Inspection Attributes in Packaging Validation of Non-Sterile Drug Products

An important aspect of AQLs and UQLs is the continuous learning and possible
adjustments of defect descriptions and levels. Failure to meet established defect limits is
investigated to determine the impact on validation. As events and history of the packaged
product and process are gained, changes may be warranted. Re-evaluation of the attribute
description (e.g. quantitative measurements enhanced or more specific description of the
defect) and acceptability by the Quality Unit of that defect and corresponding acceptance
criteria may be beneficial. Trending, quality incidents and investigations and statistical
treatment of inspection data are a means to review the defects. Quality risk management
tools may also be used to provide a basis for evaluating the potential impact of package
defects.
Definitions of classifications:
Common defect classification criteria for critical, major and minor and its impact on the
safety, regulations, use, consumer relations and company are shown in Appendix I.
Sampling Plans:
Typical sampling plans that can be used are General Inspection Level II (ANSI/ASQC
Z1.4-1993), with Single, Normal Sampling Plan or ISO 2859-4 (10). Other sampling
plans may be appropriate depending on administrative difficulty of the ensuing sample
size, desired or given AQL, sample size of the available plan, packaging history and
routine monitoring intentions.
Sample size of multiple plans is less than double sampling plans, which in turn is less
than the single sample plans. Once determined, the total sample size is divided by the
number of sampling intervals to determine the number of samples per interval (e.g. 200
bottles (sample size) /24 intervals = 9 bottles/interval).