European Regulation

  •  Council Directive 92/25/EEC of 31 March 1992 PDF on the wholesale distribution of Medical products for human use
  •  Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) PDF in accordance with Article 10 of Council Directive 92/25/EEC PDF .

U.S Regulation

Code of Federal Regulations (Title 21, Volume 4, Revised as of April 1, 2014, Cite: 21CFR211.94):

(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
(c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated.
(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

Standards, Practices and Articles

  • AFNOR NF S99-700 October 2007  (Isothermal and refrigerating containers for health products – Thermal performance qualification method).
  • ISTA 5B υπερσύνδεση με το Focused simulation guide of thermal performance – Testing of temperature controlled transport packaging.
  • ISTA 7D υπερσύνδεση με το  Development tests to evaluate the effects of external temperatures exposures of individual packaged-products.
  • Word Health Organization (Guidelines on the international packaging and shipping of vaccines)
  • What is cold chain?

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