The product is manufactured by Shell according to Good Manufacturing Practices principles of the International Pharmaceutical Excipients Council (IPEC). There are special procedures in place at the manufacturing site to achieve GMP compliance and a GMP program is ongoing to improve compliance with these principles permanently. The latest GMP audit has been performed by a Qualified Person of Hedinger at the manufacturing facilities in March 2019. A report is available for customers after signature of a Confidentiality Agreement.

  • Manufacturing fulfils IPEC-PQG GMP Guideline for Pharmaceutical Excipients
  • Dedicated process equipment
  • Filtration before loading to avoid particles
  • Full traceability to raw materials and their analytical data

Isopropyl Alcohol GMP Ph. Eur./USP/JP

  • Full analysis according to Ph. Eur., USP and JP in a GMP laboratory in compliance with EU-GMP Part I, Chapter 6
  • Cleanrooms according to EU-GMP Part I, Annex 1 and ISO 14644 filling Class D (100,000) / ISO 8
  • Purity of Isopropyl Alcohol GMP Ph. Eur./USP/JP ≥ 99.80 %
  • Compliance with Ph. Eur., USP and JP
  • Bulk transport in dedicated Hedinger tank trucks
  • No risk of contamination from BSE/TSE (bovine spongiform encephalopathy/transmissible spongiform encephalopathy)
  • No risk of contamination from GMO (genetically modified organism)
  • Virtually free from aflatoxins
  • Virtually free from allergens
  • Fulfils ICH residual solvents guidelines
  • Tested for elemental impurities according to guideline ICH Q3D
  • Detailed impurity profile available
  • Isopropyl Alcohol 70 % (V/V)
  • Isopropyl Alcohol 70 % (V/V) API grade / USP
  • Isopropyl Alcohol 70 % (V/V) G25 sterile filtered

These grades are notified as biocidal product according to national regulations in Germany, Austria and France. The application for authorisation according to the Biocidal Product Regulation (EU) No 528/2012 has been submitted in due time for these countries. In all three countries the product can be used as surface and skin disinfectant.

  • Isopropyl Alcohol GMP Ph. Eur. / USP / JP

Produced by Shell according to IPEC-PQG GMP and batchwise fully tested in a GMP laboratory according to the respective pharmacopoeial monographs by Hedinger. For this biocidal active ingredient Hedinger is listed on the Article-95-List (List of active substances and suppliers) of the European Chemical Agency ECHA and an approved supplier. Isopropyl Alcohol GMP Ph. Eur. / USP / JP can be used as an active ingredient for the manufacture of biocidal products.

Isopropyl Alcohol 70 % (V/V) API grade and Isopropyl Alcohol 70 % (V/V) API grade/USP are produced by Hedinger according to the following API relevant standards:

  • Raw material compliance (Isopropyl Alcohol GMP Ph. Eur./USP/JP: IPEC-PQG GMP, Purified Water Ph. Eur./USP: EU-GMP Part I)
  • Preparation of the aqueous solution according to EU-GMP Part II (ICH Q7)
  • Customer-specific solutions of Isopropyl Alcohol GMP Ph. Eur./USP/JP with Purified Water Ph. Eur./USP (1–99 %)
  • Qualified water-purification system according to GMP
    • Validated manufacturing process
    • Regular monitoring of water quality according to Ph. Eur. and USP
      • Microbiology/Endotoxins
      • TOC (qualified according to Ph. Eur. and USP)
      • Conductivity
      • Pharmacopoeia monographs
  • Dilution processes in accordance with GMP
    • Head of manufacturing is responsible for process
    • Validated process
  • Full GMP documentation

 

Water purification system at Hedinger:

The product 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
  • Standard quantities (1 L – 1,000 L)
  • Qualification of the HVAC (Heating, Ventilation & Air-Conditioning) system according to EU-GMP Part I, 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)

The Quality control department of Hedinger is running a full monograph testing according to current Ph. Eur., USP and JP under full GMP conditions and releasing every delivered batch by a Qualified Person according to EU-GMP. A Certificate of Analysis by a Qualified Person with all Ph. Eur., USP and JP data will be provided with every delivery.

  • Full analyses according to Ph. Eur., USP and JP
  • GMP laboratory in compliance with EU-GMP Part I, Chapter 6
    • GMP documentation of analytical results
    • Equipment qualification and maintenance
    • Out-of-specification result investigations
    • Qualification of standards and reference materials
    • Batch documentation and shelf life control of reagents
    • Regular qualification and requalification of personnel
    • Stringent pharmacopoeia revision management
    • Method validation according to ICH Q2
  • Transport in dedicated tank trucks
  • 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
  • Quality assurance agreements with warranty of specification including
    • Change control agreement
    • Regulatory information
    • Extended liability
  • GMP-Audit report by a Qualified Person about the manufacturing site available for customers after signing a Confidentiality Agreement
  • Customer-specific on-site audit dates at packaging site
  • Customer-specific questionnaires, regulatory confirmations and information
  • Customer-specific quantities per container
  • Customer-specific labelling (customer’s data)
  • Transfer of analytical raw data (chromatograms etc.)

 

Isopropyl Alcohol (IPA-GMP)

Different grades of Isopropyl Alcohol

Isopropyl Alcohol GMP Ph. Eur. /USP/JP

Isopropyl Alcohol 70% (V/V) API grade

Isopropyl Alcohol 70 % (V/V) API grade/ USP

Isopropyl Alcohol 70% (V/V) G25 sterile filtered

Isopropyl Alcohol for use as biocidal product and biocidal active

Customer-specific aqueous solutions of Isopropyl Alcohol

For further information, please contact ipa-gmphedingerde.

We would also welcome your telephone call.

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