PTI - international

• Comply with current FDA regulatory requirements to avoid enforcement action

• Design and implement a GMP-compliant environment to prepare your firm for an FDA inspection

• Apply proven strategies for identifying and handling GMP deviations and failures and rebound from previous mistakes 

• Define roles and responsibilities to ensure everyone performs efficiently and effectively

• Meet all challenges associated with GMPs by analyzing warehousing, materials, GMP training, labeling, packaging, environment and various manufacturing, laboratory, production and in-process controls

• Compile a quality system checklist to increase efficiency

• Author, manage and maintain SOPs to achieve a solid backbone for your documentation system

• Determine GMP validation requirements and maintain compliance

• Identify current regulatory enforcement trends and avoid common FDA trigger points

GMPs
White Paper
download