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IAGIM Association
Members - Receive 3 Free SOP on CDs (PDF)
350 SOPs on 3 CD's - View
- PDF / (.RTF is editible)
Download
an example SOP and another
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" High Quality Cost
Effective Drug Development & Manufacturing Excellence World
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| Index No SOPs |
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| A-001-01-2019 Indexing procedure for analytical
SOPs. |
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| A-010-01-2019 Index of analytical SOPs. |
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| A-012-01-2019 Authorization signatures for analytical
SOPs. |
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| A-015-01-2019 Numbering and format of analytical
SOPs. |
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| A-021-02-2019 Circulation of analytical SOPs. |
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| A-025-01-2019 Annual Review of analytical SOPs. |
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| A-030-01-2019 Reserved. |
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Development
Notebooks
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| A-035-01-2019 Issue and use of analytical development
notebooks |
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| A-040-01-2019 Signing procedures for analytical
notebooks |
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| A-045-01-2019 Entering raw data in laboratory
notebooks |
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| A-051-02-2019 Using USP terminology in analytical
methods |
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| A-055-01-2019 Verifying analytical calculations
performed by (in-house) computer programs |
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| A-060-01-2019 Release of Results from the Analytical
R&D Laboratories. |
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| A-062-02-2019 Reviewer Checklist . |
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| Auditing |
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| A-065-01-2019 Review and auditing of analytical
laboratory notebooks |
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| A-070-01-2019 Correction procedures in laboratory
notebooks |
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| A-075-01-2019 Archiving of laboratory notebooks |
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| A-080-01-2019 Laboratory Note Book Checklist. |
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| Development Quality
Assurance |
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| A-085-01-2019 Procedures for Analytical Change
Control |
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| A-090-01-2019 Reserved. |
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| Incoming Samples |
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| A-095-01-2019 General Analytical Sample Preparation. |
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| A-100-01-2019 Receipt and logging-in of analytical
laboratory samples |
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| A-105-01-2019 Storage of samples prior to testing
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| A-110-01-2019 Storage time limits of samples prior
to testing. |
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| A-115-01-2019 Disposition of tested laboratory
samples (including time limits). |
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| A-120-01-2019 Reserved. |
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| Reagent and Solutions |
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| A-125-01-2019 Handling and preparation of analytical
standards |
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| A-130-01-2019 Handling and preparation of volumetric
solutions |
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| A-135-01-2019 Labeling requirements of reagents
and solutions |
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| A-140-01-2019 Preparation and storage of analytical
glassware |
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| A-145-01-2019 Reserved. |
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| Test Methods |
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| A-150-01-2019 Availability and control of approved
test methods. |
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| A-155-01-2019 Updating Pharmacopeial methods with
supplemental monographs. |
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| A-160-01-2019 Abbreviated Raw Materials testing
Procedures. |
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| A-165-01-2019 Approval signatures for Raw materials
and Approved suppliers. |
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| A-170-01-2019 Retesting Procedures. |
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| Calculations |
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| A-175-01-2019 Recording and checking of method
calculations |
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| A-180-01-2019 Procedures for rounding off analytical
numbers |
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| Active Materials |
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| A-190-01-2019 Active Drug Substances for Generic
Drugs |
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| A-195-01-2019 Developing Product Formula with
approved Actives |
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| A-200-01-2019 Development Inventory Records for
the Active Drug Substance |
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| A-205-01-2019 Reserved. |
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| Drug Substance |
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| A-210-01-2019 Drug substance impurity assays |
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| A-215-01-2019 Drug substance impurities profiles |
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| A-220-01-2019 Drug substance specifications |
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| A-225-01-2019 Drug substance approval procedures |
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| A-235-01-2019 Drug substance approved suppliers
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| The
Reference Listed Drug |
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| A-240-01-2019 Reserved |
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| A-245-01-2019 Testing the Reference Listed Drug
(RLD) |
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| Drug Product |
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| A-250-01-2019 Drug substance impurity assays |
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| A-255-01-2019 Drug substance impurities profiles
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| A-260-01-2019 Drug substance Specifications |
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| A-265-01-2019 Limit test on impurities |
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| A-270-01-2019 Validation of limit tests for impurities |
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| A-272-01-2019 Validation of Assay and/or Impurities
Determination |
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| A-275-01-2019 Assay determination by HPLC and
GC methods. |
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| A-276-02-2019 Assay determination by HPLC and
GC methods -Details. |
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| Container-liner-closure
Systems |
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| A-280-01-2019 Testing Container-Liner-Closure
systems for Generic Development |
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| Sample Preparation |
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| A-290-01-2019 General analytical sample preparation |
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| A-295-01-2019 Number of samples and injections
for assays |
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| A-300-01-2019 Standards and system suitability
for HPLC testing |
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| A-304-01-2019 Working and Impurity Standards -
Use and Qualification |
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| A-305-01-2019 Working with Reference Standards
and In-house Standards. |
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| Validation |
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| A-310-01-2019 Using ID numbers for identifying
laboratory instrumentation. |
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| A-315-01-2019 Validation of stability-indicating
(S-I) methods |
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| A-320-01-2019 Validation of in-house analytical
methods |
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| A-325-01-2019 Using stability indicating (S-I)
methods |
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| A-335-01-2019 Analytical methods not requiring
(full) validation |
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| A-340-01-2019 Contents of an analytical validation
protocol |
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| A-345-01-2019 Standardizing and transferring S-I
methods and assay validations. |
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| A-350-01-2019 Change Control Procedures. |
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| Contract Laboratories |
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| A-355-01-2019 Auditing procedures for a contract
analytical laboratory. |
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| A-365-01-2019 Mail/fax auditing procedures for
a contract laboratory. |
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| Process Qualification
Batch (Scaled-up) |
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| A-375-01-2019 Process Qualification Batch analytical
requirements |
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| A-380-01-2019 Side-by-side analytical
comparison for process qualification & pivotal batch |
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| A-385-01-2019 Reserved. |
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| Pivotal Batch |
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| A-390-01-2019 Pivotal Batch analytical requirements |
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| A-395-01-2019 Do’s and Don’ts when preparing for
pivotal testing |
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| A-400-01-2019 Checklist for pivotal batch analytical
documentation |
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| A-405-01-2019 Side-by-side analytical comparison
for pivotal and validation batch |
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| Investigations |
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| A-415-01-2019 Procedures for handling OOS results |
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| A-420-01-2019 Procedures for repeat testing (using
two stages) |
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| A-425-01-2019 Procedures for invalidating test
results and graphs |
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| A-430-01-2019 Investigation reports after repeat
testing |
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| A-435-01-2019 Evaluation of Significant Change
in Stability Test Results. |
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| Analytical Development
Reports |
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| A-440-01-2019 Checklist for an analytical development
report |
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| A-445-01-2019 Analytical Development Reports |
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| A-448-01-2019 Preparing a standard Certificate
of Analysis |
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| Analytical Transfer
Documentation (TTDs) |
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| A-450-01-2019 Check list of an analytical TTD
file |
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| A-455-01-2019 Analytical transfer from development
to QC of mnf. facility. |
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| A-460-01-2019 Change Control Form. |
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| Chart Control |
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| A-465-01-2019 Routine signing and checking of
temperature recording charts |
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| A-470-01-2019 Review & control of temperature
& humidity recording charts. |
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| A-475-01-2019 Handling of Instrument Graphs, Charts
and Print-outs |
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| Sanitation |
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| A-480-01-2019 Good House Keeping Practice in an
analytical laboratory. |
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| A-485-01-2019 Cleaning and sanitation procedures
for laboratory equipment. |
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| A-490-01-2019 Garmenting procedures for laboratory
personnel |
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| Calibration , Validation
and Qualification |
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| A-495-01-2019 Itemized list of laboratory equipment |
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| A-500-01-2019 IQOQ requirements for laboratory
equipment |
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| A-505-01-2019 Calibration requirements for laboratory
equipment |
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| A-510-01-2019 Corrective action procedures for
out-of-calibration instrumentation. |
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| A-515-01-2019 Operational Instructions for laboratory
equipment |
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| A-516-01-2019 Calibration of pH meters |
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| A-517-01-2019 Instrument performance checks protocol
calibration of pH meter electrode system |
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| A-518-02-2019 Calibration of pH meters
- Detailed |
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| A-519-01-2019 Performance Checks GC Integrator
HP 3396 Series II, HP 3393-A Varian 4270 |
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| A-520-01-2019 Annual qualification program for
laboratory equipment |
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| A-524-01-2019 Performance
verification of Bausch & Lomb and Milton Roy spectrophotometers |
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| A-525-01-2019 Spectronic Standards
- Test Calibration Form # [001] |
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| A-526-01-2019 Wavelength Accuracy Form - # [005] |
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| A-527-01-2019 Control of Absorbances Form - #[010] |
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| A-527-02-2019 Control of Absorbances Form - #[015] |
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| A-528-01-2019 Performance verification of dissolution
apparatus |
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| A-529-01-2019 Preventative maintenance programs
for laboratory equipment |
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| A-530-01-2019 Apparatus Suitability Prednisone
Paddle method |
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A-531-01-2019 Dissolution Apparatus - Eccentricity
of Shafts
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| A-532-01-2019 Apparatus Suitability Salicylic
Acid Basket method |
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| A-534-01-2019 Apparatus Suitability Salicylic
Acid Paddle method |
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| A-536-01-2019 Apparatus Suitability Prednisone
Basket method |
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| A-538-01-2019 Dissolution Apparatus - Routine
Checking & Calibration |
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| A-540-01-2019 Daily Balance Calibration - #[020]
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| A-542-01-2019 Monthly Analytical Balance Check
- Tolerance 1.0mg |
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| A-545-01-2019 Monthly Analytical Balance Check
- Tolerance 0.1mg |
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| A-580-01-2019 Reserved SOPs for specialized equipment
and test methods |
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| A-590-01-2019 Operation of specific laboratory
analytical equipment - #[030] |
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| A-595-01-2019 Operation of specific laboratory
analytical equipment - #[040] |
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| A-600-01-2019 Operation of specific laboratory
analytical equipment - #[050] |
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| Job Descriptions
and Training |
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| A-605-01-2019 Using analytical SOPs & compliance
program as training tools. |
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| A-610-01-2019 The do’s and don’ts of an analytical
study - as a department training tool. |
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| A-615-01-2019 Analytical laboratory compliance
staff training |
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| A-620-01-2019 Qualification of analytical laboratory
personnel |
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| A-625-01-2019 Operator Certification Procedures
of laboratory personnel |
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| A-630-01-2019 Maintenance of laboratory personnel
training records |
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| Self-inspection
and Auditing |
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| A-635-01-2019 Cross-referencing laboratory notebooks
with printed reports. |
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| A-640-01-2019 Auditing development data in laboratory
notebooks. |
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| A-642-01-2019 Laboratory Notebook Checklist. |
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| A-645-01-2019 Self inspection procedures in an
analytical laboratory. |
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| Reviewing Documentation |
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| A-650-01-2019 Review and Auditing analytical data. |
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| A-655-01-2019 Auditing the Process Qualification
Batch analytical data. |
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| A-660-01-2019 Review and Auditing the Pivotal
Batch analytical data. |
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| A-665-01-2019 Review and Auditing Stability Batch
analytical data. |
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| Closing a Study |
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| A-670-01-2019 Accepting and signing-off a completed
analytical study. |
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