IPA-GMP¹grade

IPA is a versatile, cost effective solvent that can be used in the preparation of a number of pharmaceutical products such as medicinal tablets, as well as in disinfectants, sterilisers and skin creams. To meet GMP standards, a quality control system has to be implemented that covers the manufacturing, storage, supply and distribution of product destined for these applications.

The IPA-GMP¹grade is being specifically marketed in Europe, although GMP standard material is also available in North America.

1meets excipient level of GMP

Our customer offer

• Shell Chemicals Europe is the first supplier of GMP-compliant product in Europe, with product being manufactured at Pernis, The Netherlands
• Control and traceability measures are in place throughout the supply chain to ensure GMP compliance
• Introduction of the grade is supported by full training programmes for staff, hauliers and customers
• Shell chemicals companies are among the global leaders in the solvents sector and committed to adhering to the principles of Responsible Care

What is IPA-GMP¹?
IPA-GMP¹ is the name given to a specific grade of IPA that is being marketed in Europe to the pharmaceutical, food and cosmetics sector. Its introduction follows the adoption of Good Manufacturing Practice (GMP) standards for IPA production at the Pernis manufacturing facility in The Netherlands. GMP standard material is also available in North America.

How is IPA-GMP¹ used?
IPA is a versatile, cost effective solvent that can be used in the preparation of a number of pharmaceutical products such as medicinal tablets, as well as in disinfectants, sterilisers and skin creams.

GMP guidelines have been developed in order to guarantee the quality of finished pharmaceuticals as well as both the active and non-active chemicals used in their manufacture. GMP compliance has been a legal requirement in Europe since 2005 for active ingredients and although not yet mandatory for non-active ingredients (excipients) this is expected to change in the future.

What are our key strengths as a supplier of IPA-GMP¹?

• Shell Chemicals Europe is the first supplier of GMP-compliant product in Europe, with product being manufactured at Pernis, The Netherlands
• Control and traceability measures are in place throughout the supply chain to ensure GMP compliance
• Introduction of the grade is supported by full training programmes for staff, hauliers and customers
• Shell chemicals companies are among the global leaders in the solvents sector and committed to adhering to the principles of Responsible Care

1meets excipient level of GMP

The introduction of Good Manufacturing Practice (GMP) for IPA required physical changes to be made at the Pernis facility, to eliminate the risk of contamination.

The more extensive quality data that is collected for this product is included in additional documentation that can be provided with each delivery, while the product’s GMP status is also identified on the certificate of analysis.

Dedicated road tankers are used to transport IPA-GMP¹ so there is no potential for product mix-ups and no need for cleaning between deliveries, which further reduces the risk of contamination.

To maintain the integrity and traceability of the product, quality measures are also in place while the product is en route and at the customer’s premises.

The implementation of the GMP system has required a major training programme for plant, sales and customer service staff, as well as hauliers. Similar training will be provided to customers to ensure they fully understand the GMP requirements and have the appropriate measures for product reception in place.

1meets excipient level of GMP