SEARCH
IAGIM - Drug Development Association

IAGIM - SOPs - Microbiological
 


DRUG
-- DEVELOPMENT
--SOPs
.
Archive of SOPs-Microbiological

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

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
One - just to see

" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "

 
   
SOP Control  
M-005-01-2016 Indexing procedure for Microbiology SOPs.  
M-010-01-2016 Index for Microbiology SOPs.  
   
Notebooks  
M-015-01-2016 Issue, use, and disposition of microbiological laboratory notebooks  
   
Samples and Sampling  
M-021-02-2016 The use of sterile sampling containers.  
M-025-01-2016 Representative sampling procedures.  
M-030-01-2016 Labeling of sample containers.  
M-035-01-2016 Receipt and logging of laboratory samples.  
M-040-01-2016 Storage of samples before and after testing.  
M-045-01-2016 Storing the Microbiology study samples under refrigerated conditions prior to analysis.  
M-051-02-2016 Number of samples required for performing microbiology tests.  
M-055-01-2016 Storage time limitations of samples prior to testing  
   
Bioburden of Starting Materials  
M-060-01-2016 Microbial testing of non active raw materials.  
M-065-01-2016 Total microbial Count specifications in Purified Water USP  
M-070-01-2016 Microbial testing in Container-Liner-Closure systems  
   
Media   
M-075-01-2016 Labeling and expiration dating of prepared media  
M-080-01-2016 Disposition of microbiological media and samples  
M-085-01-2016 Preparation, storage and use of microbiological media.  
   
Purified Water USP  
M-090-01-2016 Sampling sites and procedures for monitoring Purified Water USP  
M-095-01-2016 Total Microbial Count specifications in Purified Water USP  
M-100-02-2016 Microbial Limit Test specifications in Purified Water USP  
M-105-01-2016 Alert and Action limits on TMC in Purified Water USP  
M-110-01-2016 Frequency of microbial testing in Purified Water USP  
   
In-process Controls   
M-115-01-2016 Representative sample procedures on bulk products  
M-120-01-2016 In process control on bulk products  
M-125-01-2016 Time limitations on bulk product in process controls  
   
Finished Product Testing   
M-130-02-2016 Total microbial Count specifications in drug products.  
M-135-01-2016 Fungal Limit Test specifications in drug products.  
M-140-01-2016 Microbial Limit Test specifications in drug products.  
M-145-01-2016 Preservative efficacy testing and specifications in topical semi-solids  
M-150-01-2016 Microbial Assay testing in topical semi-solids  
   
Laboratory Housekeeping  
M-155-01-2016 Procedures for reduction of bioburden in the microbiological laboratory  
M-160-01-2016 The use and rotation of disinfectant swabbing solutions.  
M-165-01-2016 Prevention of contamination of media plates  
M-170-01-2016 Preparation, sterilization and storage of laboratory glassware and equipment  
   
Culture Control   
M-175-01-2016 Procedures for receipt, storage and handling of ATCC cultures  
M-180-01-2016 Handling Certificate of Analysis for ATCC cultures  
M-185-01-2016 Limitation on transfer procedures for ATCC cultures  
   
Test Method Control  
M-190-01-2016 Control and use of supplemental monographs in pharmacopoeial methods  
M-195-01-2016 The control of test methods #s and Edition #s in microbiology documentation.  
M-200-01-2016 Distribution of approved test method procedures  
M-205-01-2016 Validation of in-house test method procedures  
   
Formula Control  
M-210-01-2016 Recording and checking of method calculations  
M-215-01-2016 Procedures for rounding-off recorded numbers  
   
Investigation Reports  
M-220-01-2016 Procedures for handling abnormal or OOS results in a microbiology study.  
M-225-01-2016 Procedures for repeat testing  
M-230-01-2016 Investigation reports after repeat testing  
M-235-01-2016 Procedures for invalidating test results  
   
Aseptic Practice  
M-240-01-2016 Periodic monitoring of lamina flow units  
M-245-01-2016 Aseptic working practice and techniques for laminar flow units  
   
Environmental Monitoring  
M-250-01-2016 Bioburden mapping of laboratory environment  
M-255-01-2016 Bioburden mapping of manufacturing environment  
M-260-01-2016 Bioburden evaluation of manufacturing equipment  
M-265-01-2016 Bioburden sampling and evaluation of the environment air  
M-270-01-2016 The operation and use of Biotest Hycon air RCS sampler  
M-275-01-2016 Bioburden evaluation of personnel hands and clothing  
M-280-01-2016 Swabbing procedures for surface evaluation.  
   
Chart Control   
M-290-01-2016 Routine signing and checking of temperature charts  
M-295-01-2016 Review and control of temperature and humidity recording charts.  
   
Calibration , Validation and Qualification  
M-300-01-2016 Itemized list of microbiology laboratory equipment  
M-305-01-2016 Validation of laboratory autoclaves  
M-310-01-2016 Periodic revalidation of autoclaves and incubators.  
M-315-01-2016 Calibration schedule for microbiology laboratory instruments  
M-320-01-2016 Annual qualification program for laboratory instruments  
M-325-01-2016 Preventative maintenance programs for laboratory equipment  
M-330-01-2016 Reserved SOPs for specialized equipment and test methods  
   
Sanitation  
M-335-01-2016 Sanitation and housekeeping requirements of incubators.  
M-340-01-2016 Good House Keeping practice in a microbiological laboratory  
M-345-01-2016 Cleaning and sanitation procedures for incubators and refrigerators  
M-350-01-2016 Garmenting procedures for microbiological personnel  
   
Job Descriptions and Training   
M-355-01-2016 Using Microbiology SOPs and compliance program as a microbiology training tools.  
M-360-01-2016 The Do's and Don'ts of a microbiology study - as a department training tool.  
M-365-01-2016 Microbiology department compliance staff training  
M-370-01-2016 Job description of microbiology department personnel  
M-375-01-2016 Maintenance of microbiological personnel training records  
   
Contract Laboratories  
M-380-01-2016 Auditing procedures for a contract laboratory.  
M-385-01-2016 Mail/fax auditing procedures for a contract laboratory.  
   
Development SOP
 
M-390-01-2016 Microbiology development procedures for new products.  
   
Self-inspection and Auditing   
M-395-01-2016 Cross- referencing laboratory notebooks with computerized microbiology report sheets.  
M-400-01-2016 Auditing microbiology data in laboratory notebooks.  
M-405-01-2016 Self inspection procedures in a microbiology laboratory.  
   
Reviewing Documentation  
M-410-01-2016 Review and auditing microbiology documentation.  
M-415-01-2016 Reporting the test results of a microbiology study.  
   
Closing a Study  
M-420-01-2016 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
Another
One - just to see

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


IAGIM ONLINE LOGIN
E-mailPassword


| Shipping |
By FastTrack | Using Credit Cards | Making Payments | Global Agents | Data Protection |
|
Fast Service | PayPal | Press Reports |

Copyright LIG © 2015/16 Locum International Inc. All Rights Reserved.
Read our Terms & Conditions of Use

CONTACT - | - - USA 24 x 7 : - 1-561-865-6147 - |