Drug products that have been subjected to improper storage conditions (including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation) due, for example, to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Such exposure can pose a serious risk to a drug’s identity, strength, quality, purity or safety (see 21 CFR Part 211.208, Drug Product Salvaging). This fundamental CGMP principle applies to any component, in-process material, or finished drug product subjected to such conditions.
In some cases, there may be substantial and reasonable uncertainty whether a drug was subjected to these conditions. In such a circumstance, it is essential that a firm nonetheless err on the side of caution in its risk assessment to assure an appropriate lot disposition decision and conduct a rigorous evaluation in accord with the standards described under 21 CFR Part 211.208.
When there is reasonable uncertainty whether a drug was subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory testing that the drugs meet all applicable standards of identity, strength, quality, and purity, and from inspection that the drugs and their associated packaging were not subject to improper storage conditions as a result of the disaster or accident.
When determining whether drugs have been subjected to such improper conditions, a firm’s actions should include but not be limited to:
Obtaining supply chain information, including knowing the names and addresses of all suppliers and distributors of a drug (including components and packaging) to determine if there is a reasonable possibility that such materials were stored under improper conditions.
Determining details such as the timeframe, duration, nature, scope, and location of exposure as well as identity of all lots potentially subjected to the improper conditions (e.g., ramifications of a natural disaster such as power disruptions should be considered to assure a complete risk assessment).
Obtaining certification (either on the certificate of analysis or as a separate statement) declaring that drug lots, including components and packaging, were not subjected to improper storage conditions.
