Standard di settore

Beckman Coulter Life Sciences è un nome che ispira fiducia a laboratori, università, ospedali e stabilimenti di produzione di tutto il mondo, conosciuto per il suo impegno ad aiutare i propri clienti a mantenere la conformità con gli standard stabiliti da tutti i governi e da tutte le agenzie pertinenti.

EU GMP Annex 1

Guidance for the manufacturing of sterile medicinal products

EU IVD-Regulation (IVDR)

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

ICH Q2

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

USP <1046>

Standards for Cell and Tissue-Based Products

USP <643>

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

ISO 11171

Liquid particle counting calibration and performance guidelines for acceptable operation

ISO 14644

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

21 CFR Part 11

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

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). 

ISO 21501

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

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.

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 <788>, <787> and EP2.9.19

Defining allowable limits of sub-visible particulates in parenteral formulations

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. 

USP <790>

Guidance on visible particulates in products intended for parenteral administration 

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