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Sops Index

This document contains an index of standard operating procedures (SOPs) for a microbiology laboratory. It includes SOPs related to sampling procedures, testing of raw materials, media preparation, purified water and environmental monitoring, in-process and finished product testing, laboratory housekeeping, quality control, equipment operation and maintenance, and documentation practices. In total, it indexes over 100 individual SOPs covering all aspects of microbiological testing and laboratory operations.

Uploaded by

Ibrahim Issa
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
272 views

Sops Index

This document contains an index of standard operating procedures (SOPs) for a microbiology laboratory. It includes SOPs related to sampling procedures, testing of raw materials, media preparation, purified water and environmental monitoring, in-process and finished product testing, laboratory housekeeping, quality control, equipment operation and maintenance, and documentation practices. In total, it indexes over 100 individual SOPs covering all aspects of microbiological testing and laboratory operations.

Uploaded by

Ibrahim Issa
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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.

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