B.Pharm. III (SEM.VI) PCI syllabus Unit I QA and QC concept

1. Quality Assurance
and
Quality management
concepts
B.Pharm. III (Sem.VI)
Ms. P.G. Swami
PI

2. • Before moving towards the concept of quality control and Quality
assurance, firstly try to understand the concept of ‘Quality’
• The regulatory bodies all around the world have accepted that a
pharmaceutical product which meets the following five
characteristics can be accepted as a quality product.
• Identity
• Strength
• Safety
• Purity and
• Efficacy

3. Definition of Quality :
• Quality is defined in some dictionaries as “DEGREE OF
EXCELLENCE”, while the International Organization for
Standardization (ISO) defines it as “The totality of features and
characteristics of product of service that beer on its ability to satisfy
stated or implied needs”
Definition of Quality Control:
Definition of Q.C by WHO
“QC is a part of GMP which is concerned with sampling,
specification, testing with the organization, documentation and
release procedure which ensure that the necessary and relevant tests
are actually carried out and that materials are neither release for use
nor product release for sale or supply until their quality has been
found satisfactory”.

4. Definition of QC by MCC South Africa
• “Q.C is the part of GMP which is concerned with the organization,
documentation and release procedures which ensure that necessary and
relevant test are actually carried out that materials are neither released
for use, nor products released for sale or supply, until their quality has
been check and judge to be satisfactory”.

6. Concept of Quality Control:
Quality control:
❖QC just set of activities for ensuring quality in products, the
activities focus on identifying defects in actual product produced.
❖QC is a corrective tool.
❖QC aims to identify defects in finish product and the aim of QC is
to identify defects after a product is developed and before it is
released.
❖QC works by finding an eliminating sources of quality problems
through tools and equipment so to meet customer’s requirement.

7. Quality control

10. Quality control system should ensure that
• There should be adequate facilities, trained personnel and approved
procedure are available for sampling, inspecting and testing raw materials,
packaging material, intermediate product, bulk and finish products and
where appropriate for monitoring environment and conditions for GMP
purposes.
• Samples of starting materials, packaging materials, intermediate products,
bulk products and finish products should we taken by personnel according
to the methods approved by Quality Control.
• Test methods should be validated.
• Record should be made manually and /or by recording instruments which
demonstrate that all the required samplings, inspecting and testing
procedures where actually carried out. Any deviations are fully recorded and
investigated.
• The finish product containing the active ingredients should comply with the
Qualitative and Quantitative composition of marketing authorization and
should be the purity required, and should be enclosed within their proper
containers and correctly labeled.

11. • All records containing results of inspections and that testing of
materials, intermediate bulk and finish product should be formally
assessed against specification.
• Product assessment should include a review and evaluation of
relevant production documentation and an assessment of deviations
from specified procedures.
• No batch of products should be released for sale and supply prior to
certification by an authorized person that it is in accordance with the
requirement of the relevant authorizations.
• Sufficient reference samples of starting materials and products
should be written to permit future examination of the product is
necessary and that the product is written in its final pack unless
exceptionally large packs are produced

12. Responsibilities of QC department
• QC is responsible for day -to- day control of quality within the
company.
• QC department is responsible for analytical testing of incoming raw
materials and inspection of packaging components including labeling.
• To conduct in process testing when required, perform the
environmental monitoring and inspect operations for compliance.
• They also conduct the required tests on finished dosage form.
• QC plays a major role in the selection of qualified vendors from
whom raw materials are purchased.
• The environment areas for manufacturing of various dose forms are
tested and inspected by the QC department.
• Maintenance of all documents related to the QC department.

13. Definition of Quality Assurance:
Definition of Q.A by WHO
“Quality assurance is a wide ranging concept covering all matters that
individually and collectively influence the quality of product.
Definition of QA by MCC South Africa
“QA is the sum total of organized arrangement made with the objective
of ensuring that medicines are of quality required for their intended use.
It is thus a wide ranging concept, cover all matters affecting quality.”
Definition of QA by ISO 9000
“QA is the part of quality management focused on providing confidence
that the quality requirement will be fulfilled.”
Thus, QA is a systematic process to ensure whether a product or service
will fulfill its intended quality and desire requirements will be met.

14. Concept of Quality Assurance
• Quality assurance is a set of activities for ensuring quality in the
process by which the products are developed.
• QA is a managerial tool.
• QA aims to prevent defects with a focus on process used to make the
product.
• The goal of QA is to improve development and test processes so that
defects do not rise when the product is being developed.

15. Quality insurance system should ensure that
• Medicinal products are design and developed in a way that takes
account of the requirement of the good manufacturing practices.
• Production and quality operations are clearly specified and GMP
adopted.
• Managerial responsibilities are clearly specified.
• Arrangements are made for manufacture, supply and use of correct
starting and packaging material.
• All necessary controls on intermediate products and any other in
process controls and validations are carried out.
• The finished product is correctly processed and checked, according to
the define procedures.
• Medicinal products are not sold or supplied before and authorized
person has certified that each production batch has been produced
and control in accordance with the requirement of the marketing
authorization and any other regulations relevant to the production,
control and release of medicinal product.

16. • Satisfactory arrangements exist to ensure, as far as possible, that
the medicinal products are stored, distributed and subsequently
handled so that quality is maintained throughout their shelf-life.
• There is a procedure for self inspection and/or quality audit,
which regularly appraises the effectiveness and applicability of
the QA system.

17. Responsibilities of QA department
• QA department is responsible for ensuring that the quality policies
adopted by the company are followed to meet the quality requirement.
• To identify and prepare the necessary SOP's related to the control of
quality.
• QA department ensure that product meets all the applicable
specification and that it was manufactured according to the standards
of GMP.
• QA also hold responsibility for quality monitoring or audit.
• QA functions to access operations continually and to advise and guide
with them towards full compliance with all applicable internal and
external regulations.

18. QUALITYASSURANCE VS QUALITY CONTROL