Pharmaceutical Good Manufacturing Practice (GMP) for processes, equipment, facilities, utilities, quality control and quality systems through flexible auditing solutions including shared audits. Intertek is your partner for auditing all of your suppliers, subcontractors, or service providers involved in the pharmaceutical product lifecycle

Comprehensive pharmaceutical supplier and subcontractor audits remain a critical part of the drug development and manufacturing process for evaluating, monitoring, and therefore improving control over quality concerning your supply chain. All regulatory agencies who set standards for the pharmaceutical industry have an expectation of GMP compliance across pharmaceutical manufacturing supply chains. As a consequence, pharmaceutical companies have an obligation to engage with their supply chains, which are increasingly complex involving a multitude of suppliers and subcontractors throughout the production process.

Our audits activity was created over 10 years ago and our expert auditors have evolved our range of auditing solutions to meet the challenges that your business faces today. With a network of more than 130 senior qualified auditors located all around the world, we are proud to support our global clients, enhancing their visibility of their suppliers. Our quality system and our auditor qualification process, driven by our Quality manager, is regularly audited by our clients with positive outcomes of reliability and robustness.

Intertek's flexible solutions include private or individual audits, shared audits, CAPA evaluation and follow-up, audit report purchase, remote audits and support for your internal audit program. We audit suppliers and manufacturers of APIs, excipients, packaging materials and other materials, subcontractors of manufacturing, packaging, analytical testing, service providers of clinical trials (CROs), pharmacovigilance, transporters, IT service, cleaning service and all other services. 

These audits are conducted against the applicable regulatory texts or standards such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice, (GCP), Good pharmacovigilance Practice (GVP). We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufacturing Practices), EFfCI GMP for cosmetic ingredients, ISO 15378 standard for packaging materials, ISO 13485 standard for Medical devices, ISO 9001 standard or EHPM Quality guide for food supplements.

Shared Audits
Our shared audit solution brings the benefits of cost optimisation of your audit program, lower barriers to scheduling audits of your suppliers, personalised reports that respond to your specific questions.

Private Audits
Driving greater transparency of your supplier or subcontractor our private audits are a solution that is ideal for in-depth understanding when Audit for cause, project, or particular context.

CAPA Evaluation and Follow-up
Because the auditor is a good person to evaluate the CAPA plan in response to the audit findings, we propose this service as an additional option to the audit. And to guarantee the audit closure, we can also make the follow-up for you.

Audit Reports Purchase
When obtaining an audit date is difficult on certain sites, to address travel restrictions or in case of emergency, we can provide you with our catalogue of audits already carried out, where it is possible to request and purchase certain audit reports.

Remote Audits
Remote audits are becoming a popular choice to mitigate the challenges posed by travel restrictions. Our global team can provide efficient and comprehensive remote audits for your suppliers worldwide.

Internal Audits
By partnering with Intertek for your internal audit programs, our auditor’s objective approach and the challenges they highlight helps you to drive continuous improvement.

Total Quality Assurance
With over 10 years’ experience over 5 continents, our Intertek team and our auditors have won the continuing trust of more than 700 clients. Bringing quality and safety to life, our team help drive quality and visibility across all areas of production and distribution for raw materials, healthcare and beauty products. Our auditors’ knowledge helps you to identify and mitigate the intrinsic risk in your operations, supply chains and processes.

The pharmaceutical industry continually faces great challenges from increases in health authority inspections, increasingly complex globalised supply networks, and ever-expanding regulatory expectations. We can help you to overcome these challenges through our Total Quality Assurance expertise for shared audit services, delivering consistently, with precision, pace and passion, enabling our customers to power ahead safely.

 
Pharmaceutical Auditing Services:
GMP Auditing
Pharmaceutical Shared Audits
GCP Clinical Auditing
Auditing Services for Cosmetics Subcontractors and Suppliers
Pharmaceutical Auditing for OTC Drugs
Pharmaceutical Inspection
Business Assurance
Pharmaceutical Services:
Intertek Pharmaceutical Services
CMC and GMP Laboratory Services
Biopharmaceutical Development Support Services
cGMP Pharmaceutical Quality Control Testing
Inhalation Drug Product Development Services