Approval Standards

Where Standards Meet Integrity

At CA we aim to surpass all FDA, EPA, AMA, and other governing bodies’ regulations while ensuring efficacy, here’s a comprehensive list of tests you should consider for both products and equipment:

Topical, Oral, Injection, and IV Products

Safety and Toxicology Testing
  • Acute and Chronic Toxicity Tests: Evaluate immediate and long-term toxic effects
  • Sensitization/Allergenicity Tests: Assess potential allergic reactions, especially for topical products.
  • Dermal Irritation and Sensitization (for topical products): Ensure no skin irritation or sensitization.
  • In vitro and in vivo Carcinogenicity Tests: Rule out cancer-causing potential.
  • Mutagenicity/Genotoxicity Tests: Detect potential genetic mutations.
  • Endotoxin and Pyrogen Testing (for injectables and IV products): Ensure no bacterial contamination.
Stability Testing
  • Long-term Stability: Test over extended periods under various conditions (temperature, humidity, light).
  • Accelerated Stability: Short-term testing under extreme conditions to predict shelf life.
Photostability Testing
  • Check how the product reacts to light exposure.
Microbial Testing
  • Total Microbial Count: Verify that microbial contamination is within acceptable limits.
  • Pathogen Testing: Test for harmful pathogens (e.g., E. coli, Staphylococcus aureus, Pseudomonas aeruginosa).
  • Sterility Testing (for injectables and IV products): Ensure the product is sterile.
Efficacy Testing
  • Clinical Trials: Conduct controlled, randomized, and double-blind studies to assess efficacy.
  • Bioavailability Studies (for oral, injection, and IV products): Determine the degree and rate at which active ingredients are absorbed and reach the target tissue.
  • In vitro and in vivo Efficacy Studies: Test the product’s action on cells, tissues, or animal models.
Pharmacokinetic and Pharmacodynamic Testing
  • Absorption, Distribution, Metabolism, and Excretion (ADME): Understand how the product behaves in the body.
  • Dose-response Relationship: Determine the optimal dosage for efficacy.
Compatibility and Impurity Testing
  • Impurity Profiling: Identify and quantify impurities and degradation products.
  • Container Closure Integrity Testing: Ensure the packaging doesn’t contaminate or degrade the product.
  • Heavy Metal Testing: Ensure the absence of harmful heavy metals such as lead, mercury, cadmium, and arsenic.
  • Leachables and Extractables (for IV and injection products): Identify substances that may leach from packaging or syringes into the product.
  • Performance Testing (Topicals): Assess spreadability, absorption rate, viscosity, and sensory characteristics.
Approved Products

Equipment

Electrical Safety Testing
  • IEC 60601-1 Compliance: Verify adherence to the international standard for medical electrical equipment.
  • Electromagnetic Compatibility (EMC) Testing: Ensure equipment doesn’t interfere with other devices or systems.
Mechanical Safety Testing
  • Drop Tests and Shock Resistance: Check durability and resilience to handling and transport.
  • Ingress Protection (IP) Rating: Test against dust and water infiltration.
Biocompatibility Testing (for equipment with skin or body contact)
  • ISO 10993 Compliance: Evaluate any materials that come into contact with the skin, blood, or tissues.
Sterility and Cleanliness (for reusable equipment)
  • Sterilization Validation: Verify that sterilization processes are effective.
  • Microbial Contamination Testing: Ensure that the equipment meets hygiene standards.
Functional Performance Testing
  • Operational Performance Testing: Assess the equipment’s functioning under various conditions.
  • Load Testing: Test the equipment’s capacity under maximum loads to ensure it works effectively and safely.
Environmental Testing
  • Temperature and Humidity Testing: Ensure the equipment performs well under different environmental conditions.
  • Vibration and Shock Testing: Check how the equipment handles transportation and use-related stresses.
Usability Testing
  • Human Factors/Ergonomics Testing: Ensure that equipment design supports safe, effective, and comfortable use.
Radiation Safety Testing (for devices emitting radiation)
  • Ionizing/Non-ionizing Radiation Testing: Ensure that emitted radiation levels are within safe limits.
Software Validation (for equipment with software):
  • Software Verification and Validation: Ensure that any embedded software functions correctly and reliably.
Calibration and Accuracy Testing
  • Calibration Verification: Regularly confirm that the equipment’s measurements are accurate.
Approved Equipment

By performing these tests, we ensure that products and equipment not only meet but surpass all regulatory standards, maintaining the highest possible levels of safety and efficacy for wellness and aesthetic applications.

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