分类或分组年度回顾

beiwei5du

The EU PQR states that "Quality reviews may be grouped by product type (e.g., solid dosage forms, liquid dosage forms, sterile products) where scientifically justified." FDA prohibits the grouping of different products despite their production using similar processes, or any other similar approach, because the uniqueness of each production process and product specification may result in different manufacturing outcomes (9).

The EU PQR allowance for grouping product types opens up the possibility to consolidate the review for a number of drug products and take a "modular approach" to the information gathering and review process. The modular approach involves using currently established systems, to the greatest extent possible, to provide summary data and information across a product type to satisfy the requirements of the PQR. For example, to meet the requirement to review starting and packaging materials, the modular approach involves querying established systems to provide summary data for all raw materials within a product type and then performing a consolidated review, identifying any trends and specific actions for the product type. The same approach could be used for marketing authorization (MA) variations, change control, stability, product returns, complaints and recalls, equipment qualification, and the technical agreement reviews that are required by the EU PQR. The PQR data mining starts with a product type review with individual products highlighted as necessary to support any trends and/or identify any product or process improvements. It is important that this approach is scientifically justified and that this justification is documented. Several criteria that may be relevant in providing such justification include:

• The PQR topic under review crosses individual product boundaries.
• There are established systems with reporting functionality by product type.
• The trending is more relevant across product types versus individual products.
• The individual product details are not lost during product type reviews.
• There is a concentration of product types at a given manufacturing site.
  

静水蓝心

Thanks for sharing！

beiwei5du

静水蓝心 发表于 2016-10-30 16:12
Thanks for sharing！

不用谢，希望大家多多分享，周末愉快！

麦田.守望

原文来自：
http://www.pharmtech.com/view/pr ... and-interpretations

补充内容 (2023-2-20 19:13):
https://elsmar.com/elsmarquality ... duct-reviews.67765/