Expiration Dating Of Pharmaceuticals

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21 CFR § 211 .137 - Expiration dating . | CFR | US Law | LII . . .
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Bulk Drug Substances (Bulk Pharmaceutical Chemicals) While expiration dating is not required specifically for bulk drugs in the CGMP regulations, it is feasible and valuable to expect the . . .
www .pharmacy180 .com › article › expiry-date-of-pharmaceuticals-892
EXPIRY DATE OF PHARMACEUTICALS It is a legal requirement that all pharmaceutical products must carry the date of manufacture and date of expiry on their label . The period between the two dates is called the 'life period' or 'shelf-life' of the drug .
November 26, 2019: This posting and FDA's November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of . . .
§ 211 .137 Expiration dating . (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211 .166 .
Maximum Expiration Dating for drug products shall not exceed five (5) years . Extension of Expiration Dating for already manufactured and packaged drug product may be performed based on the following criteria: Continuous, controlled real-time stability program has shown the product to be stable to support the extended expiration dating ;
A tentative expiry dating period of upto 24 months will be assigned to all solid dosage forms, if the drug has retained 90% of its original potency after 90 days storage at 40°C ± 2°C/75% ± 5%RH . The same shall be confirmed by long term stability studies . The expiry date of a drug product should not exceed the expiry date of the drug substance .
Common practice in the industry is to use within 30 days of the retest date . Under current rule, a new date for retesting beyond 30 days of immediate use should be based on current retest results and supporting stability data . Successive retest periods may not be longer than the original retest period assigned by the manufacturer of the API .
Expiry of first API is Dec 2019 . The expiry of second API is Nov 2019 . Then the finished product shall be assigned expiry date as Nov 2019 . When more than one AR No . of API (s) is used, then the assigned expiry date to the finished product shall be of the API with AR No . bearing shortest shelf life .
Expiry of first API is Nov 2019 . The expiry of second API is Oct 2019 . Then the finished product shall be assigned expiry date as Oct 2019 . When more than one AR No . of API (s) is used, then the assigned expiry date to the finished product shall be of the API with AR No . bearing shortest shelf life .
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Expiration Dating Of Pharmaceuticals

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