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Non members 330 + Key Selected e-SOPs on CD - View

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SOP Control   
M-005-02-2016 Indexing procedure for Microbiology SOPs.  
M-010-02-2016 Index for Microbiology SOPs.  
M-015-02-2016 Issue, use, and disposition of microbiological laboratory notebooks  
Samples and Sampling  
M-020-02-2016 The use of sterile sampling containers.  
M-025-02-2016 Representative sampling procedures.  
M-030-02-2016 Labeling of sample containers.  
M-035-02-2016 Receipt and logging of laboratory samples.  
M-040-02-2016 Storage of samples before and after testing.  
M-045-02-2016 Storing the Microbiology study samples under refrigerated conditions prior to analysis.  
M-050-02-2016 Number of samples required for performing microbiology tests.  
M-055-02-2016 Storage time limitations of samples prior to testing  
Bioburden of Starting Materials  
M-060-02-2016 Microbial testing of non active raw materials.  
M-065-02-2016 Total microbial Count specifications in Purified Water USP  
M-070-02-2016 Microbial testing in Container-Liner-Closure systems  
M-075-02-2016 Labeling and expiration dating of prepared media  
M-080-02-2016 Disposition of microbiological media and samples  
M-085-02-2016 Preparation, storage and use of microbiological media.  
Purified Water USP  
M-090-02-2016 Sampling sites and procedures for monitoring Purified Water USP  
M-095-02-2016 Total Microbial Count specifications in Purified Water USP  
M-100-02-2016 Microbial Limit Test specifications in Purified Water USP  
M-105-02-2016 Alert and Action limits on TMC in Purified Water USP  
M-110-02-2016 Frequency of microbial testing in Purified Water USP  
In-process Controls   
M-115-02-2016 Representative sample procedures on bulk products  
M-120-02-2016 In process control on bulk products  
M-125-02-2016 Time limitations on bulk product in process controls  
Finished Product Testing   
M-130-02-2016 Total microbial Count specifications in drug products.  
M-135-02-2016 Fungal Limit Test specifications in drug products.  
M-140-02-2016 Microbial Limit Test specifications in drug products.  
M-145-02-2016 Preservative efficacy testing and specifications in topical semi-solids  
M-150-02-2016 Microbial Assay testing in topical semi-solids  
Laboratory Housekeeping  
M-155-02-2016 Procedures for reduction of bioburden in the microbiological laboratory  
M-160-02-2016 The use and rotation of disinfectant swabbing solutions.  
M-165-02-2016 Prevention of contamination of media plates  
M-170-02-2016 Preparation, sterilization and storage of laboratory glassware and equipment  
Culture Control  
M-175-02-2016 Procedures for receipt, storage and handling of ATCC cultures  
M-180-02-2016 Handling Certificate of Analysis for ATCC cultures  
M-185-02-2016 Limitation on transfer procedures for ATCC cultures  
Test Method Control   
M-190-02-2016 Control and use of supplemental monographs in pharmacopoeial methods  
M-195-02-2016 The control of test methods #s and Edition #s in microbiology documentation.  
M-200-02-2016 Distribution of approved test method procedures  
M-205-02-2016 Validation of in-house test method procedures  
Formula Control  
M-210-02-2016 Recording and checking of method calculations  
M-215-02-2016 Procedures for rounding-off recorded numbers  
Investigation Reports  
M-220-02-2016 Procedures for handling abnormal or OOS results in a microbiology study.  
M-225-02-2016 Procedures for repeat testing  
M-230-02-2016 Investigation reports after repeat testing  
M-235-02-2016 Procedures for invalidating test results  
Aseptic Practice   
M-240-02-2016 Periodic monitoring of lamina flow units  
M-245-02-2016 Aseptic working practice and techniques for laminar flow units  
Environmental Monitoring   
M-250-02-2016 Bioburden mapping of laboratory environment  
M-255-02-2016 Bioburden mapping of manufacturing environment  
M-260-02-2016 Bioburden evaluation of manufacturing equipment  
M-265-02-2016 Bioburden sampling and evaluation of the environment air  
M-270-02-2016 The operation and use of Biotest Hycon air RCS sampler  
M-275-02-2016 Bioburden evaluation of personnel hands and clothing  
M-280-02-2016 Swabbing procedures for surface evaluation.  
Chart Control   
M-290-02-2016 Routine signing and checking of temperature charts  
M-295-02-2016 Review and control of temperature and humidity recording charts.  
Calibration, Validation and Qualification  
M-300-02-2016 Itemized list of microbiology laboratory equipment  
M-305-02-2016 Validation of laboratory autoclaves  
M-310-02-2016 Periodic revalidation of autoclaves and incubators.  
M-315-02-2016 Calibration schedule for microbiology laboratory instruments  
M-320-02-2016 Annual qualification program for laboratory instruments  
M-325-02-2016 Preventative maintenance programs for laboratory equipment  
M-330-02-2016 Reserved SOPs for specialized equipment and test methods  
M-335-02-2016 Sanitation and housekeeping requirements of incubators.  
M-340-02-2016 Good House Keeping practice in a microbiological laboratory  
M-345-02-2016 Cleaning and sanitation procedures for incubators and refrigerators  
M-350-02-2016 Garmenting procedures for microbiological personnel  
Job Descriptions and Training   
M-355-02-2016 Using Microbiology SOPs and compliance program as a microbiology training tools.  
M-360-02-2016 The Do's and Don'ts of a microbiology study - as a department training tool.  
M-365-02-2016 Microbiology department compliance staff training  
M-370-02-2016 Job description of microbiology department personnel  
M-375-02-2016 Maintenance of microbiological personnel training records  
Contract Laboratories   
M-380-02-2016 Auditing procedures for a contract laboratory.  
M-385-02-2016 Mail/fax auditing procedures for a contract laboratory.  
Development SOP
M-390-02-2016 Microbiology development procedures for new products.  
Self-inspection and Auditing   
M-395-02-2016 Cross- referencing laboratory notebooks with computerized microbiology report sheets.  
M-400-02-2016 Auditing microbiology data in laboratory notebooks.  
M-405-02-2016 Self inspection procedures in a microbiology laboratory.  
Reviewing Documentation   
M-410-02-2016 Review and auditing microbiology documentation.  
M-415-02-2016 Reporting the test results of a microbiology study.  
Closing a Study  
M-420-02-2016 Accepting and signing-off a completed microbiology study. 81 SOP


330 + Key Selected e-SOPs on CD - View
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