HPCUS: Homeopathic Pharmacopoeia Convention of the United States

Homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by the FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). If you are exporting homeopathic drugs into the United States, your monograph must be approved by the HPCUS Monograph Review Committee (MRC).

The Pharmacopoeia Revision Committee will also review this monograph.  After review, the MRC may return the submission to the sponsor for more data or clarification, reject the monograph, or accept the monograph.  Once the monograph is approved by the MRC and PRC, the HPCUS will implement the new homeopathic drug.  Once implemented by the HPCUS, it is approved by the FDA.

Current Good Manufacturing Practices

CGMP are the Current Good Manufacturing Practices followed by pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity.

Running a national or global pharmaceutical company is a stressful job in the best of times without the additional pressure of keeping up with ever-changing industry regulations.

We offer a number of pharmaceutical consulting services, each designed to help you assure CGMP compliance including CGMP compliance assessments, document assistance including editing or developing your quality system documents, regulatory submission assistance, CGMP training, review of facility plans with a CGMP perspective, and other CGMP-related activities for manufacturing, distribution, laboratory operations, and regulatory action assistance.

Although there are a number of GMP guidelines, all guidelines follow a few basic principles.

• GMP Documentation
• GMP Training Records
• GMP Compliance
• GMP Manufacturing
• GMP Validation

Technical translations for the pharmaceutical industry

– Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs, to prevent recurrence.

Let the TechLink International consulting team assist you in seeking strategic solutions, rather than simply outlining lists of problems. Contact us today for more information on our FDA consulting services.