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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

o School & Education Restaurants &

o Food Hotels &
o Accommodation
o Clothes and dresses
o selection Cars & Vehicles Repairs &
o Maintenance Household Appliances & Furniture

2 Quality in the Healthcare Field

o Targets (customers) of the healthcare team:
• The Patient
• The Community
o 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
o Part of GMP concerned with
o sampling,
o specification & testing,
o documentation &
o release procedures which ensure that
o the necessary & relevant tests are performed &
o the product is released for use only
o after ascertaining it’s quality in every aspect

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QA is company Base
• All those planned actions necessary to
provide adequate confidence that a
product will satisfy the requirements for
quality, includes implementation of
cGMP, personnel control.
QC is Lab based
• 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 Management of Quality?

The aspect of management /functions that

 determines & implements

 the “quality of 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

o adequately resourced with:

o Competent personnel
o Suitable &
o sufficient premises,
o equipment &
o 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.

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.