivery of final
product
their quantities) is delivered to the production department
and equipment to used and precautions to be taken etc
batch are weighed/measured and delivered to in-process quality
control laboratory (under the quality control department)
responsible for the production procedure control
Packaging control
product
packed in recommended containers and not otherwise
writing of batch numbers etc
distribution of the product
Distribution control
reference)
the same packs as they are marketed
materials for any purpose or necessary demand
STEP 6: Documentation in Pharmaceutical Production (30 minutes)
pharmaceutical manufacturing
o Defines specifications and procedures for all materials and methods of
manufacture and control
o Ensures all personnel know what to do and when to do it
o Ensures that authorized persons have all information necessary for
release of products
o Ensures documented evidence, traceability, provide records and audit
trail for investigation
o Ensures availability of data for validation, review and statistical
analysis
manufacturing, Good Documentation Practice (GDP) is required
storing and retrieval and review of any document
o Facilitates compliance with GMP and regulatory authorities
o Define manufacturers’ system of information and control
o Minimize risks of misinterpretation and errors caused by oral or
casually written communications
o Provide unambiguous procedures to be followed to provide confirmation
of performance
o Allow calculations to be checked and approved
o Allow tracing of batch history
o Ensure quality of product
consistent, indelible(isiyofutika), legible(readable), timely, direct,
authentic(real,original) and authorized
o Site Master File (SMF)
pharmaceutical industry (plant)
activities, name and address, type of products, description of
employees, external technical support and daily management
system
training, health requirements and personnel hygiene clothing
finish, brief description of ventilation, special areas, water
system, maintenance of premises, major production and laboratory
equipments, maintenances of equipments, calibrations and
sanitizations
documents
handling of materials, handling of rejected materials and
products, brief description of general policy of process
validation
Control (QC)
implementation of any change in validated system, equipment,
process and materials
and defining acceptance criteria
o Specifications
or obtained during manufacture have to conform
excipients)
o SOPs
o Test Methods
o Lists
o Certificates of analysis
of acceptance or rejection of products
o Labels
o Organograms
o Job description
o Master Formula Record (MFR)
starting materials with their quantities and packaging materials,
together with a description of the procedures and precautions
required to produce a specific quantity of a finished product as
well as the processing instructions including the in-process
controls.
Production Record
for the product
Manufacturing Record (BMR) or Batch Production Record (BPR) by
manufacturing units
be manufactured (It ensures consistency in production of each
batch)
Contents of MFR
strength
product stores
manufacturing process with their capacity
process and packing (also included in the BMR)
active material
compression and coating should be written in detail including
the process time and yield
humidity and storage conditions for every step
containers, labels, packaging)
materials should be included in the details
batch
o Batch Production Record (BPR)
a product
expiry date, batch number, code number)
equipment
and tertiary packing materials
procedure, specifications and precautions followed
o All documents should be carefully and logically specified to prevent
wrong uses
o Information must be clear and easy to understand
o Each document should include;
STEP 7: Key Points (5 minutes)
that individually or collectively influence the quality of a product. It
is a totality of the arrangements to ensure that the drug is continuously
of the right quality for the intended use
includes product design and development with special focus on process
design
specification and testing, documentation and release procedures which
ensure that the necessary and relevant tests are performed and the
product is released for use only after ascertaining its quality
requirements
whole process i.e. from reception of raw materials to the final product
in its package
pharmaceutical manufacturing
manufacturing, Good Documentation Practice (GDP) is required
storing and retrieval and review of any document
STEP 8: Evaluation (5 minutes)
References
Aulton M.E & Kevin M.G, (Eds): (2013) Pharmaceutics: The design and
manufacture of medicines, (4th ed.) Churchill Livingstone
Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.), Willey-
Blackwel publications
Gennaro, R. A, et al. (Eds) (1995) Remington: The Science and Practice of
Pharmacy, Volume I & II, (19th ed.): Mack Publishing Company, Easton,
Pennsylvania 18042
Liebsch, B et al (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam
University Press.
Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice
of Pharmaceutics (12th ed.): The Pharmaceutical Press, London
Polderman, J., (1990) Introduction to Pharmaceutical Production: Novib, The
Hague
Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, 8th Ed.
Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)
Manual for Decentralized Infusion Production, Infusion Unit Project
Tanzania
Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,
Colorado.
Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production
and processes, John Wiley & Sons
Watson, D. G., (1999) Pharmaceutical Analysis: A Textbook for Pharmacy
Students and Pharmaceutical Chemists: Churchill Livingstone,
Edinburgh.
|[pic] |Handout 21.1: Raw Material Quality Assurance Monograph |
1. Structural formula, Molecular weight
2. Chemical name(s)
3. Item number
4. Date of issue
5. Date of superseded, if any, or new material
6. Signature of writer
7. Signature of approval
1. Safety requirement
2. Sample plan and procedure
3. Sample size and sample container to be used
4. Preservation sample required
1. Retesting schedule
2. Re-analysis to be performed to ensure identity, strength, quality
and purity
1. Description
2. Solubility
3. Identity
a. Specific chemical test such as related alkaloids, organic
nitrogen basis, acid moiety or inorganic salts tests (sulphate,
chloride, phosphate, sodium and potassium tests or other spot
organic and inorganic chemical test as needed
b. Infrared absorption
e. Congealing point
f. Boling point or range
4. Purity and Quality
a. General completeness of solutions (pH, specific rotation, non-
volatile residue, ash, acid insoluble ash, residual on ignition,
loss on drying, water content, heavy metals (arsenic, lead,
mercury), sulphate, chloride, carbonate, acid value, iodine
value, saponification value)
b. Special quality tests (particle size, crystallinity
characteristics and polymorphic forms)
aldehydes in ether and related degradation products
5. Assay, calculated either on non-hydrous or hydrous basis
6. Microbial limits (especially for raw materials from natural
sources)
1. Compendia tests (USP, BP or NF references
2. Non compendia tests (detailed analytical procedure, weights,
dilutions, extractions, normality, reagents, instrumentation used
and procedure if any, calculations)
1. List of prime suppliers and other approved alternative suppliers,
if any
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