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
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 One - Just to See - |
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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 Do’s and Don’ts 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 | |
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A-531-01-2016 Dissolution Apparatus - Eccentricity of Shafts |
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| 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 do’s and don’ts 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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