Pathogen Listeria Monitoring Services
1.1.
To provide services in
developing, implementing, and monitoring your establishments requirements for protecting
Company’s products against Listeria contamination in accordance to 21 CFR 117.130 Hazard Analysis (b)(1) (i), 21
CFR 117.135 Preventive Controls (c)(1)(i)(ii), and 21 CFR 117.165 Verification
of Implementation and Effectiveness (a)(2).
1.2.
The purpose of this service is
to provide the programs, policies, procedures (SOPs), forms for records, and training
materials for Listeria control to be implemented and monitored by employed personnel.
1.3. To comply with cGMP requirements of Part 117 with respect to measures that can significantly minimize or prevent the contamination of food with L. monocytogenes whenever food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
2.1.
L. monocytogenes is an environmental
pathogen that can contaminate foods and cause a mild, non-invasive illness
(called listerial gastroenteritis) or a severe, invasive illness (called
listeriosis).
2.2. Foods that have caused outbreaks are typically contaminated from the environment during manufacturing/processing or packing.
3.1.
Environmental Monitoring Program
3.1.1. Verification of the
effectiveness of environmental control programs for L. monocytogenes;
3.1.2. Monitoring of corrective actions has eliminated L. monocytogenes and harborage sites when found in the plant.
3.1.3. Monitoring of sample collection and testing from Food Contact
Surfaces and Non-Food Contact Surfaces
3.1.4. Drafting and Implementing Corrective Actions
3.1.5. Strategies for Environmental Monitoring
3.1.6. Vector Swabbing Protocols and
Implementation.
3.1.7. Listericidal Treatment monitoring
3.1.8. Food Formulation Controls
3.1.9. Handling Controls
3.1.10. Shelf-Life Controls
3.1.11. Storage Controls
3.2.
Sampling Areas
3.2.1. Zone 1 Controls - Food-Contact Surfaces
3.2.2. Zone 2 Controls – Non-food-contact surfaces in close proximity to
food and food contact surfaces.
3.2.3. Zone 3 Controls - More remote non-food-contact surfaces that are in
or near the processing areas and could lead to contamination of zones 1 and 2
3.2.4. Zone 4 Controls - Non-food-contact surfaces, remote areas outside of the processing area, from which environmental pathogens can be introduced into the processing environment
3.3.
Written Procedures for
Environmental Monitoring
3.3.1. Scientifically valid
3.3.2. Testing for Listeria spp. or L.
monocytogenes;
3.3.2.1.
Location Identification
3.3.2.2.
Timing and Frequency of
Sampling and Testing
3.3.2.3.
Testing Methodology
3.3.2.4.
Laboratory Identification
3.3.2.5. Corrective Action (intensified cleaning and sanitation, sampling, testing, root cause analysis, and implementing “hold and test” procedures).
3.4.
Preventive Controls per 21 Part
117 requirements development, implementation and monitoring;
3.4.1. Sec. 117.126 – Food safety
plan
3.4.2. Sec. 117.130 – Hazard
analysis
3.4.3. Sec. 117.135 – Preventive
controls
3.4.4. Sec. 117.139 – Recall plan
3.4.5. Sec. 117.140 – Preventive control
management components
3.4.6. Sec. 117.145 – Monitoring
3.4.7. Sec. 117.160 – Validation
3.4.8. Sec. 117.165 – Verification
of implementation and effectiveness
3.4.9. Sec. 117.170 – Reanalysis
3.4.10. Sec 117.190 – Implementation records required for this subpart.
4.
Responsibility
4.1.
Sanitation Personnel
4.2.
Warehouse and Storage Personnel
4.3.
PCQI / QC / Qualified Personnel
4.4.
QC Department Personnel
4.5.
Compliance Personnel
4.6.
Senior Management
5.
Documents (References)
5.1.
Assessment Checklist
5.2.
Forms Time / Temperature Logs
5.3.
Sampling Procedures
5.4.
Environmental Monitoring Log
and Forms
5.5.
Cold Storage Logs
5.6.
Lab Submission Forms and Log
5.7. Delivery Vehicle Inspection Procedures
References
- Title 21-Food and Drugs,
Chapter I - Food and Drug Administration, Department of Health and Human
Services, Subchapter B - Food for Human Consumption, Part 117 – Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls
for Human Food.
- Sec. 117.9 Records required
for this subpart
- Control of Listeria
monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance, U.S. Department of Health and
Human Services Food and Drug Administration Center for Food Safety and Applied
Nutrition January 2017