Manufacturer Standards

Q: What is ISO 9001?

A: ISO 9001 defines the criteria for a Quality Management System and is the only standard in the family that can be audited against the goal of voluntary compliance or to become 3rd party registered. There are over one million companies and organizations in over 170 countries certified to ISO 9001. All the requirements of ISO 9001 are generic and are intended to apply to any organization, regardless of its type or size, or the products and services it provides.

Complying with ISO 9001 ensures customers get consistent, good quality products and services, which in turn brings many business benefits.

The standards provide guidance and tools for companies and organizations who want to make sure their products and services consistently meet customer’s requirements and that quality and customer satisfaction are consistently improved.

Q: What is GMP?

A: GMP is an acronym for Good Manufacturing Practices, which requires systematic and standardized procedures in the areas of institutions, personnel, plant, facility equipment, hygiene, verification, documentation, production management, quality management, product sales and recycling, complaint, and adverse reaction reporting, self-testing, etc. GMP achieves a common purpose by implementing this series of procedures: to prevent mixing between different drugs or their components; to prevent cross-contamination from other drugs or other substances; To prevent errors and measurement transmission and information transmission distortion; To prevent accidents that miss any living and inspection steps; To prevent any operation and non-compliance with standards and low-limit inputs and other illegal accidents.

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