Which part outlines the requirements for labeling and good manufacturing practices?

The correct answer pertains to the regulation that outlines requirements for labeling and good manufacturing practices (GMP) relevant to both food and drug products. This regulatory framework is primarily covered in Title 21 of the Code of Federal Regulations, specifically under Part 211, which provides details on current good manufacturing practices for pharmaceuticals, ensuring that products are produced consistently and controlled according to quality standards. Additionally, it involves labeling requirements as outlined in other sections like those pertaining to the Federal Food, Drug, and Cosmetic Act.

The other options, while they reference parts of the CFR, do not specifically focus on the same breadth of labeling and GMP requirements. For instance, parts 600 deal with biologics, which have some labeling requirements but do not comprehensively address the GMP aspect for all products. Similarly, parts 100 and 200 contain information on food labeling and regulations, but these sections do not cover the detailed GMP requirements required for manufacturing processes and quality assurance that is seen in part 211. Part 814, on the other hand, is focused on premarket approval, which is related to device submissions rather than labeling and GMP in a broader sense. Thus, the best choice reflects the comprehensive requirements surrounding both labeling and manufacturing practices.