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Table Of Contents

INTRODUCTION
1 SCOPE
2 REFERENCES
3 DEFINITIONS
4 LABORATORY ORGANIZATION AND MANAGEMENT
4.1 ORGANIZATION
4.3 DOCUMENT CONTROL
4.4 CONTRACT REVIEW
4.5 SUBCONTRACTING
4.6 PURCHASES OF SERVICES AND SUPPLIES
4.9 NOTIFICATION OF A POTENTIAL ERROR
4.10 MANAGEMENT SYSTEM IMPROVEMENT
4.11 CORRECTIVE ACTION
4.12 PREVENTIVE ACTION
4.13 CONTROL OF RECORDS
4.14 INTERNAL AUDITS
4.15 MANAGEMENT REVIEWS
4.16 MANAGEMENT OF SECONDARY–TERTIARY RELATIONSHIP
5 TECHNICAL REQUIREMENTS
5.1 GENERAL
5.2 PERSONNEL
5.3 ENVIRONMENTAL CONDITIONS
5.6 MEASUREMENT TRACEABILITY
5.7 SAMPLING
5.8 HANDLING OF TEST AND CALIBRATION ITEMS
5.9 ENSURING THE QUALITY OF TEST AND CALIBRATION RESULTS
5.10 REPORTING
5.11 SECONDARY–TERTIARY PROCEDURES
SPECIFIC CRITERIA FOR GAMMA-RAY CALIBRATIONS
SPECIFIC CRITERIA FOR X-RAY CALIBRATIONS OF SURVEY INSTRUMENTS
SPECIFIC CRITERIA FOR X-RAY CALIBRATIONS OF INSTRUMENTS FOR DIAGNOSTIC LEVELS
SPECIFIC CRITERIA FOR ALPHA-PARTICLE CALIBRATIONS
SPECIFIC CRITERIA FOR SOURCE PRODUCTION AND/OR CALIBRATION
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Published by dr_ifawad
ICH Stability Zones
Zone Type of Climate
Zone I Temperate zone
Zone II Mediterranean/subtropical zone
Zone III Hot dry zone
Zone IV Hot humid/tropical zone
Zone IVb ASEAN testing conditions hot/higher humidity
Long Term Testing Conditions
Climatic Zone Temperature Humidity Minimum Duration
Zone I 21ºC ± 2ºC 45% rH ± 5% rH 12 Months
Zone II 25ºC ± 2ºC 60% rH ± 5% rH 12 Months
Zone III 30ºC ± 2ºC 35% rH ± 5% rH 12 Months
Zone IV 30ºC ± 2ºC 65% rH ± 5% rH 12 Months
Zone IVb 30ºC ± 2ºC 75% rH ± 5% rH 12 Months
Refrigerated 5ºC ± 3ºC No Humidity 12 Months
Frozen -15ºC ± 5ºC No Humidity 12 Months

Accelerated and Intermediate Testing Conditions
Climatic Zone Temperature Humidity Minimum Duration
Accelerated Ambient 40ºC ± 2ºC 75% rH ± 5% rH 6 Months
Accelerated Refrigerated 25ºC ± 2ºC 60% rH ± 5% rH 6 Months
Accelerated Frozen 5ºC ± 3ºC No Humidity 6 Months
Intermediate 30ºC ± 2ºC 65% rH ± 5% rH 6 Months
ICH Stability Zones
Zone Type of Climate
Zone I Temperate zone
Zone II Mediterranean/subtropical zone
Zone III Hot dry zone
Zone IV Hot humid/tropical zone
Zone IVb ASEAN testing conditions hot/higher humidity
Long Term Testing Conditions
Climatic Zone Temperature Humidity Minimum Duration
Zone I 21ºC ± 2ºC 45% rH ± 5% rH 12 Months
Zone II 25ºC ± 2ºC 60% rH ± 5% rH 12 Months
Zone III 30ºC ± 2ºC 35% rH ± 5% rH 12 Months
Zone IV 30ºC ± 2ºC 65% rH ± 5% rH 12 Months
Zone IVb 30ºC ± 2ºC 75% rH ± 5% rH 12 Months
Refrigerated 5ºC ± 3ºC No Humidity 12 Months
Frozen -15ºC ± 5ºC No Humidity 12 Months

Accelerated and Intermediate Testing Conditions
Climatic Zone Temperature Humidity Minimum Duration
Accelerated Ambient 40ºC ± 2ºC 75% rH ± 5% rH 6 Months
Accelerated Refrigerated 25ºC ± 2ºC 60% rH ± 5% rH 6 Months
Accelerated Frozen 5ºC ± 3ºC No Humidity 6 Months
Intermediate 30ºC ± 2ºC 65% rH ± 5% rH 6 Months

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Categories:Types, Research
Published by: dr_ifawad on Jan 30, 2013
Copyright:Attribution Non-commercial

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01/30/2013

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