By Food and Drug Administration
Compact Regs elements 210 and 211. content material: booklet disguise; name; Copyright; half 210-CURRENT reliable production perform IN production, PROCESSING, PACKING, OR keeping of gear; basic; half 211--CURRENT reliable production perform FOR accomplished prescription drugs; key-phrase INDEX TO 21 CFR components 210 AND 211. summary: Compact Regs elements 210 and 211
Read or Download Compact Regs Parts 210 and 211 : Cfr 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical Gmps (10 Pack) PDF
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Extra resources for Compact Regs Parts 210 and 211 : Cfr 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical Gmps (10 Pack)
D) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel. (e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed. (f) Use of gang-printed labeling for different drug products, or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color.
192. The 58 results of the examination shall be recorded and maintained with other stability data on the drug product. Reserve samples of compressed medical gases need not be retained. The retention time is as follows: (1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the drug product. (2) For a radioactive drug product, except for nonradioactive reagent kits, the reserve sample shall be retained for: (i) Three months after the expiration date of the drug product if the expiration dating period of the drug product is 30 days or less; or (ii) Six months after the expiration date of the drug product if the expiration dating period of the drug product is more than 30 days.
184 Component, drug product container, closure, and labeling records. 80; and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known. 122(a)) and the conclusions derived therefrom. (c) An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure.