Industry Standards

As a trusted name in labs, universities, hospitals and manufacturing facilities across the globe, Beckman Coulter Life Sciences is committed to helping our customers maintain compliance with standards established by all applicable governments and agencies.

EU GMP Annex 1

Guidance for the manufacturing of sterile medicinal products

ICH Q2

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

ISO 11171

Liquid particle counting calibration and performance guidelines for acceptable operation

EU IVD-Regulation (IVDR)

IVDR 2022 is a marathon, not a sprint. We will help you go the distance.

ISO 14644

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

ISO 21501

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

21 CFR Part 11

Mandates the conditions under which electronic records must be generated and defended

USP <643>

Represents the general method for measuring total organic carbon (TOC) in water used for pharmaceutical applications

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 <645>

This standard applies to electrical conductivity, one of four critical water quality attributes defined by the United States Pharmacopeial Convention (USP) for purified water (PW) and water for injection (WFI). 

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.

USP <787>

Particle counting analysis techniques for measuring contamination and specifying limits

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

Defining allowable limits of sub-visible particulates in parenteral formulations

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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