Pharmaceutical Compliance Associates
Pharmaceutical Compliance Associates (PCA) specializes in compliance consultation relating to current Good Manufacturing Practice (GMP) regulations and Food & Drug Administration (FDA) requirements. Services offered by PCA include compliance audits and mock FDA inspections, establishment and implementation of quality assurance programs, development and review of validation studies, investigation and resolution of compliance and quality problems, compliance review of facilities and equipment design, and development and presentation of employee training programs.
PCA’s consultation and training services are conducted by professionals with extensive compliance experience including prior employment with the FDA.
GMP Consulting Services
On-Site GMP Training
- Good Manufacturing Practices (GMPs)
- Clinical Supplies and Research & Development
- Part 11
- FDA Inspections
- CGMP: Interpretation and Application
- Batch Record Review and Investigations
- GMP Compliance Auditing
- GMP Compliance and Auditing for Sterile Pharmaceuticals
- GMP Compliance for Quality Control Laboratory Operations
- Validation and Qualification Compliance Requirements
Validation
- Design Validation Studies
- Review Validation Study Protocols, Data & Reports
Facilities
- Review Facilities and Equipment Design for Compliance with GMP and FDA Requirements
FDA Compliance
- Response to FDA Letters & FDA-483’s
- Response to FDA Regulatory Actions
- Correction of FDA Observations
- Representation at FDA Meetings
Compliance & Technical Audits
- Internal GMP Audits
- Mock FDA Inspections
- Pre-approval Inspections (PAI) Audits
- Contractor Audits
- Audit Program Development
- GMP Compliance Evaluation
- Research and Development Compliance Programs
Quality Assurance
- Change Control System
- Quality Assurance Programs
- Document Control System
- Product Annual Review Program
- GMP & Technical Training Programs
- Batch Record Review System
- Process Deviation Investigations
- Product Failure Investigations
- Batch Release/Rejection Evaluation