211∙ 46Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate
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Plant and facilities: The building has enough space to install equipment and place materials in an organized manner to avoid mixing different types of ingredients, drug containers, seals, labels, intermediates or drugs with each other, and the material flow is designed
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Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee‘s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action
Batchmeans a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
211∙ 84(e) any lot number of ingredients, drug containers or seals, if they meet the specified homogeneity, potency or content, quality, purity, and other specification standards and the relevant tests in this part (d), before approval for use, and shall be rejected if they do not meet these requirements.
211 ∙ 105 equipment identification (a) throughout the production cycle, the same batch of drug production using all the ingredients and storage containers, production lines and major equipment should be correctly identified, marked with the contents of the container, if necessary, should identify the production process
211∙ 111 Production Time Limits: Time limits for the completion of each production phase should be established when appropriate to ensure the quality of the drug product. Deviations from the established time limits are acceptable if they do not compromise the quality of the drug product. These deviations shall be justified and justified by written ation.