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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 One - just to see
" High Quality Cost Effective Drug Development & Manufacturing
Excellence World Wide "
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| SOP Control | |
| M-005-01-2010 Indexing procedure for Microbiology
SOPs. |
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| M-010-01-2010 Index for Microbiology SOPs. |
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| Notebooks
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| M-015-01-2010 Issue, use,
and disposition of microbiological laboratory notebooks | |
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| Samples
and Sampling | |
| M-020-01-2010 The use of sterile sampling containers. | |
| M-025-01-2010 Representative sampling procedures. | |
| M-030-01-2010 Labeling of sample containers. | |
| M-035-01-2010 Receipt and logging of laboratory samples. | |
| M-040-01-2010 Storage of samples before and after testing. | |
| M-045-01-2010 Storing the Microbiology study samples under
refrigerated conditions prior to analysis. | |
| M-050-01-2010 Number of samples required for performing microbiology
tests. | |
| M-055-01-2010 Storage time limitations of samples prior to testing | |
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| Bioburden of Starting
Materials |
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| M-060-01-2010 Microbial testing of non active raw materials. | |
| M-065-01-2010 Total microbial Count specifications in Purified
Water USP | |
| M-070-01-2010 Microbial
testing in Container-Liner-Closure systems | |
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| Media
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| M-075-01-2010 Labeling
and expiration dating of prepared media | |
| M-080-01-2010 Disposition of microbiological media and samples | |
| M-085-01-2010 Preparation, storage and use of microbiological
media. | |
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| Purified Water USP | |
| M-090-01-2010 Sampling sites and procedures
for monitoring Purified Water USP | |
| M-095-01-2010 Total Microbial Count specifications in Purified
Water USP | |
| M-100-02-2010 Microbial
Limit Test specifications in Purified Water USP | |
| M-105-01-2010 Alert and Action limits on TMC in Purified
Water USP | |
| M-110-01-2010 Frequency
of microbial testing in Purified Water USP | |
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| In-process
Controls | |
| M-115-01-2010 Representative sample procedures on bulk products
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| M-120-01-2010 In process control
on bulk products | |
| M-125-01-2010 Time limitations on bulk product in process controls | |
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| Finished
Product Testing | |
| M-130-02-2010 Total microbial Count specifications in drug
products. | |
| M-135-01-2010 Fungal
Limit Test specifications in drug products. | |
| M-140-01-2010 Microbial Limit Test specifications in drug products.
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| M-145-01-2010 Preservative
efficacy testing and specifications in topical semi-solids | |
| M-150-01-2010 Microbial Assay testing in topical semi-solids
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| Laboratory Housekeeping | |
| M-155-01-2010 Procedures for reduction of bioburden in the
microbiological laboratory | |
| M-160-01-2010 The use and rotation of disinfectant swabbing solutions. | |
| M-165-01-2010 Prevention of contamination of media plates
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| M-170-01-2010 Preparation,
sterilization and storage of laboratory glassware and equipment | |
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| Culture
Control | |
| M-175-01-2010 Procedures for receipt, storage and handling
of ATCC cultures | |
| M-180-01-2010 Handling Certificate of Analysis for ATCC cultures | |
| M-185-01-2010 Limitation on transfer procedures for ATCC
cultures | |
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| Test Method Control | |
| M-190-01-2010 Control and use of supplemental monographs
in pharmacopoeial methods | |
| M-195-01-2010 The control of test methods #s and Edition #s in microbiology documentation. | |
| M-200-01-2010 Distribution of approved test method procedures | |
| M-205-01-2010 Validation of in-house test method procedures | |
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| Formula
Control | |
| M-210-01-2010 Recording and checking of method calculations | |
| M-215-01-2010 Procedures for rounding-off recorded numbers | |
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| Investigation
Reports | |
| M-220-01-2010 Procedures for handling abnormal or OOS results in a microbiology study. | |
| M-225-01-2010 Procedures for repeat testing | |
| M-230-01-2010 Investigation reports after repeat testing | |
| M-235-01-2010 Procedures for invalidating test results | |
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| Aseptic
Practice | |
| M-240-01-2010 Periodic monitoring of lamina flow units | |
| M-245-01-2010 Aseptic working practice and techniques for laminar flow units | |
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| Environmental
Monitoring | |
| M-250-01-2010 Bioburden mapping of laboratory environment | |
| M-255-01-2010 Bioburden mapping of manufacturing environment | |
| M-260-01-2010 Bioburden evaluation of manufacturing equipment | |
| M-265-01-2010 Bioburden sampling and evaluation of the environment
air | |
| M-270-01-2010 The operation
and use of Biotest Hycon air RCS sampler | |
| M-275-01-2010 Bioburden evaluation of personnel hands and clothing | |
| M-280-01-2010 Swabbing procedures for surface evaluation.
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| Chart Control
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| M-290-01-2010 Routine
signing and checking of temperature charts | |
| M-295-01-2010 Review and control of temperature and humidity recording
charts. | |
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| Calibration , Validation and
Qualification | |
| M-300-01-2010 Itemized list of microbiology laboratory equipment | |
| M-305-01-2010 Validation of laboratory autoclaves | |
| M-310-01-2010 Periodic revalidation of autoclaves and incubators.
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| M-315-01-2010 Calibration
schedule for microbiology laboratory instruments | |
| M-320-01-2010 Annual qualification program for laboratory
instruments | |
| M-325-01-2010 Preventative maintenance programs for laboratory equipment | |
| M-330-01-2010 Reserved SOPs for specialized equipment and
test methods | |
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| Sanitation | |
| M-335-01-2010 Sanitation and housekeeping requirements of
incubators. | |
| M-340-01-2010 Good
House Keeping practice in a microbiological laboratory | |
| M-345-01-2010 Cleaning and sanitation procedures for incubators
and refrigerators | |
| M-350-01-2010 Garmenting procedures for microbiological personnel | |
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| Job
Descriptions and Training | |
| M-355-01-2010 Using Microbiology SOPs and compliance program
as a microbiology training tools. | |
| M-360-01-2010 The Do's and Don'ts of a microbiology study - as a department training tool. | |
| M-365-01-2010 Microbiology department compliance staff training
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| M-370-01-2010 Job description
of microbiology department personnel | |
| M-375-01-2010 Maintenance of microbiological personnel training records | |
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| Contract
Laboratories | |
| M-380-01-2010 Auditing procedures for a contract laboratory. | |
| M-385-01-2010 Mail/fax auditing procedures for a contract
laboratory. | |
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Development SOP
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| M-390-01-2010 Microbiology
development procedures for new products. | |
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| Self-inspection and Auditing
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| M-395-01-2010 Cross-
referencing laboratory notebooks with computerized microbiology report sheets.
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| M-400-01-2010 Auditing microbiology
data in laboratory notebooks. | |
| M-405-01-2010 Self inspection procedures in a microbiology laboratory. | |
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| Reviewing
Documentation | |
| M-410-01-2010 Review and auditing microbiology documentation. | |
| M-415-01-2010 Reporting the test results of a microbiology
study. | |
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| Closing a Study | |
| M-420-01-2010 Accepting and signing-off a completed microbiology
study. | |