Sampling Plan for Pharmaceuticals

Q: We are a U.S. dietary supplements manufacturer operating under c-GMP conditions set by the U.S. Food & Drug Administration (FDA).

As such, we perform analyses of incoming raw materials (finished product ingredients), intermediate products (during manufacturing), and finished products. Analyses include identity testing (incoming raw materials), and other types of analysis (e.g. microbiological, heavy metals, some quantitative assays on specific compounds). These tests would be the attributes we wish to assess. 

Basically, we are refining our sampling procedures and need to ascertain an acceptable number of samples to be taken for the various testing purposes outlined above.

The World Health Organization’s (WHO) Technical Report Series No. 929,  Annex 4, “WHO Guidelines for sampling of pharmaceutical products and related materials” references ANSI/ISO/ASQ 2859-1:1999 Sampling procedures for inspection of attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection in reference to the selection of a statistically-valid number of samples for testing purposes. 

I note from your website that there are a number of other sampling standards available. I am seeking some guidance as to the most appropriate standard(s) for our particular purposes. 
 
Any assistance you can offer would be much appreciated.

A: Though many of the sampling plans are similar, many standards organizations have published different interpretations of sampling schemes.  Since WHO recommends using ISO 2859-1 as the guidance document, I suggest selecting that plan.  

There are similar documents that could be used as an alternative, if necessary:

1. ANSI/ASQ Z1.4-2008: Sampling Procedures and tables for inspection by attributes

2. BS 6001-1:1999/ISO 2859-1:1999+A1:2011 Sampling procedures for inspection by attributes. Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

3. MIL-STD-105E – Sampling Procedures and Tables for Inspection by Attributes*

4. JIS Z9015-0-1999 Sampling procedures for inspection by attributes — Part 0 Introduction to the JIS Z 9015 attribute sampling system

A few points to consider:

  • Usually for FDA-regulated products, a c=0 sampling plan is appropriate. See H1331 Zero Acceptance Number Sampling Plans, Fifth Edition, by Nicholas L. Squeglia
  • Based on risk, an Acceptable Quality Level (AQL) should be selected
  • Your sample size is usually set to be proportional to lot size.  If you are doing testing on bulk raw materials, the sample size will be set based on the variability of the lot as well as the variability of the method.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ CQE
Principal Statistician, BD
http://statisticaloutsourcingservices.com/

Note:

 *military standard, cancelled and superceded by MIL-STD-1916, “DoD Preferred Methods for Acceptance of Product”, or ANSI/ASQ Z1.4:2008, according to Notice of Cancellation

More open access resources about sampling from ASQ:

Explore more in the ASQ Knowledge Center.

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2 Responses to Sampling Plan for Pharmaceuticals

  1. Bjarne Lykkegaard says:

    So how to use ISO 2859 on roll goods ? If I produce 10.000 labels, and all the labels is in one single roll, how should I then take the samples ? If the reject/accept criteria in the sample plan should be reliable, then the following must be true:
    – Random sampling is carried out
    – Each item has an equal probability of being selected during sampling

    This is not possible on roll goods, so should I skip the inspection of roll goods ? Taking a look at the labels at the end of the roll make no sense, the inspection result isn´t representative

    • Hi Bjarne,

      Please submit your question using the form located on the “About & Ask A Question” page, which is accessible from the menu bar at the top of the blog. The form will ask you for your contact information, which we will need in case the expert needs clarification and for us to respond to you.

      Thank you — Megan, ASQ Ask the Experts Team

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