S-001-01-2008 Format and Layout of Standard Operating Procedures

S-005-01-2008 Indexing procedure for Stability Studies.

S-010-01-2008 Index for Stability SOPs.

S-015-01-2008 Initiating a Stability Study.

S-020-01-2008 Contents of a Stability Protocol.

S-025-01-2008 Setting the 'Start date' for a Stability Study.

S-030-01-2008 Determining the 'Due dates' for a Stability Study protocol.

S-035-01-2008 The initial Certificate of Analysis at To for a Stability Study.

S-045-01-2008 Number and size of batches for stability testing.

S-050-01-2008 Number of samples required for performing stability tests.

S-060-01-2008 Labeling of Stability Study Samples.

S-065-01-2008 Storage configuration of samples in a stability environment.

S-070-01-2008 Storing the stability study samples under controlled conditions prior to analysis.

S-075-01-2008 Stress testing the bulk drug substance for stability analysis.

S-080-01-2008 Intervals and climatic conditions for a US development Stability Study .

S-085-01-2008 Intervals and climatic conditions for a US Pivotal/Bioequivalence Stability Study.

S-090-01-2008 Intervals and climatic conditions for a US validation/PM Stability Study.

S-095-01-2008 Placing the Reference Listed Drug (RLB) on Stability.

Packaging Procedures

S-100-01-2008 Sampling and Testing of Pivotal Batches - Tablet & Capsule Dosage Forms.

S-105-01-2008 Sampling and Testing of Pivotal Batches - Powder & Syrups for Reconstitution.

Container Systems

S-110-01-2008 Container-Liner-Closure systems for a Stability Study.

S-115-01-2008 Certification of a Container-Liner-Closure system.

Test Results

S-120-01-2008 Reporting test results of a Stability Study.

S-125-01-2008 Procedures for handling abnormal or OOS results in a Stability Study.

Test Methods

S-130-01-2008 The control of Analytical methods #'s and Edition #'s in stability documentation.

Audit and Review Raw Data

S-140-01-2008 Auditing stability data in laboratory notebooks.

S-145-01-2008 Cross-referencing laboratory notebooks with computerized stability documentation.

Chart Control

S-150-01-2008 Recording stability study climatic conditions

S-155-01-2008 Review and control of temperature and humidity recording charts.

Validation and Sanitation

S-160-01-2008 Periodic revalidation of climatic rooms and chambers.

S-170-01-2008 Sanitation and housekeeping requirements of climatic chambers.

Corrective Action

S-175-01-2008 Fault correcting procedures (after breakdowns) during a Stability Study.

S-180-01-2008 Emergency procedures during a Stability Study.

In House Methods

S-185-01-2008 Reserved.

Stopping a Study

S-190-01-2008 Conditions for stopping a Stability Study.

Self Inspection

S-210-01-2008 Self inspection procedures in a stability department.

Job Description and Training

S-215-01-2008 Job description of stability department personnel

S-220-01-2008 Using stability SOPs and compliance program as stability training tools.

S-225-01-2008 The Do's and Don'ts of a Stability Study - a department training tool.

S-230-01-2008 Stability department compliance staff training

Reviewing Documentation

S-245-01-2008 Review and auditing stability study documentation.

S-250-01-2008 The layout and format of a regulatory stability report (a filed report)

S-255-01-2008 Documentation requirements for a Stability Study - contents of a stability dossier

Available to IAGIM members via IAGIM Center - 24 and SOPs & Validation Protocols via IAGIM Online