Monthly Validation Checklist ( Shige)

• Client / Site

• Location
  Address

• Conducted on

  Date

• Prepared by

1.1 Design and Construction

• There is adequate space provided for orderly placement of equipment and materials to prevent mix-ups and contamination.

  ✔

  ✖

  N/A

• Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity, lighting, etc...).

  ✔

  ✖

  N/A

• All food contact surfaces are made of materials appropriate to the application (i.e. stainless steel vs. aluminum).

  ✔

  ✖

  N/A

• Floors, walls, ceilings, doors and windows are completely sealed to prevent entry of pests.

  ✔

  ✖

  N/A

• Loading dock doors are flush to the floor when closed.

  ✔

  ✖

  N/A

• There is separation of defined areas and adequate controls to prevent contamination.

  ✔

  ✖

  N/A

1.2 Construction and Maintenance

• Were there any temporary equipment repairs?

  Yes

  No

  N/A

• Weighing, measuring, monitoring, and testing equipment critical for ensuring quality should be calibrated according to written procedures, established schedules and using certified or traceable standards.

  ✔

  ✖

  N/A

1.3 Pest control program

• A documented pest control program is in place.

  ✔

  ✖

  N/A

• Building exterior is protected from rodent and pest entry.

  ✔

  ✖

  N/A

• Map with locations of all traps identified

  ✔

  ✖

  N/A

• The pest control program includes monthly inspections.

  ✔

  ✖

  N/A

• The supplier maintains and enforces written procedures for the application of pesticides.

  ✔

  ✖

  N/A

• The facility audits pest control operator performance.

  ✔

  ✖

  N/A

1.4 Cleaning & Sanitation

• Utensils used for cleaning food contact surfaces are controlled and clearly identified.

  ✔

  ✖

  N/A

• Measures are in place to verify and monitor the effectiveness of cleaning methods. (Weekly/Monthly/Annual Cleaning Schedule)

  ✔

  ✖

  N/A

• Cleaning and sanitization procedures are validated and well-documented as such.

  ✔

  ✖

  N/A

• Cleaning and usage logs established for equipment to include: dates, products, lots#, person who used, person who cleaned.

  ✔

  ✖

  N/A

• A chemical control program manages the use, storage, and handling of non-food chemicals at the manufacturing facility.

  ✔

  ✖

  N/A

• Are the reviving forms filled out properly?

  Yes

  No

  N/A

• Are the COI's present in the receiving packet? (Monthly random check)

  Yes

  No

  N/A

• Are all chemical control closets secured and access restricted?

  Yes

  No

  N/A

• Are all chemical labeled?

  Yes

  No

  N/A

• Does the chemical inventory log match the actual inventory?

  Yes

  No

  N/A

• Are all the chemicals in use on the approved chemical list?

  Yes

  No

  N/A

• Is the MSDS book updated?

  Yes

  No

  N/A

2.3 Storage

• Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.

• Temperature and humidity is acceptable

  ✔

  ✖

  N/A

• Storage bins are not cracked or chipping

  Select ✔ ✖ N/A

  • ✔
  • ✖
  • N/A

• Quality Assurance section segregated from usable products and labeled with a "HOLD" sticker

  ✔

  ✖

  N/A

• Warehouse area is clean and orderly - products are not stored on floor and 6 inches off ground

  ✔

  ✖

  N/A

• Are all glass and plastics in a defined area or position?

  Yes

  No

  N/A

• Is there any breakage in the production or processing area of glass or brittle plastics?

  Yes

  No

  N/A

• Is there any allergens in the Production/Processing Areas?

  Yes

  No

  N/A

• Are all doors (entrance, receiving and emergency exit) secured?

  Yes

  No

  N/A

• Are surveillance cameras on? (Check for blue light)

  Yes

  No

  N/A

• Is visitor log book by entrance and is it signed and updated?

  Yes

  No

  N/A

• Is there anyone in the facility other than staff that is not on the visitor log book?

  Yes

  No

  N/A

7.2 Hygienic Practices

• Are there hygienic practices in place to protect against contamination of food?

  ✔

  ✖

  N/A

• Is personnel wearing clean clothing suitable for the processing activity. Additional protective apparel, such as hairnet, face mask, gloves when in clean rooms.

  ✔

  ✖

  N/A

• Any person, by medical examination or supervisory observation, that is shown to have, or appears to have, an illness, or open lesions, by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials being contaminated, shall be excluded from any operations until condition is corrected.

  ✔

  ✖

  N/A

• Personnel shall be instructed to report such conditions to supervisors.

  ✔

  ✖

  N/A

• Designated areas outside of processing zones have been provided for clothing and other personal belongings (Jackets, cell phones, bags, radios, CD players, headsets, pagers).

  ✔

  ✖

  N/A

• Consumption of food & beverages, chewing of gum, or the use of tobacco products are strictly prohibited in processing areas.

  ✔

  ✖

  N/A

• Proper hand washing practices are reinforced with signs posted in breakrooms, production areas, and washrooms.

  ✔

  ✖

  N/A

7.3 Training Procedures

• GMP Topic

• Employee Name

• Question 1

• Answer

• Question 2

• Answer

• Question 3

• Answer

• Yes

  No

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A

Completion

• Recommendation

• Full Name and Signature

  Sign