This document outlines the role of quality systems and audits in pharmaceutical manufacturing, detailing regulations, management responsibilities, and the importance of a coordinated quality management approach. It emphasizes the commitment of top management to quality, resource management, and objectives based on the SMART framework. Additionally, it addresses the preparation and execution of quality audits, corrective actions, and continuous improvement measures within the quality management system.

1. Role of Quality System and Audit in
Pharmaceutical
Manufacturing environment

2. CONTENTS
Introduction
Quality System Approach
Management Responsibilities
Resources
Reference

3. Introduction
• This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
• The QA audit are also described, including preparation, key items
interest, a typical checklist of the audit itself, corrective and prevent
actions following the audit, and suggested measures for assuring
successful operation of the unit.

4. QUALITY
ASSURANC
E
QUALITY
SYSTEM
QUALITY
UNIT
QUALITY
MANAGEME
NT
QUALITY
CONTROL
FDA guidance on the quality systems approach
(pharmaceutical QS guidance)

5. Quality System Approach
•Involves a coordinated approach to the management of qualify
related activities as processes that work in conjunction with
one another to provide assurance that the product meets its
specified requirements.
It involves:
 A management commitment to quality that is communicated
throughout the organization.
 Identifying quality requirements using risk management and
other methods as appropriate
 Developing a quality policy, plan, objectives.
 Establishing an organizational structure with identified
responsibilities and authorities that allows quality objectives
to be met.

6.  Providing the resources needed to meet quality objectives
 Developing the required systems and processes
 Establishing methods for the ongoing objectives evaluation of
the performance of systems and processes including quality
auditing
 Initiating corrective and preventive actions as needed to
assure that quality objectives are consistently and reliably
met.
• The use of risk management techniques
 Identifying product requirements
 Establishing processes and process control and monitoring
methods
 Evaluating quality data, identifying appropriate corrective &
preventive actions to address quality problems.
 and for other quality related activities can increase the overall
efficiency and effectiveness of the quality system,

7. Quality systems approach
overview
Management
CAPA
Production
&amp
;amp;
Process
Control
Records,
Documents,
&
amp;
Change
Controls
Design
controls
Material
Controls
Equipme
nt &
Facility
Controls

8. MANAGEMENT RESPONSIBILITIES
• Current quality system models assign management a major role in the
deployment and operation of the successful quality system. In such system,
major management responsibilities include the following:
LEADRESHIP STRUCTURE QUALITY
SYSTEM
QUALITY
POLICY
ACCOUNTABIL
ITY SYSTEM

9. 5.6: MANAGEMENT REVIEW

10. 5.1 Management Commitment
Top management shall provide evidence of its
Commitment to the development and implementation
of the QMS and continually improving its effectiveness
By:-
a) Communicating to the organization the importance
of meeting customer as well as statutory and
regulatory requirements.
b) Establishing the quality policy
c) Conducting management reviews.
d) Ensuring the availability of resources.

11. 5.2 Customer focus
Top management shall ensure that customer requiremen
are determined and are met with the aim of enhancin
customer satisfaction.

12. Quality Policy
• Top management shall ensure that the quality policy:-
a) Is appropriate to the purpose of the organization
b) Provides a framework for establishing and reviewing quality
objectives
c) Is communicated and understood within the organization
d) Is reviewed for continuing suitability.

13. Quality Objectives
• Shall follow SMART Rules:
-Specific
-Measurable
-Attainable
-Relevent
-Time-framed

14. 5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and
Authorities are defined and communicated within the
Organization.

15. Internal Communication
Top management shall ensure that appropriate communication
processes are established within the organization and that
communication takes place regarding the effectiveness of
the quality management system.

16. Review input
Review shall include information on :-
a) Results of audits,
b) Customer feedback,
c) Process performance and product conformity,
d) Status of CAPA,
e) Follow-up actions from previous management reviews,
f) Recommendations for improvement.

17. Review output
• The output from the management review shall include any
decisions and actions related to………
a) Improvement of the effectiveness of the quality
b) Improvement of product related to customer requirements,
c) Resource needs

18. Resources
The major resources used by organizations are often
described as follow:
1. Human Resources
2. Financial Resources
3. Physical Resources
4. Information resources
Managers are responsible for acquiring and managing
the resources to accomplish goals.

19. Human Resources
 Ensuring adequacy particularly in respect of training
 Infrastructure
 Building, work space, equipment, vehicles, information systems etc.
 Environmental controls ( Aligned with ISO14000)
Financial Resources
The resources from which the enterprises obtain the funds
They need to finance their investments, capital and current
Activites.
E.g. Cash, Bank deposits etc.

20. Physical Resources
The physical resources of a business include all the
tangible resources owned and used by a company such
as Land, manufacturing equipment and office equipment.
Land, building, water and water right .
Machinery and manufacturing equipments.
Vehicles and distribution networks.
Information resources
It is the planning, budgeting, organizing, directing, training
and control associated with an organization’s information
The term encompasses both information itself and the

21. Reference
•Siegel E.B.; Barquest J.M.; et al, Pharmaceutical
Manufacturing Handbook, John Wiley Publication
Pg. No. 202 – 212
• Kaur J. Quality audit: Introduction, types and procedure.
Pharma Pathway; 2017. Available from: http://pharmapathway
.com/quality-audit-introductiontypes-and-procedure/.