Inspections, Compliance, Enforcement, and Criminal Investigations
Sample Schedule 10: DRUG SAMPLING SCHEDULES (DOES NOT INCLUDE ANTIBIOTIC PREPARATIONS)
STERILITY TESTING VITAMINS, DEVICES, & DRUGS
|Type of Product||Sample Size1|
|INV Sample2||Official [702(b) & Check]3|
1 Double sample size requirements when individual containers are 2 ml (2 g) or smaller.
2 INV sample includes units (30 for Drugs & 40 for devices) for examination and 6 units for bacteriostasis.
3 Official Sample includes units (30 for drugs & 40 for devices) for examination, units (30-40) for check, 20 units for 702(b) [21 U.S.C. 372(b)] and 6 for bacteriostasis.
Note: If a lot is aseptically filled into 200 finished units or less, sample no less than 10% of lot.
DISSOLUTION TEST - USP & NF
Unless directed otherwise by your assignment or supervisor, submit samples to your normal servicing laboratory.
Collect a 200 tablet portion for drug potency analysis by the collecting district lab, plus a separate 100 tab portion to be split for dissolution testing.
MICROBIOLOGICAL EXAMINATION OF DRUGS (Other than for Sterility)
|PRODUCT||MINIMUM SAMPLE SIZE
(Includes 702(b) portion)
|Sub Size||Nos. of Subdivisions|
|Dosage Form Drugs (See #1 below), Bulk
Drugs, or Raw Materials for Manufacturing
|90 g or 90 ml||10|
- Contact the laboratory (which has microbiological testing capabilities) serving your district for sample size requirements before sampling dosage form drugs containing less than 3 grains, 200 mg, or 25% of the suspect ingredient.
- Use aseptic technique when collecting samples from raw materials or bulk containers. Implements and sample containers used must be sterile. Submit controls. See IOM 4.3.6 through 18.104.22.168.
- Submit samples to the laboratory with microbiological testing capabilities which serves your district unless directed otherwise.