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FDA Warning Letter: Sampling Plans and Strategies

Recently, FDA emphasized on lack of scientifically sound and appropriate sampling plans for inspection by releasing a warning letter. The warning letter underlines the lack of Company’s scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the Company lacks appropriate statistical sampling plans for the inspection of paper label rolls.

FDA, by releasing this warning reminds the regulatory need to sample a number of units (finished drug product, in-process materials, APIs, raw material, excipients, packaging components and labels) that is based on statistical criteria. Indeed, 21 CFR 211.84(b) requires that the number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria. The criteria for sampling involves component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by CFR 211.170.

Regulatory agencies have Statistically-based sampling plans available (e.g. ISO 2859-1 or ANSI/ASQC Z1.4 for series of lots; e.g. ISO 2859-2 or ANSI/ASQC-Q3 for isolated lots) and which can be used for sampling the above mentioned reserve samples or rolls leaflets. Materials can be classified in three general categories

1. Unitary material (it consists of essentially identical units e.g., finished product, leaflets, test tubes, vials, stoppers, medical devices etc)

2. Particulate material (Powders of API, Excipient, granulate, blend etc)

3. Bulky-continuous material (water, liquid solution, viscous solutions, gel, cream, compressed gas, steam etc) The first category of material is easily amenable to statistical sampling by attributes.  Sampling of the other two categories is often based on a risk-based approach aimed at multi-point sampling and testing to capture any intra-batch variability. At either category, the ultimate aim the sampling plan is to test/inspect a scientifically-sound selected representative sample.


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