DRUG DEVELOPMENT SOPs
" High Quality Cost Effective Drug Development & Manufacturing Excellence World Wide "... .
Archive of SOPs- MICROBIOLOGICAL
Non members 330 + Key Selected e-SOPs on CD - View
DRUG DEVELOPMENT SOPs
" High Quality Cost Effective Drug Development
& Manufacturing Excellence World Wide "... .
Archive of SOPs- MICROBIOLOGICAL
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. | |
| Notebooks | |
| 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 | |
| Media | |
| 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 | |
| Sanitation | |
| 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 |
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| 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 |
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