Guidance and Policy
OC is responsible for policy development and outreach including training and internal and external presentations to industry. A primary focus area of this responsibility is in developing cGMPs guidance and policy, and revising and developing cGMPs regulations. The guidance and regulations created by these activities provide the standard for industry compliance. In addition, OC provides technical input on cGMPs and coordinates program activities between CDER and the ORA, particularly in drafting the Compliance Policy Guidance for field investigators for drug manufacturing inspections and in identifying areas of concern in the drug industry.
OC also helps to prepare proposals to help protect consumers, provides technical and regulatory input for international and domestic cGMP cases, provides technical input on inspectional program guides and training, participates in CDER program coordinating committees and manages special assignments, including inspectional work plans.
