Quality Metrics Pilot Program

fruutuun

昨天，我们与大家分享了ISPE质量指标项目的最新进程。为了响应FDA提出的如何衡量药品质量，即质量量度，ISPE提出了一些指标,并对这些指标做出了详细的说明和解释。

Quality Metrics Industry Pilot

Metrics details:

1, Lot acceptance rate
Lot acceptance rate = Total lots released for shipping out of the total finally dispositioned lots for commercial use in the period

Definition
▪  Total lots dispositioned = total number of lots for commercial use produced and/or packaged on site that went through final disposition during the period, i.e. were released for shipping or rejected (for destruction). Rejections should be counted as final disposition regardless at what production stage the rejection occurred. Release is only final release for shipping. Excludes lots that have been sent for rework or put on hold/quarantined in this period and hence are not finally dispositioned. Excludes lots that are not produced or packaged on site, but just released for CMOs.

▪ Total lots rejected = total full lots were rejected for quality reasons. Rejected means intended for destruction or experimental use, not for rework or commercial use. Rejections should be counted regardless at what production stage the rejection occurred

▪ Total lots released (“accepted”) = total lots dispositioned less total lots rejected

2, Total complaints rate
Total complaints rate = Total complaints received in the reporting period, related to the quality of products manufactured in the site, normalized by the number of packs released

Definition
▪ Packs released = Total number of packs (final product form that leaves the plant, one level less than tertiary packs, most usually it is secondary packaging unit e.g. pack of blisters or bottle in carton pack) released in the period

▪ Total complaints = All complaints received in the reporting period, related to the quality of products manufactured in the site, regardless whether subsequently confirmed or not. All complaints received by the site should be counted, even if a complaint affects more than 1 site, or if eventually the root cause analysis attributes the issue to another site. Complaints related to lack of effect should be counted as well

3, Critical complaints rate
Critical complaints rate = All critical complaints, normalized by the number of packs released

Definition
▪ Critical complaints = Complaints which may indicate a potential failure to meet product specifications, may impact product safety and could lead to regulatory actions, up to and including product recalls. Critical (or expedited) complaints are identified upon intake, whether subsequently confirmed or not, based on the description provided by the complainant, and include, but may not be limited to:
– i. Information concerning any incident that causes the drug product or its labelling to be mistaken for, or applied to, another article.
– ii. Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application.

4, Confirmed OOS rate
Confirmed OOS rate = Total confirmed OOS (test results that fall outside the specifications or acceptance criteria), out of all lots dispositioned by the lab during the period

Definition
▪  Total lots tested/dispositioned by the lab = total number of lots used for commercial production that are tested and dispositioned out of the lab in the period, i.e., have a QC pass or fail decision on them. Includes:

– Lots for release testing (counted as 1 lot, even if sampled separately for chemical and microbiological testing, or for in-process analytical testing in lab or on shop floor)

– Lots of incoming materials for analytical testing (count 1 per each analytically tested raw material and/or packaging material lot). Includes water used as raw material.

– Lots for stability testing in that period (counted as 1 per each timepoint and condition sampled per the approved stability protocol)

– Does not include environmental monitoring samples

▪ Confirmed OOS = all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, formulary or applied by the manufacturer when there is not an ‘official’ monograph

5, Stability failure
Stability failure = Total confirmed OOS related to stability testing

Definition
▪ Subset of the “Confirmed OOS rate” – based on stability lots tested and confirmed OOS related to stability only

6, Invalidated (unconfirmed) OOS rate
Invalidated (unconfirmed) OOS rate = Total unconfirmed OOS, out of all lots tested during the period

Definition
▪ Unconfirmed OOS = all OOS minus confirmed OOS (see the definition of confirmed OOS)

7. Recall rate
Definition
▪ Recall events = all US market recall events
▪ By class = all US market recall events, class I and II
▪ Recalled lots = Include lots recalled either voluntarily or by regulatory order (recall implies physical removal of product from field, not just a field action or correction). Include US market recalls only

8. Right first time (rework/reprocessing)
RFT (rework/ reprocessing rate) = Total lots that have not been through rework or reprocessing out of the total finally released lots for commercial use in the period

Definition
▪ Total lots released (“accepted”) = total lots dispositioned less total lots rejected (see the definition of Lot Acceptance Rate)

▪ Total lots reworked or reprocessed = all lots that have gone through rework (using alternative process) or reprocessing (using again the original process) before that final disposition in order to meet requirements for release. Only count rework or reprocessing necessitated by quality issues (for example contract manufacturing sites should exclude rework due to customer order changes). If a lot was sent for rework and received a new lot number, it should still be counted as undergone rework when finally dispositioned.

未完待续

愚公想改行

真是好东西！可惜英语都还给老师啦！若有译文该多好啊！

残伤

英语不行  来点翻译

魅力暴君

高大上，高难度，大文章，上不去啊

airforcer

感谢分享，谢谢