The final approval of an outsourcing provider should be dependent on both the written approval of the sponsor company's facility
management and its quality assurance (QA) department. It is not sufficient for management to approve a provider without the
approval of QA, and QA cannot solely approve a provider. It is usual to manage this process under the remit of a department
concerned with the management and approval of providers. The provider should then be formally listed on a register of approved
Following the Audit: The Technical and Quality Agreement
Before commencement of any service provision, a technical or quality agreement should be in place covering the services provided.4
In the US, this agreement is not required but is expected; in Europe, the agreement is mandatory. This technical or quality
agreement must detail the service provided, quality requirements, and the responsibilities attributed to the contract giver
and the contract acceptor. The agreement should be reviewed at a defined interval. This may be done following routine re-assessment
of the provider.
All approved service providers are required to be reviewed and re-approved at regular intervals.4 It is advantageous for sponsor companies to develop a formal program of re-approval that includes all providers, from the
minor to the critical. As a part of this routine process, all approved outsourcing providers can be re-assessed at a predefined
interval to ensure continued compliance with regulatory requirements and the agreements that are in place. Annual auditing
is the usual practice, although a longer interval may be acceptable if justified. Re-assessments will usually entail a re-audit
following the standard process outlined above and a re-approval to confirm the approval status or, if necessary, to remove
the providers from the approved list.
An important consideration here is the change control process mandated by cGMP regulations. If a re-assessment audit shows
a provider's performance to be unsatisfactory, then a formal risk assessment must be conducted to assess the impact on any
product manufactured since the last audit and, ultimately, to assess the safety of the product and patient.
In between the established dates for re-approval, it is important for sponsor companies to continuously monitor the performance
of providers. If the provider's performance begins to falter, the provider's approved status may need to be re-assessed ahead
of the established schedule. Examples could be failure to supply a starting material that meets pre-defined specifications
or to meet established deadlines. A well-maintained history of performance will allow trend analysis and the potential to
stop problems before they become critical.
Regulatory requirements demand that outsourcing providers be part of a system that approves them as fit for purpose. The process
of provider selection and approval must be part of the formal quality management system.
Andy McCallum is a quality assurance manager for Tepnel Research Products and Services' pharmaceutical outsourcing division, Livingston,
UK, +44 (0)1506 424270,
1. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007, MHRA, Pharmaceutical Press, London: 2007.
2. US Food and Drug Administration. Guidance for industry. CGMP in manufacturing, processing, packing, or holding of drugs;
cGMP for finished pharmaceuticals. Rockville, MD; 2006.
3. PIC/S Secretariat. Pharmaceutical Inspection Cooperation Scheme. (See publications/recommendations.) http://
4. Medicines & Healthcare Products Regulatory Agency. Guidance on good manufacturing practices, Part 1: Basic requirements
for medicinal products. In: Rules and Guidance for Pharmaceutical Manufacturers and Distributors. London: Pharmaceutical Press;
2007. p 80–81.