Compliance &
Certifications
Maintaining the highest standards of regulatory compliance across all pharmaceutical operations. Our comprehensive certification portfolio ensures patient safety, product quality, and regulatory adherence at every level.
Registered
Licensed
Compliant
Certified
Comprehensive Compliance Framework
SGP Care operates under a robust compliance framework that exceeds industry standards and regulatory requirements. Our commitment to compliance ensures the highest levels of safety, quality, and regulatory adherence across all operations.
Regulatory Excellence
Our comprehensive compliance program encompasses all aspects of pharmaceutical operations, from manufacturing and distribution to clinical research and patient care. We maintain continuous compliance monitoring and proactive regulatory updates to ensure we exceed all requirements.
Proactive Compliance Monitoring
Real-time monitoring systems ensure continuous adherence to all regulatory requirements
Regular Certification Updates
Ongoing renewal and enhancement of all certifications and licenses
Expert Compliance Team
Dedicated regulatory affairs professionals with extensive industry experience
Compliance Rate
Monitoring
State Licenses
FDA Citations
Core Certifications & Licenses
Our comprehensive certification portfolio demonstrates our commitment to the highest standards of pharmaceutical operations and regulatory compliance.
FDA Registered
503B Outsourcing Facility
Registration #: FDA-2024-SGP-001
DEA Licensed
Schedule II-V Controlled Substances
License #: DEA-SGP-2024-001
DSCSA Compliant
Drug Supply Chain Security Act
Full Traceability Implementation
ISO Certified
ISO 9001:2015 & ISO 13485:2016
Quality Management Systems
FDA Registration Details
DEA Licensing Portfolio
Standards & Guidelines Adherence
SGP Care adheres to the most stringent pharmaceutical standards and guidelines, ensuring consistent quality and safety across all operations.
cGMP Standards
Current Good Manufacturing Practice compliance ensuring consistent production quality and safety standards.
- 21 CFR Parts 210 & 211 Compliance
- ICH Q7 API Manufacturing Guidelines
- Process Validation Protocols
- Equipment Qualification (IQ/OQ/PQ)
USP Guidelines
United States Pharmacopeia standards for pharmaceutical compounding and quality assurance.
- USP 797 Sterile Compounding
- USP 795 Non-Sterile Compounding
- USP 800 Hazardous Drug Handling
- USP 1163 Quality Assurance
DSCSA Implementation
Complete Drug Supply Chain Security Act compliance with enhanced traceability and verification.
- Electronic Product Identification
- Transaction History Documentation
- Product Verification Systems
- Suspicious Product Investigation
Additional Standards Compliance
International Standards
- ICH Guidelines (Q7, Q8, Q9, Q10, Q11)
- WHO Good Manufacturing Practices
- PIC/S Good Manufacturing Practice Guide
- European Medicines Agency Guidelines
Quality Management
- ISO 9001:2015 Quality Management
- ISO 13485:2016 Medical Devices
- ISO 14001:2015 Environmental Management
- OHSAS 18001 Occupational Health & Safety
Quality Management Systems
Our comprehensive quality management framework ensures consistent excellence across all pharmaceutical operations and continuous improvement in all processes.
Integrated Quality Framework
Our quality management system integrates all aspects of pharmaceutical operations, from raw material procurement through final product distribution, ensuring consistent quality and regulatory compliance.
Process Control Systems
Real-time monitoring and control of all manufacturing processes
Continuous Improvement
Data-driven approach to process optimization and quality enhancement
Document Control
Comprehensive documentation management and version control
Quality Control
- Advanced Analytical Testing
- Microbiological Testing
- Environmental Monitoring
- Sterility Assurance
- Certificate of Analysis
Quality Assurance
- Batch Record Review
- Product Release Testing
- Deviation Investigation
- CAPA Implementation
- Risk Assessment
Regulatory Affairs
- Regulatory Submissions
- Inspection Readiness
- Change Control
- Global Compliance
- Training Programs
Documentation & Record Management
Comprehensive documentation management system ensuring complete traceability, regulatory compliance, and data integrity across all operations.
Document Control System
Our advanced document management system ensures all regulatory documentation is current, accessible, and compliant with 21 CFR Part 11 requirements for electronic records and signatures.
Standard Operating Procedures (SOPs)
Comprehensive SOPs covering all aspects of pharmaceutical operations:
- Manufacturing and Compounding Procedures
- Quality Control and Testing Protocols
- Environmental Monitoring Procedures
- Equipment Maintenance and Calibration
- Document Control and Record Keeping
Batch Manufacturing Records
Complete documentation for every batch produced:
- Raw Material Specifications and Testing
- Manufacturing Process Parameters
- In-Process Testing Results
- Final Product Testing and Release
- Distribution and Traceability Records
Regulatory Submissions
Complete regulatory documentation portfolio:
- FDA Registration and Renewal Documentation
- DEA License Applications and Renewals
- State Licensing Documentation
- DSCSA Compliance Documentation
- Inspection Response and CAPA Plans
21 CFR Part 11 Compliance
Our electronic document management system fully complies with FDA regulations for electronic records and signatures:
- Secure Electronic Signatures
- Complete Audit Trails
- Access Control and Authentication
- Long-term Record Retention
- Data Integrity Assurance
Document Retention Policy
Audit & Inspection Excellence
Our outstanding inspection history demonstrates our commitment to maintaining the highest standards of compliance and operational excellence.
Inspection Timeline
March 2024 - FDA Inspection
Comprehensive facility inspection - Zero observations, zero deficiencies
Result: ExcellentNovember 2023 - DEA Audit
Controlled substances security and record keeping audit
Result: No violationsAugust 2023 - State Board Inspection
Multi-state pharmacy board compliance inspection
Result: Full complianceMay 2023 - ISO Surveillance Audit
Annual ISO 9001:2015 quality management system audit
Result: Certificate maintainedInspection Readiness Program
Our comprehensive inspection readiness program ensures we maintain audit-ready status at all times:
- Monthly internal audits
- Regular mock inspections
- Continuous compliance monitoring
- Staff training and certification
- Real-time corrective actions
FDA Citations
Inspection Pass Rate
Request Compliance Documentation
Need specific compliance documentation or have questions about our certifications? Contact our regulatory affairs team.
Regulatory Affairs Contact
Available Documentation
- FDA Registration Certificates
- DEA License Documentation
- ISO Certification Portfolios
- DSCSA Compliance Attestation
- Quality Management System Documentation
- Inspection History Reports