Regulatory Compliance

Celsis Rapid Detection delivers proven technologies used by many of the world's top pharmaceutical and personal care companies 

• Pharmaceutical customers worldwide have incorporated Celsis Rapid Detection systems into their regulatory proposals, including many successful NDA, sNDA, and sBLA submissions

• Two drug master files (DMFs) for Celsis AKuScreen and RapiScreen reagents are on file with the FDA; Celsis customers can expedite the regulatory approval process by referencing a DMF

• Our Advance.im and Innovate.im system software packages meet the requirements of 21 CFR Part 11 compliance

Celsis Rapid Detection products and services have delivered significant cost savings and improved quality control to many companies with regulated ingredients and/or products. We keep current with the ever-changing global regulatory environment through active engagement with leading industry organizations and regulatory bodies including:

• U.S. Food and Drug Administration (www.FDA.gov)
  • Including CDER, CBER and CDRH

• Parenteral Drug Association (www.PDA.org)

• Personal Care Products Council (www.personalcarecouncil.org)

• International Commission on Harmonization (www.ICH.org)

• European Medicines Agency (www.emea.europa.eu)

• Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk)

• Ministry of Health, Labour and Welfare (www.mhlw.go.jp)

• United States, European Union and Japan Pharmacopeias (USP, EP, JP)

Celsis Regulatory Services

Celsis takes an active role in regulatory discussions with agencies and our customers around the world. We have dedicated regulatory compliance personnel and resources available to consult and assist with the implementation of Celsis Rapid Detection systems for your products and materials

PDA Technical Report

In a joint collaboration with numerous industry leaders and regulators, Celsis actively participated in the Parenteral Drug Association (PDA) Task Force on Rapid Microbiological Methods. Published as the PDA Technical Report No. 33, The Evaluation, Validation and Implementation of New Microbiological Test Methods, this guide is used by industry and regulators as the "best practice guide." This document has strongly influenced USP Chapter <1223> Validation of Alternative Microbiological Methods and EP Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality

ICH Harmonization

For information about recent changes to the USP <61> Microbial Enumeration Tests, and the addition of USP <62> Tests for Specified Microorganisms, view FAQs from our webcast on The Impact of Harmonizing Microbial Testing, which featured a discussion by industry and regulatory experts on how to implement the changes effective 1 May 2009. These chapters harmonize with corresponding chapters in the European and Japanese Pharmacopeias. Additional resources are here: Changes to the USP.