Inspections, Compliance, Enforcement, and Criminal Investigations

Sample Schedule 10: DRUG SAMPLING SCHEDULES

(Does not include Antibiotic Preparations)

STERILITY TESTING VITAMINS, DEVICES, & DRUGS

Type of ProductSample Size1
 INV Sample2Official [702(b) & Check]3
DRUGS3686
DEVICES46106

LEGEND:

1Double sample size requirements when individual containers are 2 ml (2 g) or smaller.
2INV sample includes units (30 for Drugs & 40 for devices) for examination and 6 units for bacteriostasis.
3Official 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.

SAMPLE SIZE

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)

PRODUCTMINIMUM SAMPLE SIZE
(Includes 702(b) portion)
 Sub SizeNos. of Subdivisions
Dosage Form Drugs (See #1 below), Bulk
Drugs, or Raw Materials for Manufacturing
90 g or 90 ml10

SAMPLING INSTRUCTIONS

  1. 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.
  2. 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 4.3.6.5.
  3. Submit samples to the laboratory with microbiological testing capabilities which serves your district unless directed otherwise.

 

Page Last Updated: 07/28/2015
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