Current Good Manufacturing Practices (cGMP) finalized by US FDA

Dec. 8, 2015 - PRLog -- Finalized US FDA Rules Apply to Food Operations

The United States Food and Drug Administration (US FDA) published the final rules for the Current Good Manufacturing Practices (cGMPs) and Preventive Control for Human (1) and Animal (2) foods. These are the first two of the seven major Food Safety Modernization Act (FSMA) rules to be finalized.

Human Food: Preventive Controls and cGMPs

Every facility must have a written food safety plan that includes a hazard analysis, preventive controls, a supply-chain program, recall plan, procedures for monitoring, corrective action procedures and verification procedures. Hazard analyses must consider known or reasonably foreseeable biological, chemical (including radiological) and physical hazards, whether natural, unintentionally introduced or intentionally introduced for economic gain. Preventive controls are process, food allergen, sanitation and supply chain controls with a recall plan. Verification will include the validation of preventive controls, the verification of monitoring and corrective action, the calibration of verification monitoring and equipment, as well as product testing and environmental monitoring for items required, such as ready to eat foods, and record reviews. The food safety plan is to be revisited every three years, or more frequently if necessary. The supply chain program involves use of approved suppliers by the receiver, determining appropriate supplier verification procedures based on the hazards, then conducting and documenting the verification. This verification can be an onsite audit, sampling and testing, or a review of the relevant food safety records. The verification activity, and its frequency, will be based on the hazard and on supplier performance.

Facilities storing unexposed food are exempt from preventive control requirements, except if time/temperature control monitoring is a requirement; in this case, corrective actions and verification of the temperature controls must be performed. Very small businesses, defined as operations with less than $1 million USD in sales of human food that manufacture, process, pack or hold food without sale, have modified preventive control requirements.

These very small businesses are to attest either that they meet these qualifications; or, if not, which hazards have been identified and the preventive controls implemented and monitored; or that the facility is in compliance with non-federal food safety law.

Compliance dates:

- Very small businesses and businesses subjected to the pasteurized milk ordinance – September 17, 2018
- Small business (Less than 500 full time equivalent employees) – September 17, 2017
- All other businesses – September 17, 2016

Supply-Chain program compliance will be six months after the applicable rule involving the supplier.
cGMPs for allergen cross-contamination and voluntary cGMPs, such as training and education, are now required.

Animal Food: Preventive Controls and cGMPs

There are now cGMPs for animal food operations, covering personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and the holding and distribution of human food by-products for use as animal foods. These are less strict in nature than the human food requirements and many are designated as “if necessary”. Requirement for training is a cGMP for animal food.

The preventive control requirements are the same as the human food program.

Compliance dates for the preventive control part of the rule:

- Very small businesses – September 17, 2019
- Small business (Less than500 full time equivalent employees) – September 17, 2018
- All other businesses September 17, 2017

Compliance dates for the cGMP part of the rule (same as in prior section):

Supply chain program compliance will be six months after the applicable rule involving the supplier.

References:

(1) Office of the Federal Register – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Foods – 17 September 2015 (https://www.federalregister.gov/articles/2015/09/17/2015-...)

(2) Office of the Federal Register – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Foods – 17 September 2015 (https://www.federalregister.gov/articles/2015/09/17/2015-...)

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