Current Good Manufacturing Practices (cGMP) Compliance Set-Up Services
At InterlinkIQ, we recognize that establishing a robust compliance framework is essential for pharmaceutical companies to ensure product safety, quality, and regulatory adherence. Our cGMP Compliance Set-Up Services provide a comprehensive solution to help you implement effective practices and systems from the ground up.
Initial Consultation and Needs Assessment
- Conduct a thorough assessment of your current manufacturing operations and regulatory requirements.
- Identify specific compliance needs based on your product portfolio and market.
Development of cGMP Framework
- Create a customized cGMP compliance framework tailored to your organization’s unique requirements.
- Outline essential components such as quality management systems, standard operating procedures (SOPs), and documentation practices.
Standard Operating Procedures (SOPs) Creation
- Develop and document SOPs for all critical manufacturing processes, ensuring they meet regulatory standards.
- Ensure clarity and usability of SOPs to facilitate training and compliance.
Training and Capacity Building
- Provide comprehensive training sessions for staff at all levels on cGMP principles and best practices.
- Equip your team with the knowledge and skills necessary to maintain compliance effectively.
Quality Management System (QMS) Implementation
- Design and implement a robust Quality Management System that encompasses all aspects of cGMP.
- Include risk management practices and continuous improvement methodologies.
Documentation and Record Management Setup
- Establish a documentation control system to manage and maintain essential records.
- Implement processes for efficient data capture, storage, and retrieval to ensure compliance.
Internal Audit Preparation
- Prepare your organization for internal audits by developing checklists and criteria tailored to your operations.
- Conduct mock audits to identify potential areas of concern and ensure readiness for regulatory inspections.
Supplier and Vendor Qualification
- Assist in the qualification and monitoring of suppliers and vendors to ensure compliance with cGMP standards.
- Develop criteria and processes for evaluating supplier performance and quality assurance.
Ongoing Compliance Monitoring and Support
- Offer continuous support to ensure sustained compliance through regular check-ins and updates.
- Monitor regulatory changes and provide guidance on necessary adjustments to your compliance framework.
Final Compliance Review and Certification
- Conduct a comprehensive review of your cGMP set-up to ensure all elements are functioning effectively.
- Provide a certification of compliance readiness to support your regulatory submissions.