On and Off Site Support for Outsourcing Needs

Summary

Agenda1 were selected by a major pharmaceutical company, who were under regulatory pressure to reassess over 250 raw material analytical methods. A close affiliation between the client and Agenda1 began to form slowly, with care taken to understand the client’s requirements. Working closely with the client, Agenda1 have written and carried out Validation Protocols, and are now well in  into a 2.5 year program. The methods are tested on site with Agenda1 using their wide range of in house equipment, and newly purchased pieces some of which were acquired from the client.

In addition, to support for the method validation work, the client also required additional staff on site, those staff were provided through Recruitment and Temporary staffing division of Agenda1, Agenda1 STaR.

Background

The client is an established manufacturing site of a major pharmaceutical company manufacturing key API’s. They have a wide range of raw materials and methods including GC, Karl Fisher and titration that they use during their production work. GMP standards are met at all times but the reappraisal of the methods was a regulatory requirement.

Due to the high workloads created by the reappraisal, the client decided they also needed an additional team of analysts on their premises to assist them with the laboratory analysis of their API’s. The client had been made aware of Agenda1’s Scientific Training and Recruitment (STaR) division of Agenda 1 and having built the relationship with the Analytical team, they asked the STaR team to provide the additional staff. The STaR team provide both temporary and permanent members of staff that are outsourced to the client by providing potential staff members with a series of online tests that would determine the right person was selected for the position.

Resources

A feature of the close working relationship was the sharing of resources. Both Agenda1 and the client have a wide range of in house equipment available, however Agenda1 purchased significant equipment from the client to support the programme. In addition, training resources were shared, and the client irregularly arranged for their staff to work directly with the Agenda 1 team.

Applications

The client sent a number of methods to Agenda1 which we read and then produced a protocol to assess the method. The protocol was then implemented with the results and our view reported on the method as per protocol.

Amongst the techniques for which Validation Protocols were written and followed were:

GC

KF

Loss on Drying

Titration

Residue on evaporation

FTIR

Results

The client had asked for the help of Agenda1 for two separate tasks, the validation work and extra staff members.

Validation Protocols were written for methods and once the validation tests were complete, ­reports were sent back to the client in an agreed format. The work here was of particular importance as it was a regulatory requirement helping maintain the GMP status of the site.

Three members of staff were successfully provided to site through Agenda1 STaR, some of which were offered full time contracts.

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