S-001-02-2016 Format and Layout of Standard Operating Procedures

S-005-02-2016 Indexing procedure for Stability Studies.

S-010-02-2016 Index for Stability SOPs.

S-015-02-2016 Initiating a Stability Study.

S-020-02-2016 Contents of a Stability Protocol.

S-025-02-2016 Setting the 'Start date' for a Stability Study.

S-030-02-2016 Determining the 'Due dates' for a Stability Study protocol.

S-035-02-2016 The initial Certificate of Analysis at To for a Stability Study.

S-045-02-2016 Number and size of batches for stability testing.

S-050-02-2016 Number of samples required for performing stability tests.

S-060-02-2016 Labeling of Stability Study Samples.

S-065-02-2016 Storage configuration of samples in a stability environment.

S-070-02-2016 Storing the stability study samples under controlled conditions prior to analysis.

S-075-02-2016 Stress testing the bulk drug substance for stability analysis.

S-080-02-2016 Intervals and climatic conditions for a US development Stability Study .

S-085-02-2016 Intervals and climatic conditions for a US Pivotal/Bioequivalence Stability Study.

S-090-02-2016 Intervals and climatic conditions for a US validation/PM Stability Study.

S-095-02-2016 Placing the Reference Listed Drug (RLB) on Stability.

Packaging Procedures

S-100-02-2016 Sampling and Testing of Pivotal Batches - Tablet & Capsule Dosage Forms.

S-105-02-2016 Sampling and Testing of Pivotal Batches - Powder & Syrups for Reconstitution.

Container Systems

S-110-02-2016 Container-Liner-Closure systems for a Stability Study.

S-115-02-2016 Certification of a Container-Liner-Closure system.

Test Results

S-120-02-2016 Reporting test results of a Stability Study.

S-125-02-2016 Procedures for handling abnormal or OOS results in a Stability Study.

Test Methods

S-130-02-2016 The control of Analytical methods #'s and Edition #'s in stability documentation.

Audit and Review Raw Data

S-140-02-2016 Auditing stability data in laboratory notebooks.

S-145-02-2016 Cross-referencing laboratory notebooks with computerized stability documentation.

Chart Control

S-150-02-2016 Recording stability study climatic conditions

S-155-02-2016 Review and control of temperature and humidity recording charts.

Validation and Sanitation

S-160-02-2016 Periodic revalidation of climatic rooms and chambers.

S-170-02-2016 Sanitation and housekeeping requirements of climatic chambers.

Corrective Action

S-175-02-2016 Fault correcting procedures (after breakdowns) during a Stability Study.

S-180-02-2016 Emergency procedures during a Stability Study.

In House Methods

S-185-02-2016 Reserved.

Stopping a Study

S-190-02-2016 Conditions for stopping a Stability Study.

Self Inspection

S-210-02-2016 Self inspection procedures in a stability department.

Job Description and Training

S-215-02-2016 Job description of stability department personnel

S-220-02-2016 Using stability SOPs and compliance program as stability training tools.

S-225-02-2016 The Do's and Don'ts of a Stability Study - a department training tool.

S-230-02-2016 Stability department compliance staff training

Reviewing Documentation

S-245-02-2016 Review and auditing stability study documentation.

S-250-02-2016 The layout and format of a regulatory stability report (a filed report)

S-255-02-2016 Documentation requirements for a Stability Study - contents of a stability dossier

Closing a Study

S-260-02-2016 Accepting and signing-off a completed stability study.