Line 222–223, “PQCR = the number of product quality complaints received for the product divided by the total number of dosage units distributed in the current reporting timeframe.”
222–223行，“产品质量投诉率（PQCR）=报告期内，产品收到的质量投诉数，除以同一报告期内放行的剂量单位总数。”
Comment:
1. If the product Z is not produced in the current reporting timeframe but complaints are received for the batches produced in the previous reporting timeframe, shall the complaints be counted in the current timeframe or be updated in the previous? If counted in the current timeframe, the PQCR will have zero as denominator.
2. For API products, the complaints are potentially more often on a whole batch than a portion of a batch. Thus, for manufacturers producing the same API product with a same number of batches per year, the manufacturer with a larger batch size may naturally have a lower PQCR, since the numerator is identical while a larger batch size means a larger denominator. For example, for the same API product, manufacturer X produces 10 batches a year with a batch size of 10kg, and manufacturer Y produces 10 batches a year with a batch size of 100kg. Both of the manufacturers receive one compliant on one batch. The PQCR of manufacturer X will be 10 times of that of Y.
Line 226–229, “IOOSR = the number of OOS test results for lot release and long-term stability testing invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results in the current reporting timeframe.”
226–229行，“无效OOS率（IOOSR）=报告期内，批次放行检验和长期稳定性检验的OOS结果中，因检验过程中的过失而被涵盖设施判定无效的OOS个数，除以同一报告期内批次放行和长期稳定性检验的全部OOS个数。”
Comment:
1. If the investigation shows the OOS is caused by QA/QC sampling aberration instead of QC testing, should the OOS be counted as an invalidated OOS test result?
2. If the OOS investigation fails in finding the root cause, and the batch is finally released based on statistically sound retesting and totality of evidence, should the OOS result be counted and should it be counted as an invalidated OOS test results?
Line 320, “Specific criteria for the IOOSR data”
320行，“无效OOS率（IOOSR）数据具体标准”
Comment:
If five samples from five lots for five lot release tests are prepared in a row, and the sample preparation was incorrect for all the samples, thus resulting in five OOS test results, should it be counted as five OOS test results and five invalidated OOS test results, or one OOS test results and one invalidated OOS test results, considering the five mistakes made are actually sharing the same root cause.
Line 644–646, “Product Quality Complaint – a complaint involving any possible, including actual, failure of a drug to meet any of its specifications designed to ensure that any drug conforms to appropriate standards of identity strength, quality, and purity.”
644–646行，“产品质量投诉——涉及药品任何可能的，包括事实上未能符合其质量标准的投诉。质量标准的设计确保了任何药品符合恰当的鉴别、规格、质量和纯度。”
Comment:
1. If the API or intermediate manufacturer receives a quality complaint from the finished product manufacturer, and the investigation eventually shows the issue actually caused by the latter. Should the complaint still be counted as a product quality compliant on the API or intermediate manufacturer?
2. If the API or intermediate manufacturer produces products with the same process and standards, and delivers the products to five finished product manufacturer clients. The API manufacturer receives one quality complaint from one of its five clients, indicating the product does not meet its in-house purchasing standards, which is much tighter than the USP as well as that of the other four clients. Should this complaint be counted as a quality compliant that involves possible or actual failure of the drug to meet its specifications designed to ensure that the drug conforms to appropriate standards of identity strength, quality, and purity?
Line 673, “Appendix A.1: Applicable Inputs for a Product Report Submission, Application Product, Finished Drug Product”
673行，“附录 A.1: 提交产品报告，申报产品，成品药品填写适用”
Comment:
1. For product reporting establishments owning and manufacturing the product, none of the four rows in the table seems applicable. Consider to add a new row for this circumstance.
2. Please provide examples and demonstrations for the Appendix A tables.
Comment:
1. Please provide examples in the context of API and intermediate manufacturing, especially for Lot Acceptance Rate and Product Quality Complaint Rate.
2. Specifically, for the Lot Acceptance Rate, how to define packaging product lots for API and intermediate?
