Quality Assurance, GMP and Quality Control

1 What is Quality?
It is the best
possible expected outcome
of an effort
under given conditions
and terms of
skill, experience,
financial and
available resources.
e-g: Customer Satisfaction Daily Practice of Quality School & Education Restaurants & Food Hotels &
Accommodation Clothes and dresses selection Cars & Vehicles Repairs & Maintenance Household
Appliances & Furniture

2 Quality in the Healthcare Field

Targets (customers) of the healthcare team:
• The Patient
• The Community
The aim of the healthcare team:
• To provide quality patient care
• To provide quality health service to the community

3 Quality in Pharmaceutical industry

4 Quality Assurance
It is the sum total of the organized arrangements
with the objective of ensuring
that products will be of the quality required
for their intended use

5 Good Manufacturing Practice

Is that part of QA
aimed at ensuring
 that products are
consistently manufactured
to a quality appropriate
to their intended use

6 Quality Control
Part of GMP concerned with sampling,
specification &
testing, documentation &
release procedures
which ensure that
the necessary & relevant tests
are performed &
the product is released
for use only after ascertaining it’s quality

QA is company Base QC is Lab based

• All those planned actions necessary to
provide adequate confidence that a
product will satisfy the requirements for
quality, includes implementation of
cGMP, personnel control.
• Operational laboratory techniques and
activities used to fulfill the requirements
for that a product will satisfy the
requirements quality

• Quality of process • Quality of product

• QA is company Base • QC is Lab based

• Improving the process and prevents • Finding defects and then fixing them
defects

• Receive Complaints from Market • Test and correct the complaints

9 What is Quality Management?

The aspect of management function
that determines & implements
the “quality policy”
The overall intention &
direction regarding quality,
as formally expressed & authorized by top management

10 BASIC PRINCIPLE OF QUALITY MANAGEMENT


>To achieve the reliable, quality, objective,
there should be a comprehensive QA system incorporating GMP.
>The QA system should be fully documented &
its effectiveness should be monitored.
> Manufacturer should comply with
any applicable regulations pertaining
to your specific country.
> The attainment of this quality objective
should be led by the
senior management
& requires the participation and
commitment by staff,
by the company’s suppliers
and distributors.

11 QUALITY ASSURANCE
•
  QA covers all matters which
 individually or collectively
 influence the quality of a product.
All parts of QA system should
 be adequately resourced with:
>
 Competent personnel Suitable & sufficient premises,
 equipment & facilities

12 Objective of Quality Assurance (QA)

 The overall objective of the QA is
 to ensure that each product leaving
 the plant for consumer
 distribution has met
 every recommendation of the cGMP

13 BASIC functions OF QA
> Ensure that products are designed and
developed based on sound scientific rationale and
with GMP or GLP principles being
taken into consideration.
> Ensure that managerial responsibilities
are clearly specified.
> Ensure that production and
control operations are
clearly specified and
GMP is adopted.
> Organize supply &
use of correct starting &
packaging materials.
> Ensure that finished products are
correctly processed &
checked before release.
> Ensure that products are released after
review by authorized person.
> Provide satisfactory arrangement
to ensure products are stored,
distributed & handled appropriately.
Put in place a mechanism for regular
self inspection / internal quality audit.

14 GOOD MANUFACTURING PRACTICES

Part of QA which ensures that
products are consistently produced and
controlled to the quality standards
appropriate to their intended use.
Minimize risks :
•cross contamination
•mix up
Production and
quality control functions should be
independent of each other. E.g. Cross contamination isosorbide mononitrate, dextromethorphan
All manufacturing process are
clearly defined and
systematically reviewed.

15 All necessary facilities/resources for GMP should be provided:

adequate,
qualified and
well-trained personnel
suitable premises and
sufficient space
suitable location
good personal hygiene and
proper sanitation
suitable equipment and
services

16 QUALITY CONTROL
 * QC is concerned with sampling,
specification and testing.
* Manufacturer should have a QC department.
* QC should be headed by an
appropriately qualified and
experienced person.
* QC should be independent
from production and
other departments.
* Ensure that the necessary and
relevant tests are actually carried out.
* Ensure that no materials or products
will be released for sale or
supply, until
their quality have been evaluated and
judged to be satisfactory.

17 SCOPE OF QC Items concerned:

Starting materials
Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions

18 BASIC REQUIREMENTS OF QUALITY CONTROL

 Adequate facilities,
trained personnel and
approved procedures should be available for sampling,
inspecting and testing.
 Sampling by QC personnel & testing by approved methods.

 Maintenance of QC records & failure investigation records.

 Release of batches by authorized person
Sufficient reference samples
of starting materials and
finished products

19 Quality Control Procedure

• Establish written Lab policies,
requisition forms, SOPs,
report forms, and
revision and
corrective action plan
• Specify and arrange proper standards,
chemicals and
storage
• Equipment control and
maintenance
• Train all staff and
periodic retraining
•Periodic internal audit
Sampling of raw materials
• Initially quarantined
• Sample are taken and
tested to ensure that
the materials meets strict purity guidelines
• Microbiological and
chemical testing as written in
Pharmacopeia In process check
• At intervals QC staff takes samples
to check for contamination and
ensure that the composition is as expected
• 5 tablets (every 15 minutes)
Final Product checking
All results are compiled and
recorded with name and
batch number on it.