validation of blister packaging machine

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
1
2
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