We take care of the preparation, execution and reporting of your GMP audits.
With qualified GMP auditors on every continent, we can deploy GMP auditors and subject matter experts on short notice, wherever they are needed.
PCS performed over 500 audits since 2000. Including GDP, GCP and GLP audits.
For Sandoz and Novartis PCS executed the fully supplier qualification audit program.
Novartis and Sun Pharma have contracted PCS to qualify their global auditors.
GMP contract manufacturers (CMO's)
API and excipient suppliers
Pharma distributors and warehousing
You, if you like
Other service providers
GMP audit preparation
GMP audit execution
GMP audit reporting
PCS performed an external GMP audit of AxiCorp, the Netherlands.
For an American biotech organization, PCS audited Wacker Biotech (Amsterdam) on GMP.
Cryoreliance was audited by PCS for an American biotech company.
PCS performed a remote GMP audit of Syneos Health in Australia.
If you have a new supplier you want to know they're right for the job.
Our GMP audits mainly focus on GMP compliance. But we're often asked to include metrics that measure adequacy of resources, how modern the equipment is and how non-GMP data is handled.
Most initial supplier audits can be completed in one day by a PCS certified GMP auditor.
For an overview of a regular GMP audit click this link..
Average pricing can be found in the table below. The actual cost depends on a number of factors such as number of days, product complexity and travel costs.
|# of audit days||Europe||North-America||South-America||Asia||Middle-East||Africa|
|1||$ 4350||$ 5050||$ 2640||$ 2880||$ 2880||$ 4500|
|2||$ 5925||$ 6860||$ 3645||$ 3965||$ 3965||$ 6125|
Outsourced supplier qualification made easy. Cost-effective solutions for small to medium sized enterprises. Including risk-based prioritization.
PCS takes care of the entire process, we perform risk ranking to decide which supplier is first, and which supplier comes last. From initial auditee contact to CAPA follow-up.
We performed the supplier qualification audits for Novartis and Sandoz (amongst others), we set-up the supplier qualification program for Norgine International and qualified the global auditor group of SUNpharma.
Costs depend on the scope of services, general pricing can be found under "Initial supplier audits".