Good Manufacturing Practices

Per the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) regulations, application of good manufacturing practices (GMPs) are integral to production of safe foods. This section outlines recommendations on management of personnel, tools and equipment, floor traffic and housekeeping procedures to limit the inadvertent transfer and spread of Listeria monocytogenes (Lm) in the facility.

View Program

Good Manufacturing Practices

Per the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) regulations, application of good manufacturing practices (GMPs) are integral to production of safe foods. This section outlines recommendations on management of personnel, tools and equipment, floor traffic and housekeeping procedures to limit the inadvertent transfer and spread of Listeria monocytogenes (Lm) in the facility.

View Program

GOOD MANUFACTURING PRACTICES RECOMMENDATIONS

Controlled Use of Water
  • High pressure water should not be used during production to avoid aerosoling and potentially cross-contaminating the production environment.

RESOURCES:

has been added to your library!

have been added to your library!

Facility Environment and Temperature
  • Temperature control in critical storage areas is maintained and temperature recording devices or indicators are appropriately located and and accesible.
  • Temperature control chart or other temperature collection methods are available.
  • Manual checking and recording are used as a cross-reference to automatic controls at agreed frequency with immediate corrective action in case of non-conformance.
  • Minimum annual calibration frequency.

RESOURCES:

has been added to your library!

have been added to your library!

Food Safety Culture for Lm Control
  • A culture of proper housekeeping and organization should be developed and these behaviors must be consistently applied.
  • Routine monitoring throughout the facility and plant grounds, followed by necessary corrective actions are critical.

RESOURCES:

has been added to your library!

have been added to your library!

GMP Auditing
  • Internal audits are in place and performed at a regular frequency.
  • Corrective actions are implemented & documented.
  • Learnings are shared and effectively communicated across the company with all relevant personnel.

RESOURCES:

has been added to your library!

have been added to your library!

GMP Inspections
  • Internal GMP inspections identify minor and potentially significant issues or opportunities that may lead to timely and permanent corrective actions.
  • Audits focus on thorough review and documentation.
  • Root cause analysis is comprehensive and targets prevention of recurring issues.

RESOURCES:

has been added to your library!

have been added to your library!

Inspection of Delivery Vehicles
  • A vehicle inspection program is established.
  • Prior to loading and unloading, all delivery vehicles are inspected to ensure they are clean and free from moisture.
  • Internal inspection reports are easily accesible.
  • Non-conformances and corrective action records are easily accesible.

RESOURCES:

has been added to your library!

have been added to your library!

Loading and Unloading of Delivery Vehicles
  • Vehicles used for distribution of chilled or frozen foods are loaded using sealed docks.
  • Trailers, containers and rail cars maintain specified temperatures.
  • Temperatures are recorded during transit and meet specifications.

RESOURCES:

has been added to your library!

have been added to your library!

Maintenance Activities in the Facility
  • Maintenance inspections and work order systems are synchronized between the QA and operations teams.
  • A mechanism for audits and feedback should be established to ensure building and equipment are adequately maintained so that they do not become harborage points for potential contamination.

RESOURCES:

has been added to your library!

have been added to your library!

Maintenance Personnel and Tools
  • Maintenance personnel comply with facility GMP programs, including PPE and doning requirements.
  • Tools are cleaned and sanitized routinely; preferably dedicated to post lethality/high hygiene areas.

RESOURCES:

has been added to your library!

have been added to your library!

Material Traceablity within the Facility
  • Product, ingredients and work-in-process should be designated to zone-labeled and/or coded containers.
  • Containers should be restricted to specified areas in accordance with plant policies
  • Traceability should be maintained for ingredients, work in progress and product through delivery to the customer.

 

 

Movement of Personnel in the Facility
  • A dedicated transition area should be used to don appropriate clothing/gear and to wash hands prior to entering production areas.
  • Signage is present to alert employees of areas with thier respective “care” designations.

RESOURCES:

has been added to your library!

have been added to your library!

Personal Protective Equipment
  • Color coding of protective workwear (clothing and footwear) in high hygiene or post-lethality areas is important to delineate higher risk and greater concerns of cross contamination.
  • It is highly recommended that employees working in post-lethality/high hygiene areas wear additional protective clothing as they enter these areas.

RESOURCES:

has been added to your library!

have been added to your library!

Personnel Behaviors
  • Employees, contractors, and visitors know facility GMPs and do not create a risk to product quality and safety.
  • Workforce is empowered and exhibits excellent food safety behaviors.

RESOURCES:

has been added to your library!

have been added to your library!

Personnel Clothing and Footwear
  • Company-approved clothing and footwear are used and they are clean and well maintained.
  • A company-approved program for a captive clothing and footwear program is highly recommended.

RESOURCES:

has been added to your library!

have been added to your library!

Personnel Training
  • Employees are trained annually on GMPs and receive frequent reinforcement.
  • Employees know and follow the training materials.
  • Contractors receive relevant training.
  • Training records are maintained and training tools are continuously improved and reinforced to increase awareness.
  • Training expectations are communicated and validated through observations and performance feedback.

RESOURCES:

has been added to your library!

have been added to your library!

Storage of Materials in the Facility
  • All materials are stored off the floor on clean pallets at least 18 inches away from the wall to facilitate cleaning and pest control activities and to allow product ventilation.

RESOURCES:

has been added to your library!

have been added to your library!

Waste Management
  • Waste should be handled so as not to contaminate the production environment or product.
  • Waste should be separated, staged and stored in readily identifiable containers which are routinely emptied, cleaned and sanitized.
  • Waste should be appropriately classified (trash, recycle, by-product for animal feed) regularly.
  • Any spillage should be removed and cleaned immediately.
  • Waste receptacles including dumpsters, compactors, balers, etc., should be cleaned routinely.