GMP Requirement: All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of: physical factors such as: time, temperature, humidity, water activity (Aw), pH, pressure, flow rate, and manufacturing operations such as: freezing, dehydration, heat processing, acidification, and refrigera-tion to ensure that mechanical breakdowns, time delays, temperature fluctuarefrigera-tions, and other factors do not contribute to decompo-sition or contamination of food.
GMP Requirement: Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or control-ling Aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health signifi-cance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.
What You Can Do
To comply with the two GMP requirements that require food processors to control physical factors in manufacturing operations that prevent the growth or destroy harmful microorganisms you need to:
Determine the physical factors that affect the growth of microorganisms of concern in your products.
Develop procedures to control physical factors that destroy, prevent, or minimize the potential for the growth of pathogenic mi-croorganisms. These procedures must make sure that target levels for temperature, time, pH, or Aw are consistently reached in the manufacturing process.
Establish a validated process with a food safety expert that describes the conditions, such as minimum or maximum time and temperature limits, water activity, pH, or salt levels, necessary for your situation.
Monitor the steps in the process that are necessary to reach target levels for one or more of the physical factors identified in the validated process.
How To Monitor
Supervisors or other trained individuals should be assigned responsibility for routine monitoring of the food and ingredients that are received, stored and processed. Each processing step must also be monitored to ensure that the basic conditions determined in a vali-dated study have been achieved to minimize the potential for the growth of microorganisms. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If any corrections are necessary to fix problems, those actions should also be noted on an appropriate written record.
GMP Requirement: Food that can support the growth of undesirable microorganisms, particularly those of public health sig-nificance shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compli-ance with this requirement may be accomplished by any effective means, including:
1. Maintaining refrigerated foods at 45°F (7°C), or 2. Maintaining frozen foods in a frozen state, or 3. Maintaining hot foods at 140°F (60°C)* or above, or
4. Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
What You Can Do
To meet the GMP requirement for the proper storage of foods that can support the growth of harmful microorganisms you need to:
Determine what storage conditions must be maintained for each of the foods that you receive, store, or process.
Obtain the equipment such as refrigeration, freezing, or hot storage units that is needed for proper storage. Adequate refrigera-tion or freezer units should be able to maintain the temperature of these foods below 41°F (5°C) or keep them solidly frozen. If hot foods are held or stored, equipment must be available to keep them above 140°F (60°C), or 135°F (57°C) if required by local or state regulations.
Develop an adequate process in consultation with a food safety expert for acidified foods that are stored in sealed containers at room temperature. The food must be heated using a pre-determined process to kill mesophilic microorganisms before it is hermeti-cally sealed in its container.
Monitor storage conditions routinely.
Monitor process conditions when producing acidified foods in sealed containers.
How To Monitor
The temperature of refrigeration and freezer units should be routinely checked throughout the day. Procedures used to hold hot foods or heat foods should be monitored routinely or for each batch as necessary to demonstrate that the proper time and temperature limits have been met. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observa-tions for your own use. If correcobserva-tions are needed to fix problems, those acobserva-tions should also be noted on a written record.
GMP Requirement: Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at the temperature for the required time, and then rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality.
What You Can Do
To meet the GMP requirement for blanching you need to:
Develop a procedure that specifies the minimum temperature and time for blanching and how all food products will be rapidly chilled after blanching to prevent the growth of harmful bacteria or other microorganisms.
Maintain, clean, and sanitize blanching equipment.
Use water that is safe and sanitary (potable).
Monitor the blanching process to determine that the proper temperature was reached, held for the proper amount of time, and then cooled to the target temperature within the required amount of time.
How To Monitor
The temperature and time of the blanching and cooling process should be routinely checked throughout the day or as necessary. Cleaning and sanitizing procedures for blanching equipment should also be monitored and checked as necessary. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. Monitoring observa-tions for the cleaning and sanitizing equipment should be included in the appropriate sanitation record. If correcobserva-tions are needed to fix problems, those actions should be noted on an appropriate written record.
GMP Requirement: Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or main-tained in such a manner that they are protected against contamination. Compliance with this requirement may be accom-plished by any effective means, including one or more of the following:
1. using ingredients free of contamination;
2. employing adequate heat processes where applicable;
3. using adequate time and temperature controls;
4. providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them;
5. cooling to an adequate temperature during manufacturing;
6. disposing of batters at appropriate intervals to protect against the growth of microorganisms.
What You Can Do
If you use or produce batters, breading, sauces, gravies, or dressing, to comply with this GMP requirement you need to:
Develop and implement controls to prevent these foods from being contaminated and to prevent the growth of harmful bacteria like Staph during processing and storage. Time and temperature controls should minimize the amount of time that these foods are exposed to temperatures above 50°F (10°C).
Establish a validated process based on a scientific study by a food safety expert, if heat is used to kill harmful bacteria like Staph.
The process controls developed by the study should comply with USDA guidance for meat and poultry products or FDA guidance for seafood products.
Discard any product that is exposed to unacceptable conditions.
Monitor all manufacturing or storage steps for these foods to make sure that time and temperature control limits established in the validation study are met.
How To Monitor
Production employees should be trained to monitor the process to make sure that time and temperature limits are not exceeded or that target levels identified in your validated process are reached. Supervisors should routinely check these monitoring results to make sure that the proper conditions have been met before product is released into the marketplace. Supervisors should also monitor conditions to make sure that workers or the plant environment do not contaminate these foods. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If corrections are needed to correct problems, those actions should also be noted on an appropriate written record.
GMP Requirement: Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and
dehydrated food, that relies on the control of water activity (Aw) for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this
requirement may be accomplished by any effective means, including employment of one or more of the following practices:
1. Monitoring the Aw of the food;
2. Controlling the soluble solids to water ratio in the finished food;
3. Protecting finished food from moisture pickup by use of a moisture barrier or by other means so that the Aw of the food does not increase to an unsafe level.
What You Can Do
If you use or produce dry, dehydrated or semi-moist foods that depend on the control of water activity to maintain safety, to comply with this GMP requirement you need to:
Evaluate dry foods when they are received to determine that they are packaged correctly and/or have been produced and shipped in a way that has not allowed them to absorb enough moisture to enable harmful bacteria or other microorganisms to grow.
Store acceptable food and ingredients in packages, or containers that will prevent them from absorbing moisture during storage.
Package finished food products as necessary to maintain the proper water activity.
Establish a validated process if you manufacture or produce dry, dehydrated or semi-moist foods that rely on a low water activity to prevent the growth of bacteria or other microorganisms that could cause foodborne illness. This can be done by having a valida-tion study done by a food safety expert.
Monitor the processing variables for each batch to determine that they have reached the target levels identified in your validated process. These variables may include conditions such as air temperature, air flow, humidity, and time. Alternatively, processors could control the soluble solids to water ratio in the finished product.
How To Monitor
Production employees should be trained to monitor the steps in your process that are necessary to make sure all products meet the target levels identified in your validation study. This could include monitoring the conditions established in your validated process for each batch of product that is produced or monitor periodically in a continuous operation. Supervisors should routinely check these monitoring results to make sure that critical conditions have been met before product is released into the marketplace. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If corrections are needed to fix problems or products need to be re-processed, these actions should also be noted on the appropriate written record.
GMP Requirement: Food such as, but not limited to, acid and acidified foods, that relies principally on the control of pH for pre-venting the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
1. monitoring the pH of raw materials, food in process, and finished food;
2. controlling the amount of acid or acidified food added to low-acid food.
What You Can Do
To comply with the GMP requirements for acid or acidified foods you need to:
Determine which foods or ingredients, if any, that you receive, store or process depend on the control of acidity or pH to ensure safety.
Establish a validated process if you manufacture or produce acidified, pickled, or fermented foods that rely on a pH of 4.6 or below to prevent the growth of bacteria or other microorganisms that could cause foodborne illness. A validation study must be conducted by a food safety expert to determine the processing variables necessary to reach the target pH. These variables include the type, amount and concentration of the acid ingredient to be added to a pre-determined amount of product of the appropriate thickness or size, and the amount of time and temperature needed to reach a pH of 4.6 or below in the finished product.
Monitor each of the variables identified in the validation study for each batch. Alternatively, the pH of each batch of food produced could be directly measured using a standard procedure.
How To Monitor
Production employees should be trained to monitor the process to ensure that they meet target levels identified in your validation study for each batch or periodically as necessary in a continuous operation. Supervisors should routinely check these monitoring results to make sure that critical conditions have been met before product is released into the marketplace. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If corrections are needed to fix problems or products need to be re-processed, those actions should also be noted on an appropriate record.