FDA GMP Quality System Audits

Internal Quality System audits are mandatory by the FDA

The QS regulation requires that planned and periodic audits of the quality system shall be performed to verify compliance with the quality system requirements. The audits are to be performed in accordance with written procedures by appropriately trained individuals who do not have direct responsibility for the matters being audited. Audit results shall be documented in written audit reports, which shall be reviewed by management personnel, who have responsibility for the matters audited, and by other involved parties.

To assure that company quality goals will be routinely met and to comply with the QS regulation, quality system audits should:

• measure the effectiveness of the quality system
• provide objective evidence that adequate controls are in place
• assure that products and processes conform with specifications

All manufacturers should have a written quality audit procedure, although the details will vary with the manufacturer size and nature of the manufacturing operations. An audit procedure should include:

• an objective
• audit scope
• an audit schedule
• assignment of responsibilities
• evaluation criteria
• management review of results
• corrective action policies, schedules, etc.

Non-compliant products will lead to poor quality and loss of certification. Audits take time and expertise. TechLink International experienced staff will assist you to:

• establish quality systems that are adequate for producing devices that consistently meet the device master record requirements,
• establish system requirements that will continue to function when new products are introduced, changes are made, the workforce is understaffed.

If you are located in North America, Europe or Japan, you can apply for quality management system auditing services from TechLink International:

Gap analysis audits

Want to know how compliant your devices are in accordance with the appropriate quality regulations such as FDA GMP, ISO 13485, Japan PAL and/or CMDR? This is for you. The gap analysis allows you to pinpoint which areas are deficient.

Pre-assessment Audits

TechLink International recommends that such an audit be conducted at least several weeks prior to a certification audit. Want to know all areas of non-compliance and what to do about them before your certification audit?

Full or Partial Internal Audits

Regular Internal Audits of the Quality Management System must be undertaken by manufacturers according to ISO and FDA QSR (21 CFR Part 820). At TechLink International, we have what it takes to provide independent internal auditing services so that you can assess your quality system. We also provide such services on a contract basis if you prefer a partial audit which allows us to concentrate on specific areas of the quality system you believe may be non-compliant. It may also be that your audit services cannot provide you with such services for various reasons including conflicting interest. In all instances, call us, we will help you!

Subcontractors and Supplier Audits

When your devices are manufactured by a subcontractor, you have to make sure that the manufacturing process complies with the relevant regulations. This is your responsibility while it is also often compulsory to do so. You can delegate TechLink International to take on the task of conducting an ON-Site Supplier Audit to be sure that your specifications are being followed to the letter according to regulations.