FDA GMP Audits to QSR 21 CFR Part 820 for Medical Device Companies

The US Food and Drug Administration (FDA) requires manufacturers to implement quality systems in accordance with the Quality System Regulation (QSR 21 CFR Part 820), also known as Good Manufacturing Practice (GMP). Manufacturers, specification developers, contract manufacturers and even some distributors must implement a quality system compliant with the QSR.

Medical device manufacturers must conduct FDA GMP audits of their quality management systems in accordance with the Quality System Regulation (QSR). Failure to conduct an internal GMP audit can result in product quality issues, lack of process improvements, or regulatory problems. Emergo Group can perform independent FDA GMP compliance audits on behalf of clients to determine quality system compliance, particularly for clients lacking the resources or experience to perform their own audits.

Elements of Emergo Group's FDA GMP auditing services include:

Gap analysis audit – Through this audit we will determine your current level of compliance with FDA regulation 21 CFR Part 820. The gap analysis can be conducted at any time on the quality system to identify deficient areas.
Full or partial internal GMP audit – FDA regulations require manufacturers to conduct regular internal audits of their GMP quality management systems. Emergo Group provides internal GMP auditing services which allow for an independent review of your full quality system. We can also conduct specific QSR process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred, or focus on areas where conflicts of interest make it necessary to have an outside, independent GMP audit desirable.
Supplier audit - As part of your full or partial GMP audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper manufacturing processes even if you rely on subcontractors for components of your manufacturing operation. We can conduct supplier audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.
FDA pre-inspection audit – We can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. Emergo Group can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA GMP audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator, e.g. complaint handling, corrective action, manufacturing processes, special processes.
FDA QSR mock audit – We can also perform a GMP audit that would mimic an FDA inspection to help the facility prepare for an actual FDA inspection. These type of audits can be done without the knowledge of the entire organization or provided as independent assessment of readiness without company personnel being aware. The FDA QSR mock audits are performed in the manner of a Quality System Inspection Technique (QSIT) inspection to prepare an organization for an actual FDA inspection.