Source: http://pharmapathway.com/cgmp-21-code-of-federal-regulations-parts-210-and-211-article-1/
Timestamp: 2019-03-19 02:37:17
Document Index: 374902104

Matched Legal Cases: ['arts 210', 'arts 210', 'arts 210', 'art 210', 'art 225', 'art 226', 'art 211']

CGMP: 21 Code of Federal Regulations Parts 210 and 211- Article (1) | Pharma Pathway
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CGMP: 21 Code of Federal Regulations Parts 210 and 211- Article (1)
Part 210 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).
Non-fiber-releasing filter means any filter, which after any appropriate pre-treatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.
Inactive ingredient means any component other than an “active ingredient.”
The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of Part 225 of this chapter.
The term medicated premix means a Type A medicated article as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of Part 226 of this chapter.
Strength means: (I) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or (ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).
Part 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.
211.86 Use of approved components, drug product containers, and closures. 211.87 Retesting of approved components, drug product containers and closures.
Asst. Manager at NetZealous LLc, Bengaluru
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