Compliance with WHO/IPEC Good Distribution Practice Guide for Pharmaceutical Excipients

  • Full traceability through documentation of the entire supply chain
  • Prevention of cross-contamination through appropriate GMP handling and use of dedicated equipment
  • Ideal storage conditions

 

Transparent and short supply chain

 

Butylhydroxytoluene (BHT) is repackaged by Hedinger under clean room conditions into customized packaging sizes following IPEC-PQG GMP requirements for excipients:

  • Cleanrooms according to EU-GMP Part I, Annex 1 and ISO 14644
  • Class D (100.000) / ISO 8
  • Qualification of the HVAC(Heating, Ventilation & Air-Conditioning) system according to EU-GMP PartI, annex 15 and ISO 14644
  • Regular validation of cleanroom conditions (monitoring)
    - Airborne particles
    - Microbiology
  • State-of-the-art preventive maintenance of HVAC systems
  • Hygiene program for staff and premises
    - Regular hygiene training
    - Monitoring of staff health
    - Appropriate gowning and sanitation practices
  • Qualified packaging material
    - Audited suppliers
    - Defined specifications
    - Incoming inspection with verification of key quality
      parameters and batch release
  • No reuse of primary packaging materials (except stainless steel IBCs)

Aquatic Acute 1, H400 Aquatic Chronic 1, H410

  • Purity ≥ 99.0 %
  • Compliance with Ph. Eur., USP and JPE
  • No risk of contamination from BSE/TSE (bovine spongiform encephalopathy/ transmission spongiform encephalopathy)
  • No risk of contamination from GMO (genetically modified organism)
  • Virtually free from aflatoxins
  • Virtually free from allergens
  • Fulfills ICH residual solvents guidelines

 

 

Pharma

Butylhydroxytoluene (BHT) Ph. Eur./USP (NF)/JPE

Butylhydroxytoluene (BHT) GMP Grade Production Overview

  • Manufactured by LANXESS at a dedicated facility in Leverkusen, Germany
  • Manufacturing complies with requirements of IPEC-PQG GMP Guidelines for Bulk Pharmaceutical Excipients
  • Dedicated process Equipment
  • Full traceability to raw materials and their analysis data

 

GMP (Good Manufacturing Practices)

Butylhydroxytoluene (BHT) is manufactured by LANXESS based on IPEC PQG GMP Guidelines. There are special procedures in place at the manufacturing site to achieve this compliance and a program is ongoing to improve compliance permanently.

 

Hedinger's testing, release and repackaging of Butylhydroxytoluene (BHT) Ph. Eur. /USP(NF)/JPE

  • Testing in the Hedinger GMP Quality Control Laboratory according to Ph. Eur., USP and JPE using test methods of the pharmacopoeias
  • Batch release by a Qualified Person according to EU-GMP

Specification Butylhydroxytoluene (BHT) Ph. Eur./ USP(NF)/JPE

Download Specification

For further information, please contact bhthedingerde.


We would also welcome your telephone call

Aug. Hedinger GmbH & Co. KG  
Headquarters in Stuttgart, Germany
phone: +49 - (0)711 - 40 20 50