QMS serve many purposes, including: Improving processes Reducing waste Lowering costs Engaging staff Setting organization wide direction

1. ROLE OF QUALITY SYSTEMS AND AUDITS IN
PHARMACEUTICAL MANUFACTURING
ENVIRONMENT

2. CONTENTS
 Introduction
 Quality Audit
 Importance of Audit in Pharma Industry
 QMS (Quality Management System)
 Principles of QMS
 cGMP regulations
 Quality Assurance Function

3. INTRODUCTION
 Audit:
 Auditing is defined as the on-site verification activity, such
as inspection or examination, of a process or quality
system, to ensure compliance to requirements.
 The audit in simple terms could be defined as the
inspection of a process or a system to ensure that it meets
the requirements of its intended use.
 ISO defines the audits as “systematic, independent and
documented process for obtaining audit evidence and
evaluating them objectively to determine the degree to
which the verification criteria are met.”

4. QUALITY AUDIT
 International Standard ISO, Quality vocabulary
defined quality audit as follows:
 Quality Audit - A systematic and independent
examination to determine whether quality activities
and related results comply with planned
arrangement and whether these arrangements are
implemented effectively and are suitable to achieve
objectives.

5. IMPORTANCE OF AUDIT IN
PHARMACEUTICAL INDUSTRY
Auditing has become one of the important key for the
success of a pharmaceutical company.
1) Pharmaceutical manufacturers commonly use audits
as effective mechanism to verify compliance with
GMP.
2) Audits are intended to verify that manufacturing control
systems are operating under the state of control.
3) Audit can detect potential problems to permit timely
correction.

6. CONT......
4) To assess the effectiveness of these QA systems
and to ensure it follow GMP, self inspection and
other regulatory audits must be performed.
5) Audits can be used to establish with a high range
of confidence to remain adequate level of control
by Management.
6) Medicinal products have to be of high quality as
people lives depend on it, although end product
testing of samples from each batch is also
important, it is not enough to ensure quality which
must be built in to the manufacturing processes.

7. QUALITY MANAGEMENT SYSTEM
 Formalized system that documents processes,
procedures, and responsibilities for achieving
quality policies and objectives.
 ISO 9001:2015 Most recognized and implemented
quality management system standard in the world.
QMS serve many purposes, including:
 Improving processes
 Reducing waste
 Lowering costs
 Engaging staff
 Setting organization wide direction

8. PRINCIPLES OF QMS

9.  Customer Focus: It provides an opportunity to
understand the current and future needs of the
customers and retain their confidence.
 Leadership: Leaders can create an environment
that empowers the people to engage with the
organization and help it to achieve its quality
objectives.
 People Engagement: Involvement of organizational
members at various stages can enhance the
capability to deliver higher values so that the
organization can achieve its quality objectives.
 Process Approach: Quality management is an inter-
related process which helps to understand the
results and boot the organization’s performance.

10.  Continual Improvement: Continual improvement is
essential to create new opportunities and enhance
the current level of performance.
 Decision Making: It involves some uncertainty.
Facts, pieces of evidence and data analysis results
help to make effective business decisions.
 Relationship Management: Maintain the success of
the organization by managing the relationships with
its interested parties to enhance the performance .

11. CGMP REGULATIONS
 The cGMP regulations for the manufacture of
pharmaceutical products are contained in Parts 210
and 211 of Title 21 of the Code of Federal
Regulations (CFR)
 Part 210 specifies the scope and applicability of the
cGMP regulations and defines terms used in the
regulations.
 Part 211 contains specific good manufacturing
practice requirements for finished pharmaceuticals
and is divided into Subparts A-K as follows:

12. CONT.......
 A. Scope
 B. Organization and Personnel
 C. Buildings and Facilities
 D. Equipment
 E. Control of Components and Drug Product Containers
and Closures
 F. Production and Process Controls
 G. Packaging and Labeling Control
 H. Holding and Distribution.
 I. Laboratory Controls
 J. Records and Reports
 K. Returned and Salvaged Drug Products

13. QUALITY ASSURANCE FUNCTION
 Quality means the product requirements or attributes
that have a bearing on the product's specified
requirements.
 Quality assurance activities are those processes and
activities conducted to assure that a product or service
consistently satisfies its requirements and is fit for its
intended use. In the pharmaceutical manufacturing
environment, this means the activities conducted to
assure that the pharmaceutical products identity,
strength, purity, potency, and other quality attributes
conform to approved specifications.
 Development of quality systems and risk management
approaches to better assure product quality and fitness
for use.

14. CONT.......
 Pharmaceutical product manufacturers are
increasingly interested in implementing these
approaches because they allow the manufactures to
apply newer quality management principles that they
believe enable them to more effectively are product
quality and better allow harmonization with evolving
international regulatory quality system requirements.

15. REFERENCE
 C.G. Shayne; Pharmaceutical manufacturing
handbook regulations and quality, a john wiley and
sons inc. Publication, page no: 201-237
 Siegel E.B.;Barquest J.M.; et al, Pharmaceutical
manufacturing handbook, John Wiley Publication
Page no. 202-212
 Kaur J. Quality Audit: Introduction, types and
procedure. Pharma Pathway; 2017. Available from:
http://pharmapathway.com/quality-audit-
introductiontypes-and-procedures/.

16. THANK YOU