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350 SOPs on 3 CD's
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" High Quality Cost Effective
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| SOP Control |
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S-001-01-2019 Format and Layout of Standard Operating
Procedures
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S-005-01-2019 Indexing procedure for Stability
Studies.
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S-010-01-2019 Index for Stability SOPs.
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| Starting a Study |
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S-015-01-2019 Initiating a Stability Study.
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S-021-02-2019 Contents of a Stability Protocol.
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S-025-01-2019 Setting the 'Start date' for a Stability
Study.
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S-030-01-2019 Determining the 'Due dates' for
a Stability Study protocol.
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S-035-01-2019 The initial Certificate of Analysis
at To for a Stability Study.
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| Study
Parameters |
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| S-040-01-2019 Setting limits for check
specifications in a Stability Study. |
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S-045-01-2019 Number and size of batches for stability
testing.
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| Sampling |
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S-051-02-2019 Number of samples required for
performing stability tests.
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S-060-01-2019 Labeling of Stability Study Samples.
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S-065-01-2019 Storage configuration of samples
in a stability environment.
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S-070-01-2019 Storing the stability study samples
under controlled conditions prior to analysis.
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| Active Drug
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S-075-01-2019 Stress testing the bulk drug substance
for stability analysis.
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| Study Conditions
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S-080-01-2019 Intervals and climatic conditions
for a US development Stability Study .
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S-085-01-2019 Intervals and climatic conditions
for a US Pivotal/Bioequivalence Stability Study.
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S-090-01-2019 Intervals and climatic conditions
for a US validation/PM Stability Study.
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S-095-01-2019 Placing the Reference Listed Drug
(RLB) on Stability.
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Packaging
Procedures
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S-100-01-2019 Sampling and Testing of Pivotal
Batches - Tablet & Capsule Dosage Forms.
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S-105-01-2019 Sampling and Testing of Pivotal
Batches - Powder & Syrups for Reconstitution.
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Container Systems
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S-110-01-2019 Container-Liner-Closure systems
for a Stability Study.
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S-115-01-2019 Certification of a Container-Liner-Closure
system.
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Test Results
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S-120-01-2019 Reporting test results of a Stability
Study.
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S-125-01-2019 Procedures for handling abnormal
or OOS results in a Stability Study.
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Test Methods
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S-130-01-2019 The control of Analytical methods
#'s and Edition #'s in stability documentation.
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Audit and Review
Raw Data
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S-140-01-2019 Auditing stability data in laboratory
notebooks.
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S-145-01-2019 Cross-referencing laboratory notebooks
with computerized stability documentation.
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Chart Control
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S-150-01-2019 Recording stability study climatic
conditions
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S-155-01-2019 Review and control of temperature
and humidity recording charts.
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Validation and
Sanitation
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S-160-01-2019 Periodic revalidation of climatic
rooms and chambers.
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S-170-01-2019 Sanitation and housekeeping requirements
of climatic chambers.
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Corrective Action
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S-175-01-2019 Fault correcting procedures (after
breakdowns) during a Stability Study.
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S-180-01-2019 Emergency procedures during a Stability
Study.
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In House Methods
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S-185-01-2019 Reserved.
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Stopping a Study
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S-190-01-2019 Conditions for stopping a Stability
Study.
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Self Inspection
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S-210-01-2019 Self inspection procedures in a
stability department.
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Job Description
and Training
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S-215-01-2019 Job description of stability department
personnel
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S-220-01-2019 Using stability SOPs and compliance
program as stability training tools.
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S-225-01-2019 The Do's and Don'ts of a Stability
Study - a department training tool.
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S-230-01-2019 Stability department compliance
staff training
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Reviewing Documentation
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S-245-01-2019 Review and auditing stability study
documentation.
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S-250-01-2019 The layout and format of a regulatory
stability report (a filed report)
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S-255-01-2019 Documentation requirements for a
Stability Study - contents of a stability dossier
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| Closing a Study
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| S-260-01-2019 Accepting and signing-off a completed
stability study. |
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Available
to IAGIM members via IAGIM Center - 24 and
SOPs & Validation Protocols
via IAGIM Online
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