Beruflich Dokumente
Kultur Dokumente
OF PHARMACY
Quality
Assurance &
Management
Basic Concepts And
Ideas
Anirban Saha
M.Pharm (Pharmaceutics)
Year- 1st , Semester- 2
Amity University.
Outline
o Definitions.
o Quality & Its Importance.
o Introduction.
o Characteristics of QA Programme.
o How is quality assessed and assured ?
o Quality Management And its Systems.
o Quality Assurance for Excipients.
o Quality Assurance for API.
o Quality Assurance Of Packing Materials.
o Some general tests of packing materials.
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
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Quality Management (QM)—
A quality management system is a management technique
used to communicate to employees what is required to
produce the desired quality of products and services and to
influence employee actions to complete tasks according to
the quality specifications.
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Quality is “totality of characteristics of an entity that
bear on its ability to satisfy stated and implied needs”.
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Business success may simply be the extent to which
any organization can produce a higher-quality
product or service than its competitors are able to do
at a competitive price.
When quality is the key to a company’s success,
Quality Management system allow organizations
to:
o Keep up with and meet current quality levels.
o Meet the consumer’s requirement for quality.
o Retain employees through competitive
compensation programs.
o Keep up with the latest technology.
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Introduction:
Goals of QA Programs:-
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Characteristics of a QA Program
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o Repackaging activities and dispensing practices
should maintain quality.
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o INSPECTION of raw materials and API
on arrival.
• Visual inspection
• Product specification review (including expiry dates)
• International Pharmacopoeia
• European Pharmacopoeia
• U. S. Pharmacopeia
• British Pharmacopoeia
• National Pharmacopoeia
o BIOAVAILABILITY DATA
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o Product selection
• Long shelf-life.
• Acceptable stability.
• Acceptable bioavailability.
o Selection of appropriate suppliers
• Supplier pre-qualification.
• Request samples from new suppliers.
• Request specific reports and data for certain medicines (e.g.,
bioavailability and stability studies).
• Collect and maintain information on supplier performance.
o Product certification
• GMP certificate of manufacturer.
• Product/batch certification (COA).
• Random local testing.
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How Is Quality Assured?
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Who Ensures Medicine Quality?
Hospital Pharmacy
procurement (and dispensers)
office Patients
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What Purpose Does a Quality Management System
Serve?
✔ Establishes a vision for the employees.
✔ Sets standards for employees.
✔ Builds motivation within the company.
✔ Sets goals for employees.
✔ Helps fight the resistance to change within
organizations.
✔ Helps direct the corporate culture.
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o ISO 9000 is a series of quality management systems
(QMS) standards created by the International
Organization for Standardization, a federation of 132
national standards bodies.
o The ISO 9000 QMS standards are not specific to
products or services, but apply to the processes that
create them.
o The standards are generic in nature so that they can be
used by manufacturing and service industries anywhere
in the world.
o An organization that would like to have ISO certification
needs to meet all the criteria stated in the ISO standards
and pass a detailed audit performed by an ISO auditor.
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Fundamental elements for effective
pharmaceutical quality systems are as follows:
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Management responsibility:
Leadership is essential to establish and maintain a company-wide
commitment to quality and for the performance of the pharmaceutical
quality system. Management has the responsibility to achieve quality
related goals as per the quality policy.
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Continuous improvement in process performance
and product quality:
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What Is the Need for Quality Assurance of Excipients?
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o The amount of excipients quite often exceeds the
amount of API in any given drug.
o Excipient purity is difficult to determine for many
excipients.
• –Heterogeneity of the chemical composition is
common for many excipients whereby the excipient
is still considered to be a “pure drug substance”
• –Test methods often fail to account for anywhere
near 98%, whereas we generally regard 2.0% to be
the upper limit for substances regarded as
unnecessary if not deleterious to safety or efficacy
of a drug.
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o Globalization and Cost Pressures Have Changed
the Playing Field
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Quality assurance is a wide-ranging concept that
covers all matters that individually or collectively
influence the quality of an API. It is the total of the
organized arrangements made with the objective
of ensuring that APIs are of the quality required
for their intended use. Quality assurance therefore
incorporates GMP, along with other factors that
are outside the scope of these guidelines.
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A system of quality assurance appropriate for the fabrication,
packaging, labelling, testing, distribution, importation, and
wholesale of APIs should ensure that:
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Any company that sells or distributes packaging,
packaging components, or packaged products is
responsible for compliance with state toxics in
packaging laws, regardless of where the
regulated metals originated. Based on the
experiences of regulated entities, it has become
very clear that packaging specifications and the
assurance of suppliers are not always enough to
ensure the quality of packaging materials.
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o Keep records of pack specs. agreed with
suppliers.
o Keep examples of previously supplied,
acceptable packs, for reference & comparison.
o Employ basic measuring methods to check pack
dimensions/weights/compressive strength, etc.
o Maintain close relations with pack suppliers,
exchanging & comparing QA findings.
o Have access to specialist QA & test services
with regard to particular pack materials &
problems.
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Strength tests:
-Bursting strength (Mullen; tests drop resistance).
-Edge crush (tests rigidity, stacking strength).
-Flat crush (tests compression resistance).
-Puncture (tests resistance to puncturing/shocks).
Other tests:
-Adhesion tests (adhesion of paper plies and of
liners to fluting).
-Moisture resistance (Cobb; water absorption
test).
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•Tensile test & stretch/elongation test.
•Tear test, machine & cross direction (Elmendorf
test).
•Moisture vapour transmission test.
•Gas permeability tests (oxygen, CO2, odours).
•Resistance to product, solvents, oils and
greases.
•Heat and cold (re filling temperatures, etc.);
climatic and ageing tests.
•Heat sealing strength tests.
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•Pressure testing.
•Leakage testing.
•Closure/seal testing (including closing
torque/ease of opening).
•Compression testing.
•Drop testing.
•Climatic (temperature & humidity)
testing/accelerated ageing.
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•Print rub/scuff resistance/adhesion tests.
•Resistance to product constituents/solvents.
•Registration accuracy/uniformity.
•Print definition/clarity/legibility.
•Colorimetric accuracy/consistency of tones and
shades (compared to reference colour samples).
•Resistance to fading (accelerated ageing test).
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•Compression/top load tests (empty & filled
packages).
•Leakage/seal/closure failure tests.
•Simulated transit tests with filled packages: drop
test; vibration test; inclined plane impact test;
revolving drum test; humidity and temperature
resistance tests.
•Accelerated aging tests.
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www.ncbi.nlm.nih.gov/pubmed/19289341
www.fda.gov
www.fda.gov/downloads/ICECI/ComplianceManuals/.../UCM125
420.pd
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