The document, presented by Vijay Kumar, discusses the Quality Management System (QMS) in the pharmaceutical industry, emphasizing its role in improving product quality and minimizing recall risks. It outlines essential elements such as quality policies, risk management, objectives, and the importance of quality manuals, procedures, and work instructions tailored to organizational needs. The document emphasizes that a structured approach is crucial for effective implementation of a QMS, incorporating elements like responsibilities, document control, and continual improvement.

1. Presented by :-
Vijay Kumar
B.Pharmacy (7thsem)
75161827
Presented to :-
Mr. Kashish Wilson
( Assistant Professor MMSOP )

2. (QMS) – Quality management system
– QMS helps in pharmaceutical to improve the product
quality and minimize the risk of product recall
– Quality management system a set of interacting
elements based on procedures , policies ,resources
and objectives that are established collectively to
guide an organization.
Introduction

3. Factors essential in developing a process based
quality management system in organization
(i) Quality Policy
(ii) Quality risk management
(iii)Quality objectives

4. ELEMENTS AND REQUIREMENTS OF A QUALITY
MANAGEMENT SYSTEM
– Quality manual
– Procedures, instructions, and records
– Data management
– Internal processes
– Customer satisfaction from product quality
– Improvement opportunities
– Quality analysis
– The organization’s quality policy and quality objectives
General elements of QMS includes:

5. The basic steps to implementing a quality management system are as
follows:-
– Design
– Build
– Deploy
– Control
– Measure
– Review
– Improve

6. List of various data of Quality Management
System in filling department of various
Pharma Companies?
– 1) Quality manual.
– 2) Quality policy
– 3) Quality procedures
– 4) Work instructions.

7. 1) Quality manual.
The manual should fit your organization. The structure and the
content of the manual can vary depending on the size of the
organization, the complexity of operations, and the competence of
the personnel. Small organizations can document the entire QMS in
one manual. On the other side, large international organizations
may have several different quality manuals. Generally, the manual
includes the QMS scope, exclusions from the standard, references
to relevant documents, and the business process model.

8. 2) Quality policy
– A policy represents a declarative statement by an organization. A
Quality policy should state the commitment of the organization to
quality and continual improvement. Usually, this policy is used for
promotional purposes and should be displayed in the organization’s
premises and posted on websites, so a clear and short quality policy
is convenient and is the general practice.
– The Quality policy defines the quality objectives to which the
organization strives. The quality goals of organizations are defined
by quantifying the quality objectives.

9. 3) Quality procedures
– Quality procedures can have different formats and structures.
They can be described through text
– they can be more structured by using tables
– they can be more illustrative through flow charts
– they can be any combination of the above.

10. Quality procedures should include the following
elements:
– Title , Purpose, Scope
– Responsibilities and authorities of all people/functions included in any part the procedure
– Records that result from the activities described in the procedure should be defined and listed;
– Document control – identification of changes, date of review, approval and version of the
document should be included in accordance with the established practice for document control.
– Description of activities – this is the main section of the procedure; it relates all the other elements
of the procedure and describes what should be done, by whom and how, when and where.

11. 4) Work instructions
– Work instructions can be part of a procedure, or they can be
referenced in a procedure. Generally, work instructions have a
similar structure to the procedures and cover the same elements;
however, the work instructions include details of activities that
need to be realized, focusing on the sequencing of the steps, tools,
and methods to be used and required accuracy.

12. Regards:- vijay Kumar