Six system inspection model pharmaceutical D-Astar.pptx

SIX SYSTEM
INSPECTION
MODEL
Presenter Name:-
Deva Pundkar

AGENDA
• INTRODUCTION
• OUALITY
MANAGEMENT
SYSTEM
• FACILITY AND
EQUIPEMENT
• LABORATORY
CONTROL SYSTEM
• MATERIAL SYSTEM
• PACKAGING AND
LABELLING SYSTEM
• CONCEPT OF SELF
INSPECTION
• Change management
and change control
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INTRODUCTION
Six system inspection model which can help
pharmaceutical manufacturers to follow CGMP
guidelines. The six systems inspection model are
as quality, production, facilities equipment,
laboratory controls, materials, and packaging and
labeling.

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6 sigma is divvied into 2 parts
1. DMAIC
2. DMADV

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Quality management system:-
A quality management system (QMS) is a system in which documents processes, procedures,
as well as responsibilities for attaining quality approach and goals. To enhance effectiveness as
well as efficiency a QMS helps to communicate to an organization's activities to meet customer
and regulatory requirements.
key Component of a Quality Management System:- Quality is defined as properties as well
as features of a product to which have ability to fulfill requirement of customers. This can be
differ between industries as well as organization. Quality is the thing which is eventually
correlate expectation of customer and their satisfaction .QMS have plan to give up a structure
for organizations to design and maintain customer connections by knowing the customer's
choice and their requirement. Throughout the product lifecycle customer satisfaction is get with
QMS along with the association of people. process, and technology. One of the worlds most
broadly adopted QMS, ISO 9001:2015, which involve a sequence of quality principles as:-
1. Focus on customer
2. Administration
3. To engage the people
4. Approach towards process
5. simultaneous enhancement
6. decision is based on authentication
7. To manage the relationship

OBJECTIVES OF QUALITY
To create objectives of quality is a general need of QMS standards,
involving ISO 9001. Such objectives are plan to inspire organizations
to give up important goals as well as purpose for the QMS. Express
the objectives of organization's aim into application by preparing a link
between customer requirements as well as particular, measurable,
and achievable plans. To write objectives in well manner is main aim
for initiative of QMS also this develop Well- written objectives lend
purpose to a QMS initiative and it will help to establish a customer-
centric culture in an organization.

PRODUCTION SYSTEM
Production system include planning for production i.e. production
process considering difficulties and deciding that how the product
Production control is continuously maintained the production to
prepare the product of given specifications. Controlling of production
is a deal with quality of product as well as progress in production,
standards and correction of the problems .
Production system may be defined as a structure of activities where
inputs are modify into value added to products.

PRODUCTION PLANNING
OBJECTIVES
1. To produce the product within time planning is necessary to produce
cost effective product
2. Marketing of products by passing away difficulties in production.
3. Demands of peoples and marketing variations there is planning
necessary for meeting to discuss the issues
4. Planning increases the systematic way in case of series of
operations are included in the production of a product.
5. To enhance productivity too.

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Types Of Production Systems.
1. Continuous production system
Continuous production system includes constant flow of materials into
methods and equipment to give up standard products in large quantity.
Operate the material and instrument by automatic systems E.g. Large
volume parenteral
2. Intermittent production system
Intermittent production system includes constant flow of material into
methods and equipment to give up finished small quantity product .
Operate the material and instrument by skilled person . E.g. Capsule,
tablets, liquid orals
3.Dispatching records
Dispatching record is the linkage between production and sales

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To mention the particular facility and requirement of equipment there is need of the technical
experts who know about pharmaceutical science, risk factor, as well as manufacturing
processes related to product . All initial design criteria and procedures related to facilities and
equipment or any subsequent changes are comes under the CGMP regulations, in that the
quality unit (QU) has the responsible to review and approve this. In the CGMP guidelines
equipment should be qualified, calibrated, cleaned as well as to prevent the contamination.
Basic thing is that the CGMP guidelines require a high standard for calibration and
maintenance than that of the most non pharmaceutical quality system models. Most of quality
systems focus on testing of equipments but in the CGMP guidelines having significance for
process equipment as on testing equipment. The CGMP system includes activities which give
us and this system includes the measures and activities which provide a suitable physical
environment as well as resources that are used in the production of the drugs or drug
products.
This involve:
a) maintenance of Buildings and facilities
b) Qualifications of Equipment i.e. installation and operation; calibration of equipment and
preventative maintenance; and cleaning and appropriate process for validation. As the
view of evaluation process performance qualification will be analyze the overall process
validation is done in the system where the process is operated; and,c) Facilities that are
not applicable for the products such as HVAC, compressed gases, steam and water
system. In the cGMP regulation, 21 CFR 211 Subparts B -including Organization and
Personnel,

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LABORATORY
CONTROL SYSTEM

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Laboratory Control System consisting with the activities regarding to
laboratory procedures, evaluation, analytical methods development and
validation as well as stability program. The cGMP regulation, 21 CFR 211
includes-Subparts B having Organization and Personnel related to
Responsibilities of quality control unit, Personnel qualifications, Personnel
responsibilities. Consultants. Subparts I having Laboratory Controls
related to General requirements, Testing and release for distribution.
Stability testing. Special testing requirements. Reserve samples, Subparts
J having Records and Reports related to General requirements,
Equipment. cleaning and use log, Component, drug product container,
closure, and labeling records. Master production and control records.
Batch production and control records. Production record review.
Laboratory records. Distribution records. Complaint files. Subparts K
having returned and Salvaged Drug Products related to Returned drug

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MATERIAL SYSTEM

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Material system includes the major activity
to control the finished product, components
involving water or any gas that incorporated
to the product, container as well as closures.
Validation of control processes, drug
storage, distribution controls as well as
records are comes under this material
system.

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PACKAGING AND
LABELING SYSTEM

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Packing and labeling consist activities which controls the packaging
and labeling of drug or drug product .This system include well
documentation of procedures, label examination and usage, label
storage and issuance, packaging and labeling operations controls,
and validation of these operations.
The cGMP regulation, 21 CFR 211 Subparts B, G, and J.
Subparts B related to Responsibilities of quality control unit,
Personnel qualifications, and Personnel responsibilities. Consultants.
Subparts G related to Materials examination and usage criteria,
labeling issuance, Packaging and labeling operations. Tamper-evident
packaging requirements for over-the-counter (OTC) human drug
products Drug product inspection. Expiration dating Subparts J
related to General requirements, Equipment cleaning and use log,
Component, drug product container, closure, and labeling records.
Master production and contro records. Batch production and control
records. Production record review. Laboratory records. Distribution
records. Complaint files.

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CONCEPT OF SELF
INSPECTION

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Self-inspection is generally a process to
analyze self-performance related to any
aspect of quality Self inspection help to
identify the problems whether problem or
defect is major, minor or critical in nature.
A self-inspection concept help to any
organization that should include every
person from high level to the front line
worker.

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CHANGE
MANAGEMENT AND
CHANGE CONTROL

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To assure changes to a product or system which are introduced in
controlled and coordinated manner there must be recognized process
used in change control in quality management systems (QMS) as well
as in information technology (IT) systems. Changes which are not
necessary that will minimizes to introduced in a system without any
forward planning also introduced failure into system or changes by other
users of software which are not performed. The aim of a change control
procedure mainly involve minimum disturbance to system also
decreasing previous steps, and cost-effective use of source in applying
changes. Now a days this change control is used in different products
and in organization. For IT systems it is a important fact of the wide
range authority of change management. General examples from the
computer as well as connections of environments are blotches to
software products, installation of latest effective systems, improve to
network routing tables, or changes to the electrical power systems
supporting just like infrastructure.

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OUT OF SPECIFICATION

THANK YOU
Sample Footer Text
Presenter Name: Deva Pundkar ( D-A Star )
Email Address: deva.pundkar20@gmail.com
2/7/20XX 30

Six system inspection model pharmaceutical D-Astar.pptx

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