Gap analysis and Action Plan management/implementation

• The company turned to the specific expertise of the S4BT Qualification Team (equipment, environments, and utilities) which oversaw the project in all the following phases:

Gap Analysis, in which the S4BT Team highlighted the level of compliance of the existing qualification documentation with respect to the regulatory provisions and corporate and international standards (cGMP and FDA).

Action Plan. The “Gap analysis” provided the basis for:

• 
  the definition of all the actions to be taken in order to ensure full compliance of equipment and/or plant with company and international standards
• 
  the definition of priorities on the basis of the size and/or severity of the “gaps” found
  

Qualification Master Plan

Once the existing “gaps” and the appropriate activity plan were defined, the project QMP (Qualification Master Plan) was drawn up containing:

• the objectives of the qualification activity
• the responsibilities of the various professionals involved in the project
• the qualification strategy to be adopted
• the inventory of the equipment and/or plant involved in the project
• the list of qualification documentation (eg DQ, IQ, OQ, PQ) to be drawn up for all equipment and/or plant

Action Plan implementation

Once the QMP was approved, the S4BT team was involved in the following activities:

• Action Plan Implementation
• Support in the management and planning of the various qualification activities
• Drafting of qualification documents (DQ, IQ, OQ, PQ)
• Support in the review of qualification documents and SOPs