Histology and cytology testing SOPs (Standard Operating Procedures) are guidelines that describe the steps to be followed when processing, staining, and interpreting histological and cytological specimens. These procedures are designed to ensure that accurate and consistent results are obtained from the specimens, and that potential errors are minimized. The SOPs may cover all aspects of the process, from specimen collection to final interpretation, and typically include information on equipment, reagents, safety, and quality control measures. By following established SOPs, laboratories can ensure that their histology and cytology testing is performed in a standardized and reproducible manner.

Histology and Cytology Testing SOPs: 15 Essential Steps for Accurate Results

Here are some general guidelines for developing histology and cytology testing SOPs:

1. Purpose and Scope: Begin by clearly defining the purpose of the SOP and its scope. Specify the types of tissues or cells that will be tested, the procedures to be followed, and the expected outcomes.
2. Sample collection: SOPs should specify the appropriate collection methods and storage conditions for samples to ensure that they remain viable for testing.
3. Sample preparation: SOPs should provide detailed instructions on how to prepare the samples for testing, including fixation, embedding, and sectioning procedures.
4. Equipment and Materials: SOPs should include a list of equipment and materials required for histology and cytology testing, including the specifications for each item.
5. Sample Processing: In this step, the specimens are processed through a series of steps to create thin, stained slides for examination under the microscope.
6. Staining protocols: SOPs should specify the type of stains to be used, the staining procedures, and the interpretation of results.
7. Microscopic examination: Specify the criteria for examining samples under a microscope, such as magnification levels, identification of cells or structures, and interpretation of results.
8. Revision and review: SOPs should be regularly reviewed and revised to ensure that they remain current and effective.
9. Quality control: SOPs should include measures to ensure quality control, such as the use of positive and negative controls, regular calibration of equipment, and regular review of results by trained professionals.
10. Reporting and documentation: Determine how results will be reported and documented, including data entry, report formatting, and archiving of results and samples.
11. Data management: SOPs should include procedures for data management, including data entry, storage, and retrieval, as well as procedures for archiving and disposing of samples.
12. Safety protocols: SOPs should include safety protocols, such as the use of personal protective equipment (PPE), disposal of hazardous materials, and proper handling of sharps.
13. Equipment maintenance: SOPs should include procedures for regular maintenance and calibration of equipment used in testing.
14. Training and competency: SOPs should include requirements for training and competency assessments for staff involved in the testing process.
15. Record keeping: SOPs should specify the requirements for record keeping, including the types of records that need to be kept and the retention period.

It is essential to consult with experts in the field and adhere to relevant regulatory requirements when developing SOPs for histology and cytology testing.

Purpose and Scope :

The purpose of histology and cytology testing SOPs (Standard Operating Procedures) is to provide a set of guidelines and instructions for laboratory personnel to follow when processing, staining, and interpreting histological and cytological specimens. These SOPs are designed to ensure that accurate and consistent results are obtained, and that potential errors are minimized.

The scope of histology and cytology testing SOPs typically includes all personnel involved in the process, from specimen collection to final interpretation. This includes laboratory technicians, pathologists, cytologists, and other relevant staff. The SOPs may cover all aspects of the process, including equipment, reagents, safety, and quality control measures. The ultimate goal is to ensure that all laboratory personnel are following the same procedures, using the same techniques and equipment, and obtaining consistent and reliable results.

Sample Collection SOPs:

SOPs should specify the appropriate collection methods and storage conditions for samples to ensure that they remain viable for testing.

Sample collection is an essential step in the histology testing process, as the quality of the tissue sample obtained can significantly impact the accuracy of the final diagnosis. Here are some general steps that could be included in the SOPs for sample collection for histology testing:

1. Patient preparation: The SOP should specify any preparation required from the patient before the sample is collected. For example, fasting or medication restrictions.
2. Sample site identification: The SOP should outline the appropriate procedures for identifying the specific site of the tissue sample, including the use of imaging techniques, such as ultrasound or CT scans.
3. Collection techniques: The SOP should detail the appropriate technique for collecting the tissue sample, such as biopsy or excision, and any specific considerations for the type of tissue being collected.
4. Handling and storage: The SOP should provide guidelines for handling and transporting the tissue sample to the laboratory, including the use of appropriate containers, labels, and storage conditions, such as temperature and humidity.
5. Quality control: The SOP should include procedures for ensuring the quality and integrity of the tissue sample, including the use of appropriate controls and validation methods.
6. Documentation and reporting: The SOP should specify the appropriate methods for documenting the collection process, including the use of patient and specimen identifiers, and the information required for accurate reporting.

It’s crucial to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for sample collection for histology testing, as the specific procedures and protocols may vary depending on the type of tissue being collected and the equipment and resources available in the laboratory.

Sample Preparation SOPs:

SOPs should provide detailed instructions on how to prepare the samples for testing, including fixation, embedding, and sectioning procedures.

Sample preparation is a critical step in the histology testing process, as it ensures that the tissue sample is properly preserved and prepared for examination under the microscope. Here are some general steps that could be included in the SOPs for sample preparation for histology testing:

1. Sample fixation: The SOP should specify the appropriate method for fixing the tissue sample to preserve its cellular structure, including the use of appropriate fixatives, such as formalin or alcohol.
2. Tissue processing: The SOP should detail the appropriate protocols for processing the tissue sample, including embedding, sectioning, and staining techniques. This may include the use of automated tissue processors and staining instruments.
3. Microscopic examination: The SOP should outline the steps for examining the tissue sample under the microscope, including the use of appropriate magnification, illumination, and focus settings.
4. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the sample preparation, including the use of appropriate controls and validation methods.
5. Documentation and reporting: The SOP should specify the appropriate methods for documenting the sample preparation process, including the use of patient and specimen identifiers, and the information required for accurate reporting.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for sample preparation for histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Equipment and Materials:

SOPs should include a list of equipment and materials required for histology and cytology testing, including the specifications for each item.

Equipment and materials are crucial components of histology testing, as they ensure the accuracy and consistency of the results. Here are some general steps that could be included in the SOPs for equipment and materials for histology testing:

1. Equipment maintenance and calibration: The SOP should specify the appropriate procedures for maintaining and calibrating the equipment used in histology testing, such as microtomes, tissue processors, and staining instruments.
2. Reagent preparation: The SOP should provide guidelines for preparing the reagents used in histology testing, including the use of appropriate safety protocols and quality control measures.
3. Reagent storage and handling: The SOP should outline the appropriate procedures for storing and handling the reagents, including the use of appropriate containers, labels, and storage conditions.
4. Equipment and material inventory: The SOP should specify the appropriate methods for tracking the inventory of equipment and materials used in histology testing, including the use of inventory records and regular audits.
5. Equipment and material disposal: The SOP should include procedures for disposing of any equipment or materials that are no longer in use, including the use of appropriate waste disposal methods.
6. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the equipment and materials used in histology testing, including the use of appropriate controls and validation methods.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for equipment and materials for histology testing, as the specific procedures and protocols may vary depending on the equipment and resources available in the laboratory.

Sample Processing:

In this step, the specimens are processed through a series of steps to create thin, stained slides for examination under the microscope.

Sample processing is a crucial step in histology testing that involves the preparation of tissue samples for examination under a microscope. Here are some general steps that could be included in the SOPs for sample processing in histology testing:

1. Sample fixation: The SOP should specify the appropriate method for fixing the tissue sample to preserve its cellular structure, including the use of appropriate fixatives, such as formalin or alcohol.
2. Tissue processing: The SOP should detail the appropriate protocols for processing the tissue sample, including embedding, sectioning, and staining techniques. This may include the use of automated tissue processors and staining instruments.
3. Microscopic examination: The SOP should outline the steps for examining the tissue sample under the microscope, including the use of appropriate magnification, illumination, and focus settings.
4. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the sample processing, including the use of appropriate controls and validation methods.
5. Documentation and reporting: The SOP should specify the appropriate methods for documenting the sample processing process, including the use of patient and specimen identifiers, and the information required for accurate reporting.
6. Troubleshooting and problem-solving: The SOP should outline the steps for addressing any issues or problems that may arise during the sample processing process, including the use of appropriate problem-solving techniques and the escalation of issues when necessary.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for sample processing in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Staining protocols:

SOPs should specify the type of stains to be used, the staining procedures, and the interpretation of results.

Staining is a critical step in histology testing that involves the use of dyes or chemicals to enhance the visualization of tissue structures under a microscope. Here are some general steps that could be included in the SOPs for staining protocols in histology testing:

1. Selection of appropriate stains: The SOP should specify the appropriate stains to use for different tissue types, as well as the protocols for preparing the staining solutions.
2. Deparaffinization and hydration: The SOP should detail the appropriate protocols for removing paraffin from the tissue sample and rehydrating it with a series of alcohol solutions.
3. Staining: The SOP should specify the appropriate staining protocols, including the duration of the staining, the use of appropriate controls, and the steps for rinsing and dehydrating the sample after staining.
4. Counterstaining: The SOP should outline the appropriate protocols for counterstaining, which involves the use of a second stain to highlight specific tissue structures.
5. Microscopic examination: The SOP should detail the steps for examining the stained tissue sample under the microscope, including the use of appropriate magnification, illumination, and focus settings.
6. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the staining protocols, including the use of appropriate controls and validation methods.
7. Documentation and reporting: The SOP should specify the appropriate methods for documenting the staining protocols, including the use of patient and specimen identifiers, and the information required for accurate reporting.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective staining protocols for histology testing, as the specific staining procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Microscopic examination:

Specify the criteria for examining samples under a microscope, such as magnification levels, identification of cells or structures, and interpretation of results.

Microscopic examination is a critical step in histology testing that involves the examination of tissue samples under a microscope. Here are some general steps that could be included in the SOPs for microscopic examination in histology testing:

1. Calibration and maintenance of microscopes: The SOP should specify the appropriate procedures for maintaining and calibrating the microscopes used in microscopic examination to ensure the accuracy and consistency of the results.
2. Tissue sample preparation: The SOP should detail the appropriate protocols for preparing tissue samples for microscopic examination, including the use of appropriate fixatives, embedding, sectioning, and staining techniques.
3. Microscopic examination: The SOP should outline the appropriate protocols for examining the tissue sample under the microscope, including the use of appropriate magnification, illumination, and focus settings.
4. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the microscopic examination, including the use of appropriate controls and validation methods.
5. Documentation and reporting: The SOP should specify the appropriate methods for documenting the microscopic examination process, including the use of patient and specimen identifiers, and the information required for accurate reporting.
6. Troubleshooting and problem-solving: The SOP should outline the steps for addressing any issues or problems that may arise during the microscopic examination process, including the use of appropriate problem-solving techniques and the escalation of issues when necessary.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for microscopic examination in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Revision and review:

SOPs should be regularly reviewed and revised to ensure that they remain current and effective.

The revision and review of histology testing SOPs is an essential part of maintaining quality and ensuring the accuracy and consistency of test results. Here are some general steps that could be included in the SOPs for the revision and review process:

1. Schedule regular reviews: The SOP should specify the frequency of reviews and revisions, which may depend on regulatory requirements, accreditation standards, or changes in laboratory practices.
2. Establish review committees: The SOP should outline the composition of review committees, including the appropriate personnel responsible for reviewing and revising the SOPs.
3. Determine areas for revision: The review committee should evaluate the effectiveness of the SOPs, identify any areas that require revision or improvement, and document these findings.
4. Develop revision plan: The SOP should detail the steps for developing a revision plan, including the timelines, responsible parties, and communication channels for implementing changes.
5. Communicate changes: The SOP should specify the appropriate methods for communicating changes to the SOPs to relevant personnel, including training requirements for any new or revised procedures.
6. Document revision history: The SOP should include procedures for documenting the revision history of the SOPs, including the dates of revisions, the changes made, and the personnel responsible for the revisions.
7. Quality control: The SOP should include procedures for ensuring the quality and accuracy of the revised SOPs, including the use of appropriate controls and validation methods.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for the revision and review process in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Quality control:

SOPs should include measures to ensure quality control, such as the use of positive and negative controls, regular calibration of equipment, and regular review of results by trained professionals.

Quality control is a critical aspect of histology testing to ensure accurate and reliable results. Here are some general steps that could be included in the SOPs for quality control in histology testing:

1. Establish quality control procedures: The SOP should specify the appropriate quality control procedures for each step of the histology testing process, including sample collection, preparation, processing, staining, and microscopic examination.
2. Use appropriate controls: The SOP should detail the use of appropriate controls, including positive and negative controls, to validate the accuracy and precision of the testing process.
3. Monitor instrument performance: The SOP should specify the appropriate procedures for monitoring the performance of instruments and equipment used in the testing process, including calibration, maintenance, and troubleshooting.
4. Evaluate test results: The SOP should outline the appropriate procedures for evaluating test results, including the use of appropriate statistical methods, and documenting any deviations or discrepancies from expected results.
5. Document quality control measures: The SOP should include procedures for documenting all quality control measures taken during the testing process, including the results of any quality control tests or evaluations.
6. Implement corrective actions: The SOP should specify the appropriate procedures for implementing corrective actions when quality control measures indicate deviations or discrepancies from expected results, including the communication of any corrective actions to relevant personnel.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for quality control in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Reporting and documentation:

Determine how results will be reported and documented, including data entry, report formatting, and archiving of results and samples.

The reporting and documentation of histology testing results are critical components of ensuring the accuracy and reliability of test results. Here are some general steps that could be included in the SOPs for reporting and documentation in histology testing:

1. Define reporting requirements: The SOP should specify the appropriate reporting requirements for each type of histology test performed, including the format and content of the test report.
2. Ensure accuracy of reports: The SOP should outline procedures for ensuring the accuracy of test reports, including the verification of patient identification, test results, and any other relevant information.
3. Document test results: The SOP should specify the appropriate procedures for documenting test results, including the use of electronic or paper-based systems for data entry and storage.
4. Maintain patient confidentiality: The SOP should detail procedures for maintaining patient confidentiality and privacy, including the appropriate handling and disposal of patient information.
5. Follow regulatory requirements: The SOP should ensure that all reporting and documentation procedures comply with relevant regulatory requirements and accreditation standards.
6. Review and verify reports: The SOP should specify procedures for reviewing and verifying test reports before finalization, including the appropriate personnel responsible for this process.
7. Retain records: The SOP should outline procedures for retaining records of test reports and related documentation, including the appropriate retention periods and methods for storage and retrieval.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for reporting and documentation in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Data management:

SOPs should include procedures for data management, including data entry, storage, and retrieval, as well as procedures for archiving and disposing of samples.

Effective data management is crucial for ensuring the accuracy and reliability of histology testing results. Here are some general steps that could be included in the SOPs for data management in histology testing:

1. Define data management requirements: The SOP should specify the appropriate data management requirements for each type of histology test performed, including the format and content of the data.
2. Document data sources: The SOP should outline procedures for documenting the sources of data, including patient information, test results, and any other relevant information.
3. Ensure data accuracy: The SOP should detail procedures for ensuring the accuracy of data, including data entry verification and validation.
4. Ensure data security: The SOP should outline procedures for ensuring the security and confidentiality of data, including appropriate data storage and access control measures.
5. Implement backup and recovery procedures: The SOP should specify procedures for implementing data backup and recovery procedures in case of data loss or corruption.
6. Follow regulatory requirements: The SOP should ensure that all data management procedures comply with relevant regulatory requirements and accreditation standards.
7. Review and verify data: The SOP should specify procedures for reviewing and verifying data before finalization, including the appropriate personnel responsible for this process.
8. Retain records: The SOP should outline procedures for retaining records of data and related documentation, including the appropriate retention periods and methods for storage and retrieval.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for data management in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Safety protocols:

SOPs should include safety protocols, such as the use of personal protective equipment (PPE), disposal of hazardous materials, and proper handling of sharps.

Safety protocols are critical to protecting the health and well-being of laboratory personnel and ensuring the accuracy and reliability of histology testing results. Here are some general steps that could be included in the SOPs for safety protocols in histology testing:

1. Define safety requirements: The SOP should specify the appropriate safety requirements for each type of histology test performed, including personal protective equipment (PPE) and other safety measures.
2. Ensure proper use of PPE: The SOP should detail procedures for ensuring the proper use of PPE, including gloves, lab coats, goggles, and respirators.
3. Minimize exposure to hazardous materials: The SOP should outline procedures for minimizing exposure to hazardous materials, including the appropriate handling and disposal of chemical and biological wastes.
4. Ensure proper use of equipment: The SOP should specify procedures for ensuring the proper use of equipment, including microtomes, tissue processors, and staining machines.
5. Follow regulatory requirements: The SOP should ensure that all safety protocols comply with relevant regulatory requirements and accreditation standards.
6. Develop emergency response procedures: The SOP should detail procedures for responding to emergencies, including fire, chemical spills, and exposure incidents.
7. Provide regular safety training: The SOP should specify procedures for providing regular safety training to laboratory personnel, including hazard communication, PPE use, and emergency response.
8. Review and update safety protocols: The SOP should specify procedures for reviewing and updating safety protocols regularly, based on changes in laboratory operations, equipment, or regulatory requirements.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for safety protocols in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Equipment maintenance:

SOPs should include procedures for regular maintenance and calibration of equipment used in testing.

Equipment maintenance is critical to ensuring the accuracy and reliability of histology testing results and maximizing the lifespan of laboratory equipment. Here are some general steps that could be included in the SOPs for equipment maintenance in histology testing:

1. Define maintenance requirements: The SOP should specify the appropriate maintenance requirements for each type of histology equipment used in the laboratory, including microtomes, tissue processors, and staining machines.
2. Develop a maintenance schedule: The SOP should outline procedures for developing a maintenance schedule, including the frequency of inspections, cleaning, and calibration.
3. Ensure proper use of equipment: The SOP should specify procedures for ensuring the proper use of equipment, including following the manufacturer’s instructions and using the appropriate accessories and supplies.
4. Train personnel on maintenance procedures: The SOP should detail procedures for training laboratory personnel on equipment maintenance procedures, including inspection, cleaning, and calibration.
5. Develop troubleshooting procedures: The SOP should outline procedures for identifying and troubleshooting equipment malfunctions, including procedures for replacing parts and repairing equipment.
6. Document maintenance activities: The SOP should specify procedures for documenting all maintenance activities, including the date and time of maintenance, the personnel responsible, and the equipment condition before and after maintenance.
7. Follow regulatory requirements: The SOP should ensure that all equipment maintenance procedures comply with relevant regulatory requirements and accreditation standards.
8. Review and update maintenance procedures: The SOP should specify procedures for reviewing and updating maintenance procedures regularly, based on changes in laboratory operations, equipment, or regulatory requirements.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for equipment maintenance in histology testing, as the specific procedures and protocols may vary depending on the type of equipment being used and the resources available in the laboratory.

Training and competency:

SOPs should include requirements for training and competency assessments for staff involved in the testing process.

Training and competency assessment are crucial to ensuring that laboratory personnel are properly trained to perform histology testing procedures accurately and reliably. Here are some general steps that could be included in the SOPs for training and competency in histology testing:

1. Define competency requirements: The SOP should specify the appropriate competency requirements for each type of histology testing procedure performed, including technical skills, knowledge, and judgment.
2. Develop a training program: The SOP should outline procedures for developing a comprehensive training program, including orientation training for new employees and ongoing training for existing employees.
3. Identify trainers and assessors: The SOP should detail procedures for identifying qualified trainers and assessors, including experienced laboratory personnel and certified trainers.
4. Conduct training sessions: The SOP should specify procedures for conducting training sessions, including hands-on training, classroom training, and e-learning.
5. Assess competency: The SOP should outline procedures for assessing competency, including practical assessments, written tests, and observation of work.
6. Document training and competency assessment: The SOP should specify procedures for documenting all training and competency assessment activities, including the date and time of training and assessment, the personnel involved, and the competency level achieved.
7. Review and update training and competency procedures: The SOP should specify procedures for reviewing and updating training and competency procedures regularly, based on changes in laboratory operations, equipment, or regulatory requirements.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for training and competency assessment in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested and the equipment and resources available in the laboratory.

Record keeping:

SOPs should specify the requirements for record keeping, including the types of records that need to be kept and the retention period.

Record keeping is an important aspect of histology testing, as it provides a record of the testing process, results, and quality control measures. Here are some general steps that could be included in the SOPs for record keeping in histology testing:

1. Define record keeping requirements: The SOP should specify the appropriate record keeping requirements for each type of histology testing procedure performed, including sample preparation, staining, and microscopic examination.
2. Develop record keeping procedures: The SOP should outline procedures for developing a comprehensive record keeping system, including forms, logs, and databases.
3. Document all activities: The SOP should specify procedures for documenting all activities related to histology testing, including sample collection, preparation, and examination, as well as quality control measures and any deviations or incidents.
4. Ensure accuracy and completeness: The SOP should detail procedures for ensuring the accuracy and completeness of all records, including data entry, verification, and correction.
5. Store records securely: The SOP should specify procedures for storing records securely, including protection against loss, damage, or unauthorized access.
6. Retain records for the required duration: The SOP should outline procedures for retaining records for the required duration, based on regulatory and accreditation requirements.
7. Review and update record keeping procedures: The SOP should specify procedures for reviewing and updating record keeping procedures regularly, based on changes in laboratory operations, equipment, or regulatory requirements.

It’s essential to consult with qualified laboratory professionals and regulatory guidelines to develop appropriate and effective SOPs for record keeping in histology testing, as the specific procedures and protocols may vary depending on the type of tissue being tested, the equipment and resources available in the laboratory, and the applicable regulatory requirements.

References:

1. American Society for Clinical Pathology. (2020). Histotechnologist and Histotechnician Certification Exam Content Guidelines. https://www.ascp.org/content/docs/default-source/boc-pdfs/histotech-content-guidelines.pdf?sfvrsn=e3ce5213_2
2. College of American Pathologists. (2021). Anatomic Pathology Laboratory Accreditation Program Checklist. https://documents.cap.org/documents/2021-LAP-Checklist.pdf
3. National Society for Histotechnology. (2019). Standard Operating Procedures. https://www.nsh.org/sites/default/files/guideline-documents/2019/NSH_SOPs_2019.pdf
4. Occupational Safety and Health Administration. (2021). Laboratory Standard. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450
5. United States Pharmacopeia. (2021). General Chapter <1035> Biotechnology – Quality Management System. https://www.usp.org/sites/default/files/usp/document/harmonization/gen-chapter-1035-biotechnology-quality-management-system.pdf

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