Excipient certification scheme takes off

EXCiPACT is a new certification scheme for pharmaceutical excipient manufacturers and distributors. Dr Iain Moore, co-ordinator of the EXCiPACT Global Steering Committee and product and QA manager, Croda Europe, outlines how it will work.

The new, voluntary international pharmaceutical excipient cGMP and cGDP certification scheme is designed to help enhance patient safety and supplier quality, as well as minimising overall supply chain costs through the sharing of available information.

EXCiPACT is an independent, non-profit legal entity, registered in Brussels. Since 2008, it has been developed as a project via a consortium of industry experts from the European Fine Chemical Group (EFCG), the European Association of Chemical Distributors (FECC), the International Pharmaceutical Excipients Council (IPEC) Europe, IPEC-Americas, and the UK Pharmaceutical Quality Group (PQG).

The mission is for EXCiPACT to become the preferred global organisation that supports certification for pharmaceutical excipient manufacturers, suppliers and distributors. The vision is for the scheme to be a voluntary, self-regulated initiative of the global pharmaceutical excipient manufacturing, distributing and pre-formulating industry, supported by excipient users. It is a scheme that:

• ensures current good manufacturing practice (cGMP) and current good distribution practice (cGDP) requirements are applied to pharma excipients through a recognised auditing and certification process, thereby increasing safety and reliability as well as transparency of the supply chain
• has, as a key part of this process, the approval by a panel of experts independent of the audit, which assures the certification meets the expectation of users and the regulators
• is accepted by all major stakeholders, including relevant authorities globally
• is an independent organisation able to objectively set cGMP and cGDP standards today and in the future
• provides certification as a cost-efficient method of ensuring cGMP and cGDP are applied throughout the pharmaceutical supply chain by reducing the audit burden.

The four key objectives developed by the EXCiPACT project team at the outset were:

• cGMP and cGDP standards for pharma excipient manufacture and distribution that are suitable for third party auditing
• definition of third party auditor competency
• definition of training requirements for third party auditors
• establishment of certification scheme rules for third party audit organisations resulting in an EXCiPACT certificate for pharmaceutical excipient manufacturers (cGMP) and distributors (cGDP)

development background

The concept of EXCiPACT came into being when, in 2008, a group of industry experts from the EFCG, IPEC Europe, IPEC-Americas, the FECC and the PQG worked together as a consortium on the development of a certification scheme for pharmaceutical excipient suppliers.

All these parties are in agreement that an international pharmaceutical excipient cGMP and cGDP certification scheme is a tool that helps to ensure the quality and reliability of these key ingredients for medicinal products throughout the supply chain.

The draft EXCiPACT cGMP and cGDP standards were made available for public and stakeholder review between March and June 2011. These standards have been based on the well-known and widely accepted IPEC-PQG GMP and the IPEC GDP Guides.

All submitted comments were reviewed and amendments made to create the final version, which was due to be published as Issue No.1 this month.

Third party auditor training is also scheduled to start this month, followed by a pilot study to complement the overall launch process. As the EXCiPACT standards act as Annexes to ISO standards 9001, 19011 and 17021, organisations already ISO certified will find it very effective to extend their ISO certification to the EXCiPACT standards.

Alternatively, suppliers who do not hold ISO 9001 certification can obtain an equivalent certificate through the forthcoming US national standard (ANSI-NSF 363), which has been developed in co-ordination with the EXCiPACT cGMP standard. All suppliers, therefore, have the choice of which certification route to follow. In either case, the requirements are the same.

EXCiPACT is initially targeting both the European and North American markets with other interested countries to follow as soon as possible afterwards. It is hoped that the scheme will provide for a safe, reliable, transparent pharmaceutical supply chain and cost savings by reducing the audit burden for both customer and supplier without sacrificing quality.

The scheme will offer the following products:

• Approval/qualification of third party audit companies issuing the EXCiPACT certificate
• Excipient GMP Annex to ISO 9001 and/or ANSI standard
• Excipient GMD Annex to ISO 9001 and/or ANSI standard
• Requirements for auditor competency and third party audit organisations providing certification

It will also offer the following services:

• Oversight of pharmaceutical excipient manufacture and distribution certification
• Auditor competency development and qualification
• Website with certification status

certification process

Figure 1 outlines the certification process and the relationship of the different players.

The EXCiPACT project team has provided an estimation of the potential cost savings based on their combined experience and practice within the industry in Figure 2. These are not guaranteed and each potential user must undertake his own assessment before initiating an EXCiPACT certification.

In conclusion, EXCiPACT offers the pharmaceutical supply chain the opportunity to access a new, independent international pharmaceutical excipient cGMP and cGDP certification scheme to help set minimum standards, qualify suppliers, minimise overall supply chain costs and thereby enhance patient safety.