IAGIM - Drug Development Association

IAGIM - SOPs - Microbiological

Archive of SOPs-Microbiological

Pharmaceutical - | --Analytical - | --Microbiological - | -Stability

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350 SOPs on 3 CD's - View - PDF / (.RTF is editible)

an Example SOP and
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SOP Control  
M-005-01-2019 Indexing procedure for Microbiology SOPs.  
M-010-01-2019 Index for Microbiology SOPs.  
M-015-01-2019 Issue, use, and disposition of microbiological laboratory notebooks  
Samples and Sampling  
M-021-02-2019 The use of sterile sampling containers.  
M-025-01-2019 Representative sampling procedures.  
M-030-01-2019 Labeling of sample containers.  
M-035-01-2019 Receipt and logging of laboratory samples.  
M-040-01-2019 Storage of samples before and after testing.  
M-045-01-2019 Storing the Microbiology study samples under refrigerated conditions prior to analysis.  
M-051-02-2019 Number of samples required for performing microbiology tests.  
M-055-01-2019 Storage time limitations of samples prior to testing  
Bioburden of Starting Materials  
M-060-01-2019 Microbial testing of non active raw materials.  
M-065-01-2019 Total microbial Count specifications in Purified Water USP  
M-070-01-2019 Microbial testing in Container-Liner-Closure systems  
M-075-01-2019 Labeling and expiration dating of prepared media  
M-080-01-2019 Disposition of microbiological media and samples  
M-085-01-2019 Preparation, storage and use of microbiological media.  
Purified Water USP  
M-090-01-2019 Sampling sites and procedures for monitoring Purified Water USP  
M-095-01-2019 Total Microbial Count specifications in Purified Water USP  
M-100-02-2019 Microbial Limit Test specifications in Purified Water USP  
M-105-01-2019 Alert and Action limits on TMC in Purified Water USP  
M-110-01-2019 Frequency of microbial testing in Purified Water USP  
In-process Controls   
M-115-01-2019 Representative sample procedures on bulk products  
M-120-01-2019 In process control on bulk products  
M-125-01-2019 Time limitations on bulk product in process controls  
Finished Product Testing   
M-130-02-2019 Total microbial Count specifications in drug products.  
M-135-01-2019 Fungal Limit Test specifications in drug products.  
M-140-01-2019 Microbial Limit Test specifications in drug products.  
M-145-01-2019 Preservative efficacy testing and specifications in topical semi-solids  
M-150-01-2019 Microbial Assay testing in topical semi-solids  
Laboratory Housekeeping  
M-155-01-2019 Procedures for reduction of bioburden in the microbiological laboratory  
M-160-01-2019 The use and rotation of disinfectant swabbing solutions.  
M-165-01-2019 Prevention of contamination of media plates  
M-170-01-2019 Preparation, sterilization and storage of laboratory glassware and equipment  
Culture Control   
M-175-01-2019 Procedures for receipt, storage and handling of ATCC cultures  
M-180-01-2019 Handling Certificate of Analysis for ATCC cultures  
M-185-01-2019 Limitation on transfer procedures for ATCC cultures  
Test Method Control  
M-190-01-2019 Control and use of supplemental monographs in pharmacopoeial methods  
M-195-01-2019 The control of test methods #s and Edition #s in microbiology documentation.  
M-200-01-2019 Distribution of approved test method procedures  
M-205-01-2019 Validation of in-house test method procedures  
Formula Control  
M-210-01-2019 Recording and checking of method calculations  
M-215-01-2019 Procedures for rounding-off recorded numbers  
Investigation Reports  
M-220-01-2019 Procedures for handling abnormal or OOS results in a microbiology study.  
M-225-01-2019 Procedures for repeat testing  
M-230-01-2019 Investigation reports after repeat testing  
M-235-01-2019 Procedures for invalidating test results  
Aseptic Practice  
M-240-01-2019 Periodic monitoring of lamina flow units  
M-245-01-2019 Aseptic working practice and techniques for laminar flow units  
Environmental Monitoring  
M-250-01-2019 Bioburden mapping of laboratory environment  
M-255-01-2019 Bioburden mapping of manufacturing environment  
M-260-01-2019 Bioburden evaluation of manufacturing equipment  
M-265-01-2019 Bioburden sampling and evaluation of the environment air  
M-270-01-2019 The operation and use of Biotest Hycon air RCS sampler  
M-275-01-2019 Bioburden evaluation of personnel hands and clothing  
M-280-01-2019 Swabbing procedures for surface evaluation.  
Chart Control   
M-290-01-2019 Routine signing and checking of temperature charts  
M-295-01-2019 Review and control of temperature and humidity recording charts.  
Calibration , Validation and Qualification  
M-300-01-2019 Itemized list of microbiology laboratory equipment  
M-305-01-2019 Validation of laboratory autoclaves  
M-310-01-2019 Periodic revalidation of autoclaves and incubators.  
M-315-01-2019 Calibration schedule for microbiology laboratory instruments  
M-320-01-2019 Annual qualification program for laboratory instruments  
M-325-01-2019 Preventative maintenance programs for laboratory equipment  
M-330-01-2019 Reserved SOPs for specialized equipment and test methods  
M-335-01-2019 Sanitation and housekeeping requirements of incubators.  
M-340-01-2019 Good House Keeping practice in a microbiological laboratory  
M-345-01-2019 Cleaning and sanitation procedures for incubators and refrigerators  
M-350-01-2019 Garmenting procedures for microbiological personnel  
Job Descriptions and Training   
M-355-01-2019 Using Microbiology SOPs and compliance program as a microbiology training tools.  
M-360-01-2019 The Do's and Don'ts of a microbiology study - as a department training tool.  
M-365-01-2019 Microbiology department compliance staff training  
M-370-01-2019 Job description of microbiology department personnel  
M-375-01-2019 Maintenance of microbiological personnel training records  
Contract Laboratories  
M-380-01-2019 Auditing procedures for a contract laboratory.  
M-385-01-2019 Mail/fax auditing procedures for a contract laboratory.  
Development SOP
M-390-01-2019 Microbiology development procedures for new products.  
Self-inspection and Auditing   
M-395-01-2019 Cross- referencing laboratory notebooks with computerized microbiology report sheets.  
M-400-01-2019 Auditing microbiology data in laboratory notebooks.  
M-405-01-2019 Self inspection procedures in a microbiology laboratory.  
Reviewing Documentation  
M-410-01-2019 Review and auditing microbiology documentation.  
M-415-01-2019 Reporting the test results of a microbiology study.  
Closing a Study  
M-420-01-2019 Accepting and signing-off a completed microbiology study.  
Available to IAGIM members via IAGIM Center -
24 SOPs and Validation Protocols via IAGIM Online

Download an Example SOP and
One - just to see

Pharmaceutical - -| --Analytical - - | --Microbiological - | -Stability


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