Good Manufacturing Practices (GMP)

Solstice Medicine adheres strictly to Good Manufacturing Practices as defined by the U.S. Food and Drug Administration (FDA). These include:

• Meeting or exceeding requirements for the evaluation and qualification of manufacturing facilities
• Initial vetting and ongoing monitoring of facility performance and reputation
• Verifying FDA facility registration, committing our partners to Agency inspections for adherence to good manufacturing practices

We work closely with brand owners and manufacturers to clearly define responsibilities across manufacturing, distribution, and consumer usage to reduce any potential confusion or errors. Our manufacturing partners must always use appropriate packaging components and configurations.

Product Classification and Labeling

To ensure compliance with U.S. regulations, we:

• Categorize and classify products specifically for U.S. market labeling requirements
• Coordinate with brands to prepare labeling that complies with product category regulations

Herb Sourcing and Raw Material Selection

Solstice Medicine only works with trusted growers and suppliers who adhere to sustainable and ethical practices. We are heavily involved in these partner relationships.

Our collaborations entail:

• Ensuring optimal growing regions for each herb
• Verifying proper cultivation methods are used
• Confirming herbs are harvested at optimal times
• Overseeing appropriate post-harvest handling

Coordination ensures proper herbal product testing and certification, verifying the correct species, optimal maturity, and overall quality before any herb can be used in our products.

Quality Control and Product Testing

We work continuously to enhance our Chinese medicine quality assurance processes. Some of these quality control practices involve:

• Verifying the identity and quality of herbs before they enter the manufacturing process
• Checking for contaminants before, during, and after manufacturing
• Ensuring active compounds are present in appropriate quantities

In-House Quality Control

We handle the final laboratory testing to verify that finished herbal products meet specifications after they arrive in the United States. Products undergo a series of examinations before they are approved for use, such as:

• Visual inspections for authenticity
• Organoleptic evaluations (appearance, smell, taste)
• Moisture analysis
• Detailed compound identification

For specific details about our current testing protocols, please contact our team.

Quality Assurance Throughout Distribution

Our measures for quality control in Chinese herbal medicine extend beyond manufacturing:

• Consumer Support: Through social media, phone, email, fax, and mail, we offer U.S. consumers a direct point of contact for product inquiries, suggestions, and serious adverse event reports.
• Social Responsibility: We uphold social responsibility by providing U.S. consumers with a clear, open line of communication with brand owners and manufacturers.
• Regulatory Compliance: We manage commercial lot inventories to fulfill regulatory tracking and tracing requirements at every stage of distribution.

Pharmacopeia Guidelines

Solstice Medicine adheres to multiple pharmacopeia guidelines to meet international standards. We comply with, and often exceed, requirements established by United States Pharmacopeia (USP). These guidelines include:

• Methods for extraction, concentration, and purification
• Mandatory tests for foreign organic matter and microbes
• Facility and equipment standards
• Test methods for ensuring bioavailability of formulas

We also regularly review our adherence to other respected pharmacopeias, such as the Chinese Pharmacopoeia and the European Pharmacopoeia. A global perspective helps us maintain a comprehensive approach to quality assurance.