Maintaining compliance to 21 CFR 210 and 211 is critical to the pharmaceutical industry. This includes adherence to current good manufacturing practice (cGMP) by understanding and implementing the processes and procedures defined in FDA Guidelines. Companies that require assistance in establishing, maintaining, or improving their quality systems and procedures because of compliance violations can get professional, reliable, and actionable strategies from Regulatory Compliance Associates® Inc. and our network of experienced consultants.
We can assist with answering 483 observations and developing long-term strategies that will help your organization maintain compliance through continuous process and system improvements. Impact analysis and risk assessment activities can include but are not limited to:
- Review and Improvement of Investigations/CAPAs
- Development of Training Modules for Comprehension to Various Parts of the Regulations
- Strategic Review and Assessment of the Organization for Personnel Optimization
- Redesign and Improvement of Laboratory Operations
- Method Transfers and Instrument Qualifications
- Process Validations, Technology transfers
- Review and Assessment of the Effectiveness of the Internal Audit Function
- In-depth System Audits and Recommendations for Improvements
- Site Inspection Readiness Activities and Mock Inspections
- Review and Assessment of Complaints
- Supplier Quality Programs and Quality Agreements
We can help establish, evaluate, and improve your quality systems to help your organizations and suppliers or contract providers maintain compliance to the regulations.