GMP audit services for pharma

Your strategic partner in supplier qualification

✓ 500+ audits ✓ qualified GMP auditors ✓ worldwide coverage

Logo Novartis audit
Logo Pfizer audit
Logo Mallinckrodt audit
Logo Roche audit
Logo MSD Merck Sharp Dohme audit
Logo GSK GlaxoSmithKline audit
For pharma and biotech

How can we help?

How can we make your supplier qualification easy?

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.

Our GMP audit experience

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.

Who we can audit

GMP audit services

  1. GMP contract manufacturers (CMO's)

  2. API and excipient suppliers

  3. Pharma distributors and warehousing

  4. Contract laboratories

  5. You, if you like

  6. Other service providers

  1. GMP audit preparation

  2. GMP audit execution

  3. GMP audit reporting

  4. CAPA definition

  5. CAPA review

  6. CAPA implementation

Recent GMP audits

we do not sell GMP audit reports.

Axicorp pharma logo

PCS performed an external GMP audit of AxiCorp, the Netherlands.

Wacker biotech logo

For an American biotech organization, PCS audited Wacker Biotech (Amsterdam) on GMP.

Logo Cryoreliance pharma storage

Cryoreliance was audited by PCS for an American biotech company.

Logo Syneos Health pharma Australia

PCS performed a remote GMP audit of Syneos Health in Australia.

Initial supplier audit

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.

GMP audit process

  1. Agree on audit date(s)
  2. Exchange and mutually execute an NDA
  3. Exchange of documents (SMF, SOP on SOP, etc.)
  4. Audit preparation
  5. Audit execution
  6. Audit report, including CAPA's

For an overview of a regular GMP audit click this link..

How much does it cost?

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
Initial supplier qualification - GMP audit - average pricing ex. related costs

Supplier qualification program

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.

GMP supplier qualification experience

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.

How much does it cost?

Costs depend on the scope of services, general pricing can be found under "Initial supplier audits".

How can we help?

Get in touch by sending us a message

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