Auditee: Ensuring that our products meet FDA requirements for identity, strength, quality, and purity is a fundamental aspect of our operations. Here’s an overview of how we ensure compliance with these requirements:
Identity
- Raw Material Verification: All incoming raw materials are rigorously tested and verified to confirm their identity, using validated analytical methods and reference standards.
- Product Labeling: Product labels accurately represent the identity of the product, including its name, active ingredients, strength, dosage form, and any relevant identifiers.
- Batch Records: Detailed batch records document the specific raw materials used, their sources, and the manufacturing processes to ensure traceability and confirm identity.
Strength
- Formulation Consistency: Our manufacturing processes are optimized and controlled to ensure consistent formulation, accurately delivering the intended strength of active ingredients.
- In-Process Testing: During production, in-process testing is performed at critical stages to verify that the product is meeting the specified strength requirements.
- Finished Product Testing: Finished products undergo rigorous testing to confirm that their strength matches the specifications outlined in approved documents.
Quality
- Quality Management System: Our Quality Management System (QMS) is designed to ensure that quality is built into every aspect of our operations, from development to manufacturing.
- Standard Operating Procedures (SOPs): Detailed SOPs outline the processes, methods, and criteria for quality control activities to ensure consistency and compliance.
- Internal Audits: Regular internal audits assess our processes, systems, and facilities to identify areas for improvement and ensure adherence to quality standards.
Purity
- Raw Material Testing: Raw materials are thoroughly tested for impurities, contaminants, and adulterants to ensure they meet established purity standards.
- Quality Control Testing: Finished products undergo comprehensive testing to detect any impurities or contaminants that may impact the product’s purity.
- Stability Testing: Products are subjected to stability studies to monitor their purity over time and ensure they maintain their intended quality throughout their shelf life.
Through these comprehensive measures, we ensure that our products consistently meet FDA requirements for identity, strength, quality, and purity. By maintaining rigorous quality control practices and adhering to regulatory guidelines, we uphold the safety, effectiveness, and reliability of our pharmaceutical products.