SGS and blue inspection body to be excipact trained

By Gareth Macdonald

- Last updated on GMT

Related tags: Blue inspection body, Audit

SGS and blue inspection body sign up to excipact
SGS and blue inspection body sign up to excipact
The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

Excipact – which was launched in January​ – is a certification scheme for people that inspect excipient suppliers and manufacturing facilities​ that is designed to let pharmaceutical excipient users focus their inspection activities more effectively.

The Excipact Association – which was set up by the IPEC Federation – told in-pharmatechnologist.com the training provided to SGS and blue inspection body auditors will give them the skills, knowledge of excipients, GMP, GDP and drugs to properly assess suppliers.

“Users of excipients which have been audited by Excipact registered auditors will then know that the auditor has been thoroughly trained in their needs and the needs of the regulators.

SGS and blue inspection body are the first services firms to have signed up to Excipact, but the Association said: “We are in discussion with other Certification Bodies. We will announce any agreements in due course.

Audit burden

The rationale behind Excipact is that a certification system ensuring the quality of audits will enable excipient users – including drugmakers – to comply with regulatory requirements in the most cost effective way possible.

“There is an expectation that all suppliers are physically audited,” the Association said, adding “this is impossible even given limited resources available to the excipient user because the suppliers could never host that many audits.”

To that end – under current regulatory guidance – it is recommended that drugmakers perform risk assessment to identify non-critical excipients, which is where Excipact comes in.

“The non-critical ones would not require them to perform the audit, but they could then rely on the Excipact scheme for that purpose. By having an Excipact Certificate and audit report available they can demonstrate compliance to the regulations and we then have a win-win situation.” 

The approach – which sees compliant suppliers issued with an Excipact certificate for three years – is supported by both the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products regulatory agency (MHRA).

Related news

Related products

show more

Microaerobic Fermentation of Lactobacillus acidophilus

Microaerobic Fermentation of Lactobacillus acidophilus

Eppendorf for Bioprocess – Solutions that grow with you | 01-Oct-2019 | Application Note

We successfully performed microaerobic fermenta¬tion of a probiotic strain, Lactobacillus acidophilus, at a very low oxygen level, representing the natural...

Removing Aggregates of an Acidic Monoclonal Antibody

Removing Aggregates of an Acidic Monoclonal Antibody

Bio-Rad Laboratories | 22-Oct-2018 | Technical / White Paper

CHT Ceramic Hydroxyapatite Media/Resins are known as the industry gold standard for
impurity removal during monoclonal antibody (mAb) purification....

Single-Step Influenza and Dengue Virus Purification

Single-Step Influenza and Dengue Virus Purification

Bio-Rad Laboratories | 08-Oct-2018 | Application Note

CHT XT is the newest addition to the CHT family of media. It has been designed for superior physical robustness to ensure it can be used repeatedly over...

Related suppliers

Follow us

Products

View more

Webinars