Quality Assurance
and Quality
Management
Kajal Baviskar
Dept. of Pharm. Chemistry
K.K.Wagh College of Pharmacy
of Pharmacy
Quality assurance and quality management concepts
Quality Assurance
Quality Control
GMP
◎ Quality should be built into the product and
testing alone cannot be relied onto ensure
product quality.
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◎ Quality management is the act of overseeing all
activities and tasks that must be accomplished to
maintain a desired level of excellence.
◎ This includes the determination of a quality 5
policy, creating and implementing
quality planning and assurance, and quality
control and quality improvement
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Umbrella of Quality
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Quality Assurance
Quality assurance (QA) is a way of preventing
mistakes and defects in manufactured products and
avoiding problems when delivering products or
services to customers.
According to WHO, quality assurance is a wide-
ranging concept covering all matters that
individually or collectively influence the quality
of a product. It is totality of the arrangement
made with the object of ensuring that
pharmaceutical products are of quality required
for their intended use.
◎ Q.A deals with all matters related to quality of
product.
◎ Quality of the medicine /product must meet the
requirements of the intended use or as an
required by the ultimate/end user. 12
◎ It is wide ranging concept covering many aspects
which are outside the scope of Q.C./GMP etc.
◎ It is sum total of organized arrangement made
for producing a quality product.
A pharmaceutical product which meets following 5
characteristics can be accepted as a quality product.
Identity
Strength 14
Safety
Purity
Efficacy
◎ Name and content
Identity
◎ If you call name of the product it will refer to a specific
product only containing specific ingredients.
Issues:
Product with same name but different formulations.
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Product with same name but different API
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Therefore product identity may be referred as:
Name of the product
Type of formulation
Name and quantity of API in a unit dose.
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Strength ◎ Strength of pharmaceutical unit dose.
◎ “ each tablet contains 500 mg paracetamol”
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◎ i.e. safety of the ultimate user or patient.
Safety
When a patient takes drug, he may experience any one of
the foolowing:
1. He gets no desired effect.
2. He gets partial desired effect
3. He gets unexpected, undesired effect (unknown side 19
effects)
4. He gets expected undesired effect (known side
effects)
5. He gets desired effect.
A product which gives both 4th and 5th or only 5th effect
may be considered as safe product.
Purity ◎ Product is free from any cross contamination..
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Wide ranging concept??
◎ Pre production activities: procurement of
materials, storage etc.
◎ Production and Q.C activities.
◎ Post production activities: distribution and
storage
◎ Also activities carried out and all decision taken
by people at various levels and various times
which have effect on the quality of product.
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Ultimate User??
Ailing person/Patient
Interests of user:
Effective medicine/ reliability of results
Reasonable price
Easy availability.
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Sum total of organized efforts??
All efforts should have contribution to the quality of
product.
No duplication of effort.
Activities should be value adding and not cost
adding.
Activities of QA ◎ Products are designed and developed taking into
account GMP, GLP, GCP etc.
◎ SOP should be maintained.
◎ Calibrations and validations to be carried out time
to time. 27
◎ Finished products are correctly processed and
checked.
◎ Products not to be sold or supplied before
certification.
◎ Self inspection/Quality audit
Responsibilities ◎ Ensuring quality policies adopted by the industry
of QA dept. are followed.
◎ Products meets all the specifications and GMP are
followed.
◎ Audits 28
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◎ GMP is a part of Quality Assurance which ensures
that products are consistently produced and
controlled to the quality standards appropriate to
their intended use and as required by marketing
authorisation.
◎ GMP is a part of Q.A
◎ Main function is to produce quality products
consistently
◎ GMP must deal with both production and Q.C
related issues 31
Activities of ◎ All manufacturing process be clearly defined.
GMP ◎ Critical steps of manufacturing process and any
significant changes made to the process
validated.
◎ All necessary facilities to be provided. 32
◎ Training of operators
◎ Records to be maintained
◎ Proper storage and distribution
◎ System to recall any batch as and when required.
Quality control 33
Definition ◎ Q.C is a part of GMP concerned with sampling,
specifications, testing with the organization,
documentation and release procedures which
ensure that necessary and relevant test are
actually carried out and that materials are neither
released for use nor products release for sale or
supply.
◎ QC labs
◎ Sampling
◎ Retained samples
◎ Records
◎ Validation 35
Q. C labs ◎ Chemical testing laboratory
◎ Instrumental Analysis lab
◎ Microbiology and toxicology lab
◎ Provision for retained samples
◎ Documentation room 36
◎ Books
◎ Trained personnel
◎ SOP’s
Sampling
Sampling area
Sampling of sterile products
Sampling procedure
Reference samples 37
Sampling of I.P.Q.C materials
Sampling of bulk finished and packed materials.
◎ Sampling area
Separate sampling area
Poisons/explosives
Packaging material
◎ Sampling of sterile pdts
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Aseptic area
Sterile equipments
◎ Sampling procedure
Representative samples
Containers to be marked
Clean equipment
Containers to be opened, sampled, and resealed to 39
prevent contamination
Sample a component from the top, middle, and
bottom of its container
* Not to be composited
Containers should bear
Name of material
Batch/lot no.
Number of contaibner from which sample has been
taken 40
Sign of person
Date
Containers from which samples have been taken
should be marked.
◎ Reference samples:
Sm/fp which can be stored for future anlaysis if the
need arises during shelf life of the batch concerned.
◎ Retained samples: 41
Samples collected from batch for referring packing
style, batch no., mfg date, exp date, patient leaflets
or other info.
◎ In some cases, retained samples may be skipped.
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Each lot of very API to be stored in qs to carry out all
tests to be retained for 3 months after date of expiry
of last batch produced from that active ing.
Samples of finished formulations to be stored in
same/simulated containers in which drug has been 43
actually marketed.
◎ As per WHO
Retained samples: 1 year after expiry date
FP final packaging
If exceptionally large packages: smaller samples
may be stored. 44
API samples should be retained for 1 year beyond
expiry.
Other : minimum of 2 years
Size of retention samples: permit atleast 2 full
examinations.
◎ Sampling of IPQC materials:
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Monitor the progress of manufacturing process
If necessary, adaptation of manufacturing processes
to ensure that the product confirms to its 45
specifications.
Control of equipment
Control of env.
Performed
during a processing step
or
After end of process
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“ identify and follow all the changes that may occur
during applied technological procedures.
Thank you
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