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Archive of SOPs - STABILITY

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e-SOPs updated annually during December.
SOP Control  

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.


Starting a Study  

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.


Study Parameters  
S-040-02-2016 Setting limits for check specifications in 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.


Active Drug


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


Study Conditions   

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.


45 SOPs


Pharmaceutical | Analytical | Microbiological | Stability | Stability Summaries

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