IAGIM - Drug Development Association

IAGIM - SOPs - Microbiological


Archive of SOPs-Stability Studies
Pharmaceutical - | --Analytical - | --Microbiological - | -Stability

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SOP Control  

S-001-01-2019 Format and Layout of Standard Operating Procedures


S-005-01-2019 Indexing procedure for Stability Studies.


S-010-01-2019 Index for Stability SOPs.


Starting a Study  

S-015-01-2019 Initiating a Stability Study.


S-021-02-2019 Contents of a Stability Protocol.


S-025-01-2019 Setting the 'Start date' for a Stability Study.


S-030-01-2019 Determining the 'Due dates' for a Stability Study protocol.


S-035-01-2019 The initial Certificate of Analysis at To for a Stability Study.


Study Parameters  
S-040-01-2019 Setting limits for check specifications in a Stability Study.


S-045-01-2019 Number and size of batches for stability testing.



S-051-02-2019 Number of samples required for performing stability tests.


S-060-01-2019 Labeling of Stability Study Samples.


S-065-01-2019 Storage configuration of samples in a stability environment.


S-070-01-2019 Storing the stability study samples under controlled conditions prior to analysis.


Active Drug


S-075-01-2019 Stress testing the bulk drug substance for stability analysis.


Study Conditions   

S-080-01-2019 Intervals and climatic conditions for a US development Stability Study .


S-085-01-2019 Intervals and climatic conditions for a US Pivotal/Bioequivalence Stability Study.


S-090-01-2019 Intervals and climatic conditions for a US validation/PM Stability Study.


S-095-01-2019 Placing the Reference Listed Drug (RLB) on Stability.



Packaging Procedures


S-100-01-2019 Sampling and Testing of Pivotal Batches - Tablet & Capsule Dosage Forms.


S-105-01-2019 Sampling and Testing of Pivotal Batches - Powder & Syrups for Reconstitution.



Container Systems


S-110-01-2019 Container-Liner-Closure systems for a Stability Study.


S-115-01-2019 Certification of a Container-Liner-Closure system.



Test Results


S-120-01-2019 Reporting test results of a Stability Study.


S-125-01-2019 Procedures for handling abnormal or OOS results in a Stability Study.



Test Methods


S-130-01-2019 The control of Analytical methods #'s and Edition #'s in stability documentation.



Audit and Review Raw Data


S-140-01-2019 Auditing stability data in laboratory notebooks.


S-145-01-2019 Cross-referencing laboratory notebooks with computerized stability documentation.



Chart Control


S-150-01-2019 Recording stability study climatic conditions


S-155-01-2019 Review and control of temperature and humidity recording charts.



Validation and Sanitation


S-160-01-2019 Periodic revalidation of climatic rooms and chambers.


S-170-01-2019 Sanitation and housekeeping requirements of climatic chambers.



Corrective Action


S-175-01-2019 Fault correcting procedures (after breakdowns) during a Stability Study.


S-180-01-2019 Emergency procedures during a Stability Study.



In House Methods


S-185-01-2019 Reserved.



Stopping a Study


S-190-01-2019 Conditions for stopping a Stability Study.



Self Inspection


S-210-01-2019 Self inspection procedures in a stability department.




Job Description and Training


S-215-01-2019 Job description of stability department personnel


S-220-01-2019 Using stability SOPs and compliance program as stability training tools.


S-225-01-2019 The Do's and Don'ts of a Stability Study - a department training tool.


S-230-01-2019 Stability department compliance staff training



Reviewing Documentation


S-245-01-2019 Review and auditing stability study documentation.


S-250-01-2019 The layout and format of a regulatory stability report (a filed report)


S-255-01-2019 Documentation requirements for a Stability Study - contents of a stability dossier


Closing a Study  
S-260-01-2019 Accepting and signing-off a completed stability study.  

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




Download an Example SOP and another One - Just to See

Pharmaceutical | Analytical | Microbiological | Stability


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