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QUALITY MANAGEMENT SYSTEM (QMS) E00 GOOD ENGINEERING

Q00-00-00 Policy Statement – QMS Reference: PRACTICE (GEP)
Q00-00-01 QMS Flowchart FDA Quality System Approach to cGMP Sept.2006;
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FDA 21 CFR 210/211; ISO 9001-2000; ICH-Q10

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For details of GEP - see separate sheet

· Q04-0102
· Q04-0103
Document Control
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· Q04-0104
Good Documentation Practices
Change Control Q04 CORE CONCEPTS
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· Q04-0105 Document Change Control
M P PROJECT

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Q05 Management Responsibilities RESOURCE
Q06 IG COMMON
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Q07 Manufacturing Operations Q08 Evaluation Activities
& Requirements REQUIREMENTS & MANAGEMENT PRACTICES &
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ISO Section 7; FDA Section IV/C ISO section 8; FDA IV/D

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ISO Section 5; FDA Section IV/A ISO Section 6; FDA Section IV/B
Policy Statement
Policy Statement Policy Statement Policy Statement

Q07-10
Q08-01 · Site Quality Council
Q06-01 Plan Product · Product Design Plan
Monitoring & · Customer Complaints E04
Personnel/Human Resources Realization · Quality Plan
measurement · Internal Audit
Requirements ISO 7.1, FDA C/1 OPERATIONS &
ISO Section 6.2, FDA IV/B/2
ISO 8.2, FDA D/2 · Annual Product Review
MAINTENANCE
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· Quality Policy, Quality Manual, · Training Policy s.co .co
Identify & Review Customer’s
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Q07-20 Requirements;
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ISO 7.2, FDA C/1

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Design, Develop &
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ISO Section 6.3, FDA IV/B/3
& Processes · Design Verification/Validation;
GH H T ISO 7.3, FDA C/1
· Design Change Control
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ISO 8.4, FDA D1
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· Component Criticality Analysis Purchasing &
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· Equipment & Drawing Control · Verify purchased products a
ISO 7.4, FDA C/2
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· Equipment Pre-Qualification Process &
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Documentation
Make Quality flow at
Improvements is rm
· Q06-32 Equipment Qualification Q07-50
Perform & Monitor
· Validation (CV, PV, CSV) ISO 8.5, FDA D6 Th io fo
· Q06-36 Maintenance Program
· Q06-37 Laboratory Facility Mfg Operations
· Production & Process Control
· QC Criteria (In-process testing,
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ISO 7.5, FDA C/3
Stability Program)
· QA & QC Checkpoints – batch
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release, sampling
Q06-40 · QC Lab Operations
Control Outsourced Operation,
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Work Environment
ISO 6.4, FDA IV/B/4
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· Suppliers – Technical Agreement
.GM Q07-60
Control of · Calibration Program &
· Suppliers – External Audit, w
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monitoring & Schedules of Devices;
Monitoring measuring devices · Equipment Control www.GMPtemplates.com
· Q06-46 Environmental MonitoringT
© ISO 7.6, FDA C/3
Online Store for GMP Document Templates
· Q06-47 EH&S H
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O PY Q07-70
Address
· Document Deviations;
Address & control
Quality Management System
C Nonconformities
ISO 7.7, FDA C/4
CAPA
SIZE Filename DWG NO REV
[email protected]
A3 Q00-00-01 QMS Flowchart 2
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