PROBLEM STATEMENT
Client 1 and 2: Two different consulting companies needed a consultant to conduct a retrospective review of major and critical change controls, deviation investigations, and OOS investigations to identify the gaps in investigations and change controls as a part of FDA commitments.
EXPERTISE AND SOLUTIONS
Two different client companies hired a PJI Biotech principal consultant to support the retrospective review of investigations, OOS, and change control projects. The team reviewed deviation investigations and OOS to ensure that the root cause and impact analysis were adequate. All the associated CAPA were reviewed to ensure that CAPA was effective, and gaps were identified. The client company was provided with the summary of identified gaps and recommendations to improve the investigation and OOS processes/procedures and strengthen associated training programs.
In addition, a retrospective review of change controls was conducted to ensure compendial changes were implemented and to identify any potential gaps. The team reviewed the change controls for accuracy, completeness, and timeliness of implementation. The identified gaps and recommendations were presented to the client.
RESULTS
As a result, the client was able to meet their objectives related to the FDA commitments.