IKSA offers a professional service for the planning, execution and reporting of supplier, CMO and general service provider audits in the pharmaceutical and health care sectors.
Globalisation continues to add complexity to the pharmaceutical supply chain. Health authorities increasingly emphasise the need for tighter control and oversight, often driven by direct experience of suppliers and contractors operating below acceptable compliance levels.
A well planned, risk-based approach to managing third parties is essential to ensure the security and safety of the supply chain, as well as meeting expectations of authorities.
Efficiency and Quality
On-site audits are an essential tool in supply chain management and many organisations face the challenge of adequately resourcing an extensive and demanding audit programme to meet current GMP requirements, as well as maintaining budgetary control. Critical success factors include not only an efficient approach to selecting the appropriate audit targets, but also making effective use of limited on-site audit time. Experienced and knowledgeable auditors can ensure that quality-relevant risks can be quickly identified so that appropriate mitigation strategies can be put in place.
What IKSA offers
IKSA has extensive experience in planning, coordinating, executing and reporting of all types of third party audits within the pharmaceutical and general health care sectors. We employ a team of highly experienced auditors including former British, Dutch and German Health Authority Inspectors, with worldwide exposure to EU, FDA, WHO, PIC, Chinese and Japanese standards of GMP.
Many auditors also have a significant industrial background.
With a network of auditors throughout the world, we are able to provide professionals with local experience and knowledge often involving reduced travel times and expense.
IKSA offers any or all of the following services, which can be tailored to individual customer requirements:
- Development of risk-based audit programmes for suppliers, contractors and service providers
- Planning individual audits or entire audit programmes
- Coordination of audits directly with auditee
- Identification and supply of necessary SMEs for specialised audit situations (e.g. IT systems, pharmacovigilance, data integrity reviews)
- Management of travel and logistics
- Participation as either lead auditor and/or support auditor
- Audit reporting
- Development and training of in-house auditors in theoretical and practical auditing skills.