DRUG DEVELOPMENT SOPs
" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "... .

Archive of SOPs - ANALYTICAL

330 + Key Selected e-SOPs on CD - View


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Download an Example SOP and Another
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e-SOPs updated annually during October to December
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Index No SOPs  
A-001-01-2016 Indexing procedure for analytical SOPs.  
A-010-01-2016 Index of analytical SOPs.  
A-012-01-2016 Authorization signatures for analytical SOPs.  
A-015-01-2016 Numbering and format of analytical SOPs.  
A-020-01-2016 Circulation of analytical SOPs.  
A-025-01-2016 Annual Review of analytical SOPs.  
A-030-01-2016 Reserved.  
   

Development Notebooks

 
A-035-01-2016 Issue and use of analytical development notebooks  
A-040-01-2016 Signing procedures for analytical notebooks  
A-045-01-2016 Entering raw data in laboratory notebooks  
A-050-01-2016 Using USP terminology in analytical methods  
A-055-01-2016 Verifying analytical calculations performed by (in-house) computer programs  
A-060-01-2016 Release of Results from the Analytical R&D Laboratories.  
A-062-02-2016 Reviewer Checklist .  
   
Auditing  
A-065-01-2016 Review and auditing of analytical laboratory notebooks  
A-070-01-2016 Correction procedures in laboratory notebooks  
A-075-01-2016 Archiving of laboratory notebooks  
A-080-01-2016 Laboratory Note Book Checklist.  
   
Development Quality Assurance  
A-085-01-2016 Procedures for Analytical Change Control  
A-090-01-2016 Reserved.  
   
Incoming Samples  
A-095-01-2016 General Analytical Sample Preparation.  
A-100-01-2016 Receipt and logging-in of analytical laboratory samples  
A-105-01-2016 Storage of samples prior to testing  
A-110-01-2016 Storage time limits of samples prior to testing.  
A-115-01-2016 Disposition of tested laboratory samples (including time limits).  
A-120-01-2016 Reserved.  
   
Reagent and Solutions  
A-125-01-2016 Handling and preparation of analytical standards  
A-130-01-2016 Handling and preparation of volumetric solutions  
A-135-01-2016 Labeling requirements of reagents and solutions  
A-140-01-2016 Preparation and storage of analytical glassware  
A-145-01-2016 Reserved.  
   
Test Methods  
A-150-01-2016 Availability and control of approved test methods.  
A-155-01-2016 Updating Pharmacopeial methods with supplemental monographs.  
A-160-01-2016 Abbreviated Raw Materials testing Procedures.  
A-165-01-2016 Approval signatures for Raw materials and Approved suppliers.  
A-170-01-2016 Retesting Procedures.  
   
Calculations  
A-175-01-2016 Recording and checking of method calculations  
A-180-01-2016 Procedures for rounding off analytical numbers  
   
Active Materials  
A-190-01-2016 Active Drug Substances for Generic Drugs  
A-195-01-2016 Developing Product Formula with approved Actives  
A-200-01-2016 Development Inventory Records for the Active Drug Substance  
A-205-01-2016 Reserved.  
   
Drug Substance  
A-210-01-2016 Drug substance impurity assays  
A-215-01-2016 Drug substance impurities profiles  
A-220-01-2016 Drug substance specifications  
A-225-01-2016 Drug substance approval procedures  
A-235-01-2016 Drug substance approved suppliers  
   
The Reference Listed Drug  
A-240-01-2016 Reserved  
A-245-01-2016 Testing the Reference Listed Drug (RLD)  
   
Drug Product  
A-250-01-2016 Drug substance impurity assays  
A-255-01-2016 Drug substance impurities profiles  
A-260-01-2016 Drug substance Specifications  
A-265-01-2016 Limit test on impurities  
A-270-01-2016 Validation of limit tests for impurities  
A-272-01-2016 Validation of Assay and/or Impurities Determination  
A-275-01-2016 Assay determination by HPLC and GC methods.  
A-276-02-2016 Assay determination by HPLC and GC methods -Details.  
   
Container-liner-closure Systems  
A-280-01-2016 Testing Container-Liner-Closure systems for Generic Development  
   
Sample Preparation  
A-290-01-2016 General analytical sample preparation  
A-295-01-2016 Number of samples and injections for assays  
A-300-01-2016 Standards and system suitability for HPLC testing  
A-304-01-2016 Working and Impurity Standards - Use and Qualification  
A-305-01-2016 Working with Reference Standards and In-house Standards.  
   
Validation  
A-310-01-2016 Using ID numbers for identifying laboratory instrumentation.  
A-315-01-2016 Validation of stability-indicating (S-I) methods  
A-320-01-2016 Validation of in-house analytical methods  
A-325-01-2016 Using stability indicating (S-I) methods  
A-335-01-2016 Analytical methods not requiring (full) validation  
A-340-01-2016 Contents of an analytical validation protocol  
A-345-01-2016 Standardizing and transferring S-I methods and assay validations.  
A-350-01-2016 Change Control Procedures.  
   
Contract Laboratories  
A-355-01-2016 Auditing procedures for a contract analytical laboratory.  
A-365-01-2016 Mail/fax auditing procedures for a contract laboratory.  
   
Process Qualification Batch (Scaled-up)  
A-375-01-2016 Process Qualification Batch analytical requirements  
A-380-01-2016 Side-by-side analytical comparison for process qualification & pivotal batch  
A-385-01-2016 Reserved.  
   
Pivotal Batch  
A-390-01-2016 Pivotal Batch analytical requirements  
A-395-01-2016 Doís and Doníts when preparing for pivotal testing  
A-400-01-2016 Checklist for pivotal batch analytical documentation  
A-405-01-2016 Side-by-side analytical comparison for pivotal and validation batch  
   
Investigations  
A-415-01-2016 Procedures for handling OOS results  
A-420-01-2016 Procedures for repeat testing (using two stages)  
A-425-01-2016 Procedures for invalidating test results and graphs  
A-430-01-2016 Investigation reports after repeat testing  
A-435-01-2016 Evaluation of Significant Change in Stability Test Results.  
   
Analytical Development Reports  
A-440-01-2016 Checklist for an analytical development report  
A-445-01-2016 Analytical Development Reports  
A-448-01-2016 Preparing a standard Certificate of Analysis  
   
Analytical Transfer Documentation (TTDs)  
A-450-01-2016 Check list of an analytical TTD file  
A-455-01-2016 Analytical transfer from development to QC of mnf. facility.  
A-460-01-2016 Change Control Form.  
   
Chart Control  
A-465-01-2016 Routine signing and checking of temperature recording charts  
A-470-01-2016 Review & control of temperature & humidity recording charts.  
A-475-01-2016 Handling of Instrument Graphs, Charts and Print-outs  
   
Sanitation  
A-480-01-2016 Good House Keeping Practice in an analytical laboratory.  
A-485-01-2016 Cleaning and sanitation procedures for laboratory equipment.  
A-490-01-2016 Garmenting procedures for laboratory personnel  
   
Calibration, Validation and Qualification  
A-495-01-2016 Itemized list of laboratory equipment  
A-500-01-2016 IQOQ requirements for laboratory equipment  
A-505-01-2016 Calibration requirements for laboratory equipment  
A-510-01-2016 Corrective action procedures for out-of-calibration instrumentation.  
A-515-01-2016 Operational Instructions for laboratory equipment  
A-516-01-2016 Calibration of pH meters  
A-517-01-2016 Instrument performance checks protocol calibration of pH meter electrode system  
A-518-02-2016 Calibration of pH meters - Detailed  
A-519-01-2016 Performance Checks GC Integrator HP 3396 Series II, HP 3393-A Varian 4270  
A-520-01-2016 Annual qualification program for laboratory equipment  
A-524-01-2016 Performance verification of Bausch & Lomb and Milton Roy spectrophotometers  
A-525-01-2016 Spectronic Standards - Test Calibration Form # [001]  
A-526-01-2016 Wavelength Accuracy Form - # [005]  
A-527-01-2016 Control of Absorbances Form - #[010]  
A-527-02-2016 Control of Absorbances Form - #[015]  
A-528-01-2016 Performance verification of dissolution apparatus  
A-529-01-2016 Preventative maintenance programs for laboratory equipment  
A-530-01-2016 Apparatus Suitability Prednisone Paddle method  

A-531-01-2016 Dissolution Apparatus - Eccentricity of Shafts

 
A-532-01-2016 Apparatus Suitability Salicylic Acid Basket method  
A-534-01-2016 Apparatus Suitability Salicylic Acid Paddle method  
A-536-01-2016 Apparatus Suitability Prednisone Basket method  
A-538-01-2016 Dissolution Apparatus - Routine Checking & Calibration  
A-540-01-2016 Daily Balance Calibration - #[020]  
A-542-01-2016 Monthly Analytical Balance Check - Tolerance 1.0mg  
A-545-01-2016 Monthly Analytical Balance Check - Tolerance 0.1mg  
A-580-01-2016 Reserved SOPs for specialized equipment and test methods  
A-590-01-2016 Operation of specific laboratory analytical equipment - #[030]  
A-595-01-2016 Operation of specific laboratory analytical equipment - #[040]  
A-600-01-2016 Operation of specific laboratory analytical equipment - #[050]  
   
Job Descriptions and Training  
A-605-01-2016 Using analytical SOPs & compliance program as training tools.  
A-610-01-2016 The doís and doníts of an analytical study - as a department training tool.  
A-615-01-2016 Analytical laboratory compliance staff training  
A-620-01-2016 Qualification of analytical laboratory personnel  
A-625-01-2016 Operator Certification Procedures of laboratory personnel  
A-630-01-2016 Maintenance of laboratory personnel training records  
   
Self-inspection and Auditing  
A-635-01-2016 Cross-referencing laboratory notebooks with printed reports.  
A-640-01-2016 Auditing development data in laboratory notebooks.  
A-642-01-2016 Laboratory Notebook Checklist.  
A-645-01-2016 Self inspection procedures in an analytical laboratory.  
   
Reviewing Documentation  
A-650-01-2016 Review and Auditing analytical data.  
A-655-01-2016 Auditing the Process Qualification Batch analytical data.  
A-660-01-2016 Review and Auditing the Pivotal Batch analytical data.  
A-665-01-2016 Review and Auditing Stability Batch analytical data.  
   
Closing a Study  
A-670-01-2016 Accepting and signing-off a completed analytical study.  
 


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