The document discusses validation of packaging machines. It outlines the objectives, importance, and responsibilities of process validation. Validation establishes that a machine meets installation, operational, and performance qualification requirements. The document describes user requirement specifications that cover mandatory parts to guarantee final product quality and compliance. It details the scope, steps in the machine's lifecycle, types of packaging machines, their detailed assembly, key parameters, and the validation SOP.

1. Presents by
Mr. Nilesh Utpure
Under the guidance of
Miss. Gurjar P. N.
Sharadchandra Pawar College of Pharmacy (otur) Pune-412409

2. Validation
 Key process for effective quality assurance
 Establishes the documented evidence provide high
degree of assurance
 To check process/ equipment that used to produce
product/ result
 Used to produce the product at its predetermined
specification & quality attribute
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3. Objectives of Process Validation
 Software verification & validation
 Describes the program inspection process & its role in
verification & validation
 Describes clean room software development
 Explain static analysis as a verification technique
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4. Importance of Process Validation
 Government regulation
 Rapid automation
 Improved employee awareness
 Increased output
 Reduction in quality cost
 Process optimization
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5. Purpose & Responsibilities
 To describe the procedure for validation of machine
which ensures that it meet installation, operational &
performance qualification requirements
 It is the responsibility of the production manager &
technical service manager
 The QA manager is responsible for SOP compliance
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6. User Requirement Specification
(USR)
 Should be treated as contractual document
 It should be minimum & cover all mandatory parts
including those necessary to guarantee the final
product quality & achieve compliance with rules
 Ideally, requirements should be independent from the
suppliers product & express the customer needs
without addressing specific design solutions
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7. URS Scope
 It should be not limited to
1. Level 1 –full details of end user operability
2. Level 2 –full details of functionality
3. Level 3 –software functionality interface
4. Full description of the required system performance
5. Documentation requirements
6. Training requirements
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8. Steps involved in life cycle
 Design qualification (DQ)
 Installation qualification (IQ)
 Operational qualification (OQ)
 Performance qualification (PQ)
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9. Types of packaging machine
 Strip packaging
 Blister packaging
 Aluminum packaging
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10. Detailed assembly
 Unwinding station
 Heating station
 Forming station
 Cooling station
 Feeding station
 Sealing station
 Cooling station
 Labeling station
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11. Parameters
 Speed
 Heating
 Punching
 Cooling
 Printing
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12. Validation SOP
SOP No. Val: Effective Date:
Approved By:
TITLE: Blistering Machine
Author: _____________________
Name/ Title/ Department Signature
Checked By: _____________________
Name, Title/ Department Signature
Approved By: _____________________
Name/ Title/ Department Signature
Revisions:
No. Section Pages Date
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2
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