7 Keys To Establishing A Quality Culture Your Senior Management Will Love

By Christine Park, Quality Architech

Executive Management participation and support is key to the successful development, implementation, and management of pharmaceutical quality systems. The FDA guidance document (Quality Systems Approach to Pharmaceutical CGMP Regulations) defines the expectations for management with executive responsibility (MWER).  These expectations for MWER are aligned with the Q10 Guideline, published by International Conference for Harmonization (ICH). 

Bottom line:  Executive management has the responsibility and authority to assure compliance to the quality system and appropriate regulations for your product. MWER are those individuals who have ultimate responsibility for the quality of the product, as well as providing overall support and management of the business. These are usually the most senior executives in the organization. One of the most important responsibilities and activities to drive compliance is to develop and support a strong quality culture within the organization!