Reserve Samples_21CFR211.170

Reserve samples are maintained for API as well as drug products. The recommended amount of the reserve samples is at least twice the amount required for one time testing of the API or the Drug Product (Except for Pyrogen & Sterility testing). 

The retention time of reserve samples in different scenarios for APIs is as given below:

1.  For an API used in a drug product the retention time is expiry of the last batch or lot of the drug product produced with it + 1 year

e.g. if an API is used in a drug product with expiry of two years with mfg. dates Jan. 2015, Feb. 2015 & finally April 2015. The respective expiry of the drug products will be Dec. 2016, Jan. 2017 and March 2017. Thus, we are required to retain the API till March 2018 i.e. expiry of the last batch produced of the drug product + 1 year.

2.  For an API of a radio-pharmaceutical with expiry less than 30 days, the retention period of the API is expiry of the last batch of the drug product produced with it + 3 months

3.  For an API of a radio-pharmaceutical with expiry more than 30 days, the retention period of the API is expiry of the last batch of the drug product produced with it + 6 months

4. For an API of an OTC drug product which is exempted from the expiry date requirements as mentioned in the 21 CFR 211.137, the retention period is 3 year from the date after the last batch/lot of the OTC drug product is distributed into the market.

The retention time of reserve samples in different scenarios for Drug Products is as given below:

1.  For  a drug product the retention time is expiry + 1 year

2. For a  radio-pharmaceutical drug product with expiry less than 30 days, the retention period of the drug product is expiry + 3 months

3.  For a  radio-pharmaceutical drug product with expiry more than 30 days, the retention period of the drug product is expiry + 6 months

4. For an OTC drug product which is exempted from the expiry date requirements as mentioned in the 21 CFR 211.137, the retention period is 3 year from the date after the batch/lot of the OTC drug product is distributed into the market.

NOTE: The reserve samples shall be visually evaluated at least once a year for deterioration (provided there is no harm to its integrity). Any deterioration in the reserve samples observed shall be investigated as per 21CFR211.192.