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