Quality Metrics Pilot Program: Detailed Metrics Definitions(二

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Quality Metrics Pilot Program: Detailed Metrics Definitions(二)2014-12-02 [url=]ISPE[/url]

上周，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:

9, APQR reviews on time
APQR reviews completed on time = Number of Annual Product Quality Reviews in the period that were completed by the original due date, normalized by all products subject to APQR

Definition
▪ Products subject to APQR = Total number of products subject to Annual Product Quality Reviews - annual evaluations of the quality standards of each drug product to verify the consistency of the process and to highlight any trends in order to determine the need for changes in drug product specifications or manufacturing or control procedures (as required by CFR Sec. 211.180, General requirements, section (e) and ICH Q7, GMPs for APIs, section 2.5 or EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Chapter 1, Pharmaceutical Quality System, section 1.10). Does not include the data packages that a site prepares to its customers when acting as a CMO

▪ Number of Annual Product Quality Reviews on time = completed by the original due date

10, Recurring deviations rate
Recurring deviations rate = Number of deviations that have re-occurred during the preceding 12 month period out of all closed deviations

Definition
▪ Number of deviations = Any major or minor unplanned occurrence, problem, or undesirable incident or event representing a departure from approved processes or procedures, also includes OOS in manufacturing or laboratory or both. Please count only deviations that have been closed/resolved in the period. Deviations from one period, for which the investigation was closed in the next period, should be counted in the latter period.

▪ Recurring deviations = Number of deviations for which during the 12 month period preceding each deviation, at least one other deviation has occurred with the same root cause within the same process and/or work area. If redundant/duplicative processes or equipment exist, please consider deviation events common to the grouping/work center as recurring (still within the 12 month timeframe). For example, if a deviation for missing desiccant occurs twice, on two separate packaging lines with comparable equipment/systems, it should be counted as recurring (i.e. as 2 "same" deviations, rather than 1 "different" for each line)

11, CAPA effectiveness rate
CAPA effectiveness rate = Number of CAPAs effective out of all CAPAs with effectiveness check in the reporting period

Definition
▪ CAPAs with effectiveness check = Number of CAPAs evaluated for effectiveness in the reporting period. All CAPAs should be counted, including those related to inspection or audit observations

▪ CAPAs effective = those evaluated CAPs where the quality issue subject of the CAPA was resolved, and/or has not reoccurred, and there have been no unintended outcomes from the CAPA implementation

12,Media fill rate (sterile/aseptic only)
Media fill rate = Number of media fills dispositioned as successful out of all media fills to support commercial products dispositioned during the period

Definition
▪ Media fills = Total number of media fills (regardless of number of runs in each) to support commercial products that were dispositioned (as successful or failed) during the period. If the media fill was dispositioned as failure and a rerun was needed, that repeat is counted as a separate media fill. Includes all media fills - both for initial and periodic qualifications

▪ Successful media fills = All media fills that were not dispositioned as failures

13,Environmental monitoring (sterile/aseptic only)
Environmental monitoring
– ots with action limit excursions, normalized by all sterile dispositioned lots
– Lots rejected due to environmental monitoring reasons, normalized by all sterile dispositioned lots

Definition
▪ Sterile dispositioned lots during the period (see definition for Lot acceptance rate)

▪ Lots with limit excursions = All sterile dispositioned lots during the period that had associated investigations related to exceeding environmental monitoring action limits. If a lot had more than 1 such investigation please count only 1 per lot. If an investigation has affected multiple lots, please count each lot separately. Action limit is an established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation)

▪ Rejected lots due to environmental monitoring reasons = All sterile dispositioned lots during the period that were rejected for exceeding environmental monitoring action limits. 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

14,Process capability questions

Quality culture dimensions

fruutuun

昨天发错了标题！{:soso_e113:}致歉！

gyxleo

谢分享。