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IAGIM - SOPs - Microbiological

 

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

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SOP Control  

S-001-01-2016 Format and Layout of Standard Operating Procedures

 

S-005-01-2016 Indexing procedure for Stability Studies.

 

S-010-01-2016 Index for Stability SOPs.

 

   
Starting a Study  

S-015-01-2016 Initiating a Stability Study.

 

S-021-02-2016 Contents of a Stability Protocol.

 

S-025-01-2016 Setting the 'Start date' for a Stability Study.

 

S-030-01-2016 Determining the 'Due dates' for a Stability Study protocol.

 

S-035-01-2016 The initial Certificate of Analysis at To for a Stability Study.

 

   
Study Parameters  
S-040-01-2016 Setting limits for check specifications in a Stability Study.

 

S-045-01-2016 Number and size of batches for stability testing.

 

   
Sampling  

S-051-02-2016 Number of samples required for performing stability tests.

 

S-060-01-2016 Labeling of Stability Study Samples.

 

S-065-01-2016 Storage configuration of samples in a stability environment.

 

S-070-01-2016 Storing the stability study samples under controlled conditions prior to analysis.

 

   
Active Drug

 

S-075-01-2016 Stress testing the bulk drug substance for stability analysis.

 

   
Study Conditions   

S-080-01-2016 Intervals and climatic conditions for a US development Stability Study .

 

S-085-01-2016 Intervals and climatic conditions for a US Pivotal/Bioequivalence Stability Study.

 

S-090-01-2016 Intervals and climatic conditions for a US validation/PM Stability Study.

 

S-095-01-2016 Placing the Reference Listed Drug (RLB) on Stability.

 

   

Packaging Procedures

 

S-100-01-2016 Sampling and Testing of Pivotal Batches - Tablet & Capsule Dosage Forms.

 

S-105-01-2016 Sampling and Testing of Pivotal Batches - Powder & Syrups for Reconstitution.

 

   

Container Systems

 

S-110-01-2016 Container-Liner-Closure systems for a Stability Study.

 

S-115-01-2016 Certification of a Container-Liner-Closure system.

 

   

Test Results

 

S-120-01-2016 Reporting test results of a Stability Study.

 

S-125-01-2016 Procedures for handling abnormal or OOS results in a Stability Study.

 

   

Test Methods

 

S-130-01-2016 The control of Analytical methods #'s and Edition #'s in stability documentation.

 

   

Audit and Review Raw Data

 

S-140-01-2016 Auditing stability data in laboratory notebooks.

 

S-145-01-2016 Cross-referencing laboratory notebooks with computerized stability documentation.

 

   

Chart Control

 

S-150-01-2016 Recording stability study climatic conditions

 

S-155-01-2016 Review and control of temperature and humidity recording charts.

 

   

Validation and Sanitation

 

S-160-01-2016 Periodic revalidation of climatic rooms and chambers.

 

S-170-01-2016 Sanitation and housekeeping requirements of climatic chambers.

 

   

Corrective Action

 

S-175-01-2016 Fault correcting procedures (after breakdowns) during a Stability Study.

 

S-180-01-2016 Emergency procedures during a Stability Study.

 

   

In House Methods

 

S-185-01-2016 Reserved.

 

   

Stopping a Study

 

S-190-01-2016 Conditions for stopping a Stability Study.

 

   

Self Inspection

 

S-210-01-2016 Self inspection procedures in a stability department.

 

 

 

Job Description and Training

 

S-215-01-2016 Job description of stability department personnel

 

S-220-01-2016 Using stability SOPs and compliance program as stability training tools.

 

S-225-01-2016 The Do's and Don'ts of a Stability Study - a department training tool.

 

S-230-01-2016 Stability department compliance staff training

 

   

Reviewing Documentation

 

S-245-01-2016 Review and auditing stability study documentation.

 

S-250-01-2016 The layout and format of a regulatory stability report (a filed report)

 

S-255-01-2016 Documentation requirements for a Stability Study - contents of a stability dossier

 

   
Closing a Study  
S-260-01-2016 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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