Manufacturers - 1
The GMP regulations can be characterized by four primary functions:
- Process Design: where critical factors, including the thermal process, are identified and established properly;
- Process Delivery: which addresses the suitability of the equipment and facilities to deliver the process;
- Process Documentation: which addresses monitoring and documentation through the keeping of records to allow anyone to determine at any time, for any day's production, whether an adequate process was delivered to every container.
- Container Integrity: which addresses the container closure and post-processing handling aspects, to ensure that contamination after processing does not occur.
Using the regulations as a guide, an investigator can determine a firm's compliance on days when not present at the firm by obtaining documentation of process design (a processing authority's written recommendation), confirming the firm's ability to deliver the process (by observing equipment, operations, and facility layout) and that the processes were delivered as required on any given day of production (through review of previous production records required by the GMP), and that can seam integrity is being controlled (through record review and observation of equipment and cans).
When the proposed regulations Parts 128b (now 113) and 90 (now 108), were being discussed, it was recognized that there were certain critical elements (i.e. critical control points) inherent in basically every LACF process, which if not controlled could cause or contribute to a health hazard.
It is a firm's responsibility to identify, and control critical control points through the use of certain procedures; and to document that such procedures were performed. Under this concept, FDA's responsibility is to monitor management's adherence to the above principles.
The Part 108 regulations are the regulatory link from the GMP regulation (Parts 113 and 114) to Section 404 of the Act. They contain certain mandatory conditions and requirements including the requirement for compliance with 21 CFR 113 and 114 [see sections 108.25(a) and 108.35(a)].
Regulatory action taken under Part 108 is an administrative action, i.e., we take the action without going through the courts. The decision to take emergency permit action is a final agency decision, but it can be appealed through the courts.
Part 108 is divided into two Subparts, A and B. Subpart A entitled 'General Provisions' contains definitions and the enforcement mechanisms for the applications of Section 404; Subpart B, entitled 'Specific Requirements and Conditions for Exemption From or Compliance with an Emergency Permit', contains the specific mandatory conditions and requirements for acidified foods (108.25) and low-acid canned food (108.35).
Following is a discussion of each section of Subpart A and the mechanics of taking various actions under Part 108, following the normal occurrence of events, not the numerical order of each section:
§108.5 - Determination of the need for a permit.
The order of determination of need for a permit is issued to the firm, by a letter signed by the Center Director, when an inspection reveals that a processor is not in compliance with the mandatory conditions and requirements of Subpart B (including Parts 113 and 114). The order specifies the mandatory conditions and requirements with which there is a lack of compliance (this is why it is important that a thorough inspection be conducted to identify all requirements which are not in compliance). The order states that the processor cannot distribute LACF or acidified food in interstate commerce until the firm is in compliance with all the mandatory conditions and requirements of Part 108.25 and/or 108.35, and 113 and/or 114, and until the firm receives a permit or advance written approval from FDA in accordance with §108.12.
The processor is afforded a hearing if he files objections to the order on the issues, e.g., the investigator reports an observation and the processor disagrees with that observation. The hearing is held within 5 days and follows the procedures in 21 CFR 16, unless the Agency decides that the objections raise no genuine and substantial issue of fact. Objection based on the processor's discontent with our decision is not a substantial issue of fact. The order is stayed pending a hearing, or a decision that a hearing is not justified. The processor can present witnesses and cross-examine FDA personnel.
§108.12 - Manufacturing, processing or packing without a permit or in violation of a permit.
Once a processor receives the order that he