SOP Control
1- Indexing procedure for Microbiology SOPs. 2- Index for Microbiology SOPs.
Notebooks
1- Issue, use, and disposition of microbiological laboratory notebooks
Samples and Sampling
1- The use of sterile sampling containers. 2- Representative sampling procedures. 3- Labeling of sample containers. 4- Receipt and logging of laboratory samples. 5- Storage of samples before and after testing. 6- Storing the Microbiology study samples under refrigerated conditions prior to analysis. 7-Number of samples required for performing microbiology tests. 8- Storage time limitations of samples prior to testing
Bioburden of Starting Materials
1- Microbial testing of non active raw materials. 2- Total microbial Count specifications in Purified Water USP 3- Microbial testing in Container-Liner-Closure systems
Media
1- Labeling and expiration dating of prepared media 2- Disposition of microbiological media and samples 3- Preparation, storage and use of microbiological media.
Purified Water USP
1- Sampling sites and procedures for monitoring Purified Water USP 2- Total Microbial Count specifications in Purified Water USP 3- Microbial Limit Test specifications in Purified Water USP 4- Alert and Action limits on TMC in Purified Water USP 5- Frequency of microbial testing in Purified Water USP
In-process Controls
1- Representative sample procedures on bulk products 2- In process control on bulk products 3- Time limitations on bulk product in process controls
Finished Product Testing
1- Total microbial Count specifications in drug products. 2- Fungal Limit Test specifications in drug products. 3- Microbial Limit Test specifications in drug products. 4- Preservative efficacy testing and specifications in topical semi-solids 5- Microbial Assay testing in topical semi-solids
Laboratory Housekeeping
1- Procedures for reduction of Bioburden in the microbiological laboratory 2- The use and rotation of disinfectant swabbing solutions. 3- Prevention of contamination of media plates 4- Preparation, sterilization and storage of laboratory glassware and equipment
Culture Control
1- Procedures for receipt, storage and handling of ATCC cultures 2- Handling Certificate of Analysis for ATCC cultures 3-Limitation on transfer procedures for ATCC cultures
Test Method Control
1- Control and use of supplemental monographs in pharmacopoeial methods 2- The control of test methods #s and Edition #s in microbiology documentation. 3- Distribution of approved test method procedures 4- Validation of in-house test method procedures
Formula Control
1- Recording and checking of method calculations 2- Procedures for rounding-off recorded numbers
Investigation Reports
1- Procedures for handling abnormal or OOS results in a microbiology study. 2- Procedures for repeat testing 3- Investigation reports after repeat testing 4- Procedures for invalidating test results
Aseptic Practice
1- Periodic monitoring of laminar flow units 2- Aseptic working practice and techniques for laminar flow units
Environmental Monitoring
1- Bioburden mapping of laboratory environment 2- Bioburden mapping of manufacturing environment 3- Bioburden evaluation of manufacturing equipment 4- Bioburden sampling and evaluation of the environment air 5- The operation and use of Biotest Hycon air RCS sampler 6- Bioburden evaluation of personnel hands and clothing 7- Swabbing procedures for surface evaluation.
Chart Control
1- Routine signing and checking of temperature charts 2- Review and control of temperature and humidity recording charts.
Calibration, Validation and Qualification
1- Itemized list of microbiology laboratory equipment 2- Validation of laboratory autoclaves 3- Periodic revalidation of autoclaves and incubators. 4- Calibration schedule for microbiology laboratory instruments 5- Annual qualification program for laboratory instruments 6- Preventative maintenance programs for laboratory equipment 7- Reserved SOPs for specialized equipment and test methods
Sanitation
1- Sanitation and housekeeping requirements of incubators. 2- Good House Keeping practice in a microbiological laboratory 3- Cleaning and sanitation procedures for incubators and refrigerators 4- Garmenting procedures for microbiological personnel
Job Descriptions and Training
1- Using Microbiology SOPs and compliance program as a microbiology training tools. 2- The Do's and Don'ts of a microbiology study - as a department training tool. 3- Microbiology department compliance staff training 4- Job description of microbiology department personnel 5- Maintenance of microbiological personnel training records
Contract Laboratories
1- Auditing procedures for a contract laboratory. 2- Mail/fax auditing procedures for a contract laboratory.
Development SOP
1- Microbiology development procedures for new products.
Self-inspection and Auditing
1- Cross- referencing laboratory notebooks with computerized microbiology report sheets. 2- Auditing microbiology data in laboratory notebooks. 3- Self inspection procedures in a microbiology laboratory.
Reviewing Documentation
1- Review and auditing microbiology documentation. 2- Reporting the test results of a microbiology study.
Closing a Study
1- Accepting and signing-off a completed microbiology study.
