| | | | | - Hand sanitizing stations in the manufacturing area |
| | | | | - Rubbish and offal disposal |
| Part 1 considered the inspection process. We now | | | | |
| turn to the specifics of what FDA investigators | | | | |
| generally focus on during a plant inspection. | | | | 110.40 Equipment and utensils |
| | | | | |
| Because there are no record keeping requirement | | | | - Condition before processing begins |
| in the umbrella CGMPs (21 CFR 110), investigators | | | | - Cleaning of filtering systems |
| must rely entirely on can be observed directly or | | | | - Sanitary condition of equipment |
| deduced from samples collected during an | | | | - Prior history and cleaning procedures for leased |
| inspection, unless they demand records under the | | | | equipment |
| Bioterrorism Act of 2002 ( In the case of acidified | | | | - Residue on conveyor belts |
| and low-acid foods, they can supplement and | | | | - Cleaning, sanitizing, and storage of cleaning |
| support their observations from an examination | | | | implements |
| of the required records. In all cases, however, | | | | - Effectiveness of cleaning practices |
| investigators are well trained to look, listen, and | | | | - Placement of mercury thermometers and light |
| draw conclusions from what they see and hear. | | | | bulbs |
| The following lists those things for which | | | | - Monitoring and replacement of UV lights |
| investigators typically "look and listen". For more | | | | - Nature, frequency, supervision, and |
| information, the reader is referred to the FDA | | | | effectiveness of sanitizing practices |
| Investigations Operations Manual, Subchapter 5.4 ( | | | | |
| The issues that follow are keyed to the relevant | | | | |
| sections of the umbrella CGMPs. | | | | 110.80(a) Raw materials |
| | | | | |
| 110.10 Personnel | | | | - Storage – pattern, rotation, housekeeping, |
| | | | | accessibility for inspection, evidence of infestation |
| - Identity of owners, partners or officers, and | | | | - Handling procedures |
| management officials/employees involved in the | | | | - Inspection practices |
| inspection | | | | - Use of “Food Chemicals Codex” to |
| - Attitude and actions of employees discharging | | | | assure the use of only food-grade materials |
| their duties | | | | |
| - Employee dress and cleanliness | | | | |
| - Health of food-contact employees | | | | 110.80(b) Manufacturing processes |
| - Unsanitary employee practices | | | | |
| - What employees tell the inspector | | | | - Whether and how hands and equipment are |
| - Employee education and training | | | | sanitized after contact with unsanitized surfaces |
| | | | | - Methods for re-using scrap materials – e.g. |
| | | | | soaking or hand kneading – to protect from |
| 110.20 Plant and grounds | | | | microbial contamination |
| | | | | - Ingredient handling -- contamination with filth; |
| - Environmental factors that may contribute to | | | | effectiveness of cleaning and inspection operations |
| rodent, bird, insect, or other sanitation problems | | | | prior to or while adding to the process; lags during |
| - Design and condition of buildings | | | | the process |
| - Toilet facilities | | | | - Food additives -- legal; restricted to legal |
| - Company attitude toward maintenance | | | | amount; packaging materials and waxes or |
| - Waste and garbage disposal | | | | chemicals applied to fresh fruit excluded during |
| - Methods for preventing waste materials from | | | | routine inspections |
| being mingled with raw materials | | | | - Color additives |
| - Disposition of waste containing pesticide residues | | | | - Quality control -- inspection system; laboratory |
| - Removal of moisture (condensate) and oil from | | | | tests both on site and contracted; manufacturing |
| central compressed air supply | | | | code system |
| - Undrained loops in central compressed air supply | | | | |
| - Standing water | | | | |
| | | | | 110.93 Warehousing and distribution |
| | | | | |
| 110.35 and .37 Sanitary operations, facilities, and | | | | - How well the food is protected during storage |
| controls | | | | and transportation |
| | | | | |
| - Condition and appearance of the plant | | | | |
| - Cleaning and sanitizing materials and their storage | | | | Daily meetings with the investigator provide an |
| - Pest control program and effectiveness | | | | opportunity to learn early in the inspection if the |
| - Cleaning sanitizing of food contact surfaces | | | | investigator has observed any CGMP deviations. |
| - Adequacy of the water supply and plumbing | | | | Any deviations that can be corrected before the |
| - Floor drainage | | | | inspection is finished should be and the correction |
| - Sewage disposal | | | | shown to the investigator (more about this in Part |
| - Hand-washing and toilet facilities | | | | 3. |