GMP/CGMP Pharmaceutical Compliance Auditing

Facility Audits

• Review facilities for GMP compliance to Federal regulations, International Conference Harmonization (ICH) Guidances and client specifications
• Review all pertinent documents that support GMP and client specifications
• Inspect facilities, equipment and laboratories
• Assess Quality Systems including all internal SOPs and specifications
• Assess CAPA programs (Corrective Action/ Preventive Action)
• Review validation of manufacturing equipment, product process and equipment cleaning
• Assess Vendor Certification Programs
• Review method validation (analytical and microbiological)
• Evaluate data integrity
• Review electronic systems for 21 CFR Part 11 Compliance

Vendor Audits

• Evaluate manufacturing facilities and nonclinical laboratories utilized as contractors for compliance to FDA regulations and guidelines, ICH guidances, Organization for Economic Cooperation and Development (OECD), and client specifications
• Inspect sites utilized as contractors (i.e., manufacturing, packaging and labeling, laboratories, distribution centers) and suppliers of drug substance (APIs), raw materials (excipient) and packaging components
• Review all pertinent documents that support GMP's and clients specifications
• Evaluate data integrity
• Assess compliance of internal SOPs and specifications
• Perform follow-up audits annually or semi-annually

GMP Clinical Trial Materials

• Develop clinical trial materials labeling
• Review labeling for compliance to clinical protocols and the regulations
• Evaluate suppliers of raw materials, packaging and labeling components, and distribution of clinical trial materials

Inspection Readiness / Pre-Approval GMP Inspection Audits

• Evaluate the preparedness of manufacturing facilities, nonclinical laboratories for regulatory inspections
• Assist personnel to prepare for pre-approval inspections and general GMP inspections
• Assess readiness of site personnel for FDA Pre-approval inspections via GMP as per FDA regulations and guidances
• Compare Chemistry, Manufacturing and Control (CMC) submissions against supportive documentation
• Assess technical transfer for manufacturing and test methods
• Review submitted method validations

GMP Quality Systems

• Assess Quality Systems, including internal SOPs and specifications
• Assess CAPA programs

GMP Validation

• Review method validations (analytical and microbiological)
• Review validation of manufacturing equipment, product process and equipment cleaning

Each day your Good Manufacturing Practice compliance goes unconfirmed, you jeopardize both your business and your status with the FDA. Don’t continue to worry about your pharmaceutical compliance.  Instead, contact Polaris  today. Our consultants’ in-depth knowledge of the regulations and their hands-on CGMP experience and regulatory compliance knowledge can take the guess work out of GMP compliance.