Current Good Manufacturing Practices

CGMP are the Current Good Manufacturing Practices followed by the 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 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.