行业标准与法规要求

作为全球实验室、大学、医院和制造设施中可信赖的品牌，贝克曼库尔特生命科学致力于帮助我们的客户合乎政府和机构制定的标准额规定。

EU IVD-Regulation (IVDR)

IVDR is a marathon, not a sprint. We will help you go the distance.

21 CFR Part 11

规定必须生成和防护电子记录的条件

USP <1046>

Standards for Cell and Tissue-Based Products

USP <788>, <787> and EP2.9.19

Defining allowable limits of sub-visible particulates in parenteral formulations

USP <787>

Particle counting analysis techniques for measuring contamination and specifying limits

ALCOA

ALCOA defines good data integrity practice as creating records that are attributable to the technician carrying out the testing, are legible, are created contemporaneously, original and accurate.

EU GMP Annex 1

Guidance for the manufacturing of sterile medicinal products

ISO 21501

For determination of particle size distribution for single-particle light-interaction methods

ISO 11171

Liquid particle counting calibration and performance guidelines for acceptable operation

ICH Q2

Is an expert working group with representation from the United States, European and Japanese Pharmacopoeias. 

USP <643>

表示用于制药应用的水中总有机碳 （TOC） 测量的通用方法

ISO 14644

Cleanliness in cleanrooms and clean zones, addressing specifications and rules for certification

ISO Regulations

The Switzerland-based International Organization for Standard (ISO) is a non-governmental, independent consortium of 165 member countries working toward a common set of goals.

USP <790>

Guidance on visible particulates in products intended for parenteral administration 

EP 2.2.44

Chapter 2.2.44 of the European Pharmacopoeia describes the procedures used to qualify a chosen method for analyzing total organic carbon (TOC)—and the interpretation of results in limit tests. 

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