QUALITY SYSTEM (Part 820 cGMP)
Implementation-Ready Quality System
For Your Company
Smith Associates has developed implementation-ready Part 820 Quality Systems which includes SOPs with supporting logs and forms. The QS Part 820 is priced reasonably to meet quality system requirements from start-ups in the design phase to the small or large company, with Class I, II or III products. The SOPS, forms, WIs and Quality Manual have been reviewed by the FDA during inspections all over the United States and internationally, and will assist you in maintaining a stable and compliant FDA 820 cGMP System.
Quality System Audits
The FDA requires regularly schedules internal audits. An adjunct to this schedule is a third party inspection
The outside audit puts new and objective eyes on your system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and documented change to your SOPs. From our experience, a good many of the 483s occur when the SOPS and the actual procedure do not match.
Our objective is to identify those non-conformances that may occur by omission or commission and assist your company in correcting any anomalies.
483 Observations & Warning Letter Responses
How serious is a 483 Observation?
It is serious since the inadequacy of your response can lead to further FDA actions including a Warning Letter. The object of careful response is to avoid that escalation of review.
I have received 483 Observations after my FDA inspection, how do I know if I am answering them correctly?
A company’s handling of responses to 483 Observations, Warning Letter and Recalls are critical to a company’s survival in the present FDA regulation climate. A company’s response must be timely, and comprehensive. Smith Associates has successfully assisted many companies in their responses to 483 observations to the FDA’s satisfaction.
Recalls and Corrections
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective
Recalls may result from your 483 Observations or from a Warning Letter. Like all responses to the FDA, a Recall must be comprehensive and exhaustive in removing all recalled product from distribution. Smith Associates can provide the assistance to you company for:
- Recall strategy
- Health hazard evaluation
- Coordination with FDA district office
- Stock recovery – degree and depth of recall
- Recall letter
- Public warning
- Recall status reports
- Effectiveness checks