Similar to most companies in today's economy, FDA is under resourced and is need of marketing and good press. While sterile drugs and devices pose more of a potential health risk to individuals and are clearly focus industries for the agency, it is food processing issues and noncompliant food firms that make the headlines. Therefore, as of recent, the agency has shifted its focus to food processors and distributors that have been identified as "problematic", have never been audited, or have not been audited in many years. With the relatively low margins in food operations (as compared to drug and medical device products), food processors, packagers, and distributors need to be prepared for their next FDA audit in order to lower the risk of numerous inspectional observations resulting in:
FDA gets "put under the gun" by the American public when people get sick from the food supply. While there are numerous ways in which food can make us sick, the most common is from microbial contamination. Therefore, due to FDA's limited resources, the agency typically inspects for ways in which the food product processed and stored by a company could become contaminated from a microbiological perspective. The following are four (4) areas in which organizations involved in processing and storing foods should focus on to prevent microbial contamination and FDA scrutiny.
Facilities and Equipment
In the FDA's eyes, it is paramount that the facility and equipment be designed (e.g. 21 CFR 110.20) and maintained in such a fashion to prevent microbial contamination.
For food processing and storage facilities, this means that work surfaces, product contact equipment surfaces, AND other potential areas where food may be exposed to contamination (e.g. ceiling tiles) must be designed and constructed of materials that are not prone to moisture absorption, are cleanable, and are maintained. There should be no exposure to the outside environment except via maintained doorways. This means no roof leaks, holes in screens, or an accumulation of dust on fan blades that are blowing onto packaging lines. With current interpretation of 21 CFR 110.37, this includes employee bathroom maintenance (e.g. hot water available at each faucet, clean vents, etc.).
While new packaging equipment is typically supplied with preventive maintenance procedures, it is critical to develop a standard operating procedure (SOP) on facility and equipment maintenance in-house that includes, but is not limited to, procedural steps, forms for documenting maintenance activities, approved spare parts lists, and a master schedule of periodic maintenance. While numerous software applications exists, manual maintenance programs are acceptable for food facilities as long as activities are actually performed, documented, and verifiable.
It is also critical to perform a hazard analysis to identify potential areas where objectionable organisms such as Salmonella can grow and survive (i.e. niche areas). Like most activities in FDA regulated facilities, niche areas should be "corrected", but some level of "preventive action" should be taken and documented as well to meet current FDA expectations.
Cleaning
Equipment and facility cleaning requirements (e.g. 21 CFR 110.80) are often coupled with the requirements for adequate design and maintenance. SOPs for cleaning equipment, including, but not limited to, utensils, need to be developed for each piece of equipment/utensil and for the facility itself (inside and out). Similar to the procedures for maintenance, cleaning procedures need to be documented and include the cleaning instructions, intervals, and forms for verifying that the cleaning work has in fact been performed as scheduled. In addition, temperatures, cleaning agents, and hold times need to be defined, as applicable to the cleaning processes.
Pest Control Remember, in accordance with 21 CFR 110.120, FDA does not have to find evidence of pest contamination to document noncompliance with pest control regulations. Companies must show adequate preventive measures as well. Obviously, documentation must exist that show pest control has been completed at periodic intervals. However, several other items are key in developing a food processor or packager is in compliance with current regulatory expectations. For example, the pest control procedure must specify that only approved vendors (if outside contractors are used by the facility) are to be used for pest control. Also, the types of pesticides, and rodenticides that are allowed to be in the processing, packaging, and storage areas must be specified. It is highly recommended that vendors be escorted when applying pesticides to ensure raw materials and finished product do not inadvertently come into contact with the pesticides. While pest control is imperative for cleanliness, lack of adequate pest control can contribute to microbial and other significant contamination issues.
Training and Internal Audits On Performance Like with all relationships, first impressions are key when hosting a FDA inspection. Facilities that appear to be clean and in order yet that have "holes" in documentation are often cited less and benefit from shorter current good manufacturing practices (cGMP) inspections than those with unorganized and dirty appearances (yet relatively decent documentation).
Employees of food processing and distribution facilities should be persuaded to inform management when the equipment or facility appears dirty of not maintained. Employees should be trained to ensure "line clearance" immediately after a production run and prior to subsequent production runs to ensure product and components from previous lots have been removed. Use of adequate signage (e.g. hand washing after using the bathroom) may seem obvious, but these relatively minor preventive tasks help reinforce training and help show FDA auditors that cleanliness and prevention of microbial contamination is in the minds of management and employees at the facility.
In addition to training, periodic audits should be employed to ensure that the facility and equipment is being cleaned and maintained and in accordance with the preapproved procedures. While this may take place in-house, often companies turn to
outside regulatory compliance services to execute these internal audits. Not to worry though, a company does not have to show results of these internal audit to FDA inspectors. However, it is recommended that the approved form for what is to be looked for as well as documentation that the internal audits have been done (i.e. a log) be provided to FDA to demonstrate awareness and concern for quality and compliance.
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