Working with standard operating procedures (SOPs) - Quality Assurance - page 88

components, drug product containers, closures, packaging,
labeling materials, or regulated products. 4 Consider another
regulated area. Regarding the manufacture of human tissue
products, the CFR states that any facility used in the
manufacture of human cells, tissues, and cellular and tissue-
based products (HCT/Ps) must be maintained in a clean,
sanitary, and orderly manner, to prevent the introduction,
transmission, or spread of communicable disease. 5
The FDA has requirements for cleaning and sanitizing for
a number of regulated processes that are listed in Table 4.1. 6
Any surface or area that might adversely impact the safety,
identity, strength, purity, and quality (SISPQ) of the regulated
product must be cleaned and sanitized. This includes the
various surfaces of buildings and facilities, equipment and
utensils, and containers and closures. With respect to facilities,
rooms and zones of buildings are typically classifi ed in terms of
levels of particulate matter allowable in the air or on surfaces.
Moreover, there are three major categories of soils and other
impurities that must be removed from a surface. These are:

1. product from a previous manufacturing run;
2. bioburden, such as various microorganisms; and
3. the cleaning and sanitizing agents from previous cleaning
activities.

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Table 4.1 FDA requirements for cleaning and sanitizing

Regulated process 21 CFR Section CFR Heading

Food § 110.20 Plant and grounds

Food § 111.15 Sanitation requirements

Drugs § 211.56 Sanitation

Biologicals § 600.11 Physical establishment

Blood § 606.40 Facilities

Human Tissues § 1271.190 Facilities