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FDA Pre-Licensure Checklist

FDA, or Food and Drug Administration, is an agency within the US Department of Health and Human Services. It is responsible for ensuring people's good health by providing them with safe food, drugs, vaccines, cosmetics, and dietary supplements. FDA also regulates tobacco products, helps speed up product advancement and it is a source of good-quality, scientific information that people can use to improve and maintain good health. It also provides checklist for assessing quality and safety of products before they are released into the market. The checklist embraces many aspects of the product manufacturing such as the the facilities where the product is produced, equipment used for the production, personnel, raw materials and the very process of production.

  1. Building and Facilities

    • Building and the facilities where a given product is manufactured has to be checked for a suitable size, design, orderly storage and cleanliness. All surfaces; floors, walls and ceiling should be smooth and facilitate easy cleaning. Fixtures, ducts and pipes have to be in a good condition so that no fluids drip out of them and contaminate the materials or working surface. Lighting should be sufficient so that workers are comfortable. Also, water supply, washing and toilet facilities should be ample to ensure the cleanliness of the facilities and the personnel.

    Equipment

    • Equipment should be checked for appropriate size, design and quality. It should be well-maintained, clean and sanitized regularly. It should be stored in a safe and clean storage to protect it from dirt, dust and contamination with sanitizing agent or other lubricants.

    Personnel

    • Personnel needs to have appropriate education, training and experience to perform their job properly. They need to wear protective clothes, gloves, hair bands, and boots. They need to maintain personal cleanliness and restrict food, drink and tobacco consumption to specially dedicated places.

    Raw Materials

    • Raw materials and primary packaging are stored and handled in such a way that contamination with dirt and bacteria, and loss of freshness due to exposure to heat, cold, sunlight and moisture is avoided. Containers are supposed to be stored and labelled appropriately. Materials must be tested for lack of filth, bacteria and other contaminants. If the tests show traces of any unwanted agent, the materials are removed from production.

    Production

    • Making sure that the production is performed according to written specifications is the longest process on the checklist. The production has to take place in a safe and clean environment. The equipment used for production as well as tools and utensils have to be in good working condition, clean and used according to the prescribed use. Only approved raw materials are used for production and regular tests must be performed during and after the production to make sure that it is proceeding according to the rules.

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