GMP Pharmaceutical Compliance Auditing

Last year, FDA investigators issued almost 700 Form 483s to drug manufacturing facilities. Experienced QA auditors could have identified those issues before the FDA did. Not only does an inadequate audit program leave you vulnerable to regulatory enforcement action, but it is, itself, often cited as a violation.

You don’t have to jeopardize your business or your status with regulatory bodies. And you don’t have to worry that you’re unknowingly out of compliance with CGMP regulations. We can help you. Our auditors’ in-depth knowledge of domestic and international regulations, and their hands-on CGMP experience, can take the uncertainty out of GMP compliance.

Facility Audits

• Inspect facilities, equipment, and laboratories
• Review all pertinent documents that support GMP and client specifications
• Assess Quality Manangement Systems, including all internal SOPs and associated CGMP documents
• 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

Vendor GMP Audits

• Perform routine and qualification audits of contract facilities used for manufacturing, packaging and labeling, and distribution
• Perform routine and qualification audits of contract laboratories and suppliers of drug substance (APIs), raw materials (excipient), and packaging components
• Inspect facilities and equipment
• Assess qualification and training of personnel
• Review organization structure and SOP content
• Assess Quality Systems and CGMP compliance

GMP Clinical Trial Materials

• 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 for regulatory inspections
• Assess readiness of site personnel for Pre-approval inspections by FDA or other regulatory agencies
• Prepare personnel for inspector interviews
• 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 components, such as internal SOPs, specifications, change control, trend analysis, input inspection, outsourced operations control, and personnel development
• 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 GMP compliance. Contact Polaris today.