A GMP Surveillance Model

Monitor/Gather

Scan relevant agency and other websites, including both free and paid subscription sources, at the appropriate frequency for relevant information.   In addition to Internet sources, reports from conferences, personal discussions, interviews, trip reports, and other sources feed into the process. 

Triage

Sort through the data gathered to determine what may be relevant to the organization.  This must be performed by individuals with deep and broad experience in the industry to be effective. Extract what may be relevant for further processing.  Determine relevance based on experience, or on review by an expert in the area.

Analyze

Assess the potential impact of what you have discovered on the company – for example, high, medium, or low impact – to guide the communication steps.  High impact potential examples include changes to sources referenced in quality standards, and FDA Warning Letters, EU NCRs, or FDA import alerts against a supplier or CMO. 

Communicate

The communication method will depend on the potential impact to the business.

High impact potential will be communicated immediately to the affected area(s). Ensure it is received.  For quality standard impact, a formal, documented communication process is recommended.



Archive

Archive such that the data is organized and easily retrievable.  Over time, large amounts of relevant data are being collected and archived – this represents the "C" in CGMP, and can be leveraged to create CFR 211.25 (a) compliant GMP training.  I can show you how to do that.



I can help you build a GMP surveillance process in your company – or help you enhance an existing one.

Quality Knowledge Management


Further leverage the work done to increase quality compliance and add more value to the business by moving to a Quality Knowledge Management (QKM) platform.  Make the information accessible in a single, fully-searchable tool, populated in real time. See QKM page on this site for more information.