Consultants Specializing in Regulatory Affairs for FDA Compliance

Quality Templates (Part 820 cGMP)

Templates For Small and Large Companies

Design & Development Control Outline

Smith Associates has developed templates for the entire 820 regulation requirements that include SOPS and forms to ensure that your company is in total compliance to cGMP. These Quality Systems have undergone review by the FDA in many audits.

The 510k submission process is increasingly including a manufacturer's readiness to manufacture their device to a Quality System and with additional scrutiny of Design Control in the design and development of your device. 510ks are moving to a mini PMA look. In the PMA process the Quality System is front and center in the approval process and an unsatisfactory Quality System review can mean either a delay to approval or even result in a disapproval.

Design Control has jumped to front and center in factory audits. , which includes the design and development of your product and any changes in product and processes that may occur post-approval. The following chart is an example of the Design Control activities impacting the 510k and PMA/BLA submission and subsequent factory audits. Design Control begins once you move out the concept and feasibility phase and correctly apply with all the checks and balances in place to provide a product that meets the user's needs in terms of safety and efficacy.

Every aspect of Part 820 is addressed from Management Responsibilities to Complaint Handling Procedures, and includes comprehensive SOPS and accompanying forms, logs and work instructions.


Quality System Implementation

An objective review of SOPs and WIs is crucial to ensure that the SOP and WI that is being put in place reflects what is actually happening. A template is guidance but it is through implementation that it takes on a living document within your Quality System. An objective observer can better judge the discrepancies between what is written and what is actually taking place. Smith Associates has implemented many complete Quality Systems and has also integrated important pieces of FDA Part 820 that are only tangentially touched on by ISO Systems.

Once SOPS, Forms, Logs and Work Instructions are in place and the templates are tailored to your product and your product specifications, you will have all documentation in place to ensure that the product that you think you are making IS always the product you are making. But A Quality System is a living document and with the mission statement of adherence to product specifications.

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.

Pre-Audit Preparation for FDA Inspections

A pre-FDA audit can assist your company in preparing for your audit, identify any trouble spots and resolve them before the FDA audit rather than responding to FDA 483 observations after the audit.

Can I have a consultant during an audit?

Yes. Most companies do not realize that they may have a third party representative for their company during an FDA inspection, as an observer and also to assist in the response if any 483 Observation should occur. Smith Associates has represented companies as an on-site consultant during FDA inspections internationally and in the United States. Our resume includes Class III FDA audits for device PMAs, in-vitro diagnostic PMAs and Class I and II FDA audits.

The FDA just called for an inspection next week, but my Quality System is not complete…now what?

And what a feeling that is to be ill prepared for a surprise inspection. We can help you fill in your Quality System gaps or provide an entire QS with our Implementation-Ready Quality System

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