Recommended AQLs for Packaging Material in the Pharmaceutical Industry


Question:

Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry?
Thank you

Response:

Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to surface. The following table is a guideline that I have seen used successfully for a risk based approach to sampling. Based on the severity and criticality of the packaging materials, these guidelines can be adjusted up to down per your risk management process.  Utilizing a c=0 sampling plan based on the binomial distribution, the sample size can be calculated using the following formula.

 

Primary

Secondary

Confidence (%)

Reliability (%)

Sample Size

Confidence      (%)

Reliability (%)

Sample Size

Critical

99.5

99

527

99

97

151

Major

99

97

151

97

95

68

Minor

97

95

68

95

90

28

I hope this assists you.

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

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