What external standards or benchmarks will the company use to measure its quality, and how will it seek to achieve compliance with these standards?

In the life science and pharma industries, there are several external standards and benchmarks that a company can use to measure its quality. One of the most commonly used standards is the Good Manufacturing Practices (GMP) guidelines set forth by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These guidelines establish minimum requirements for the design, control, and operation of manufacturing facilities and processes in order to ensure the safety and efficacy of pharmaceutical products.

Achieving compliance with GMP guidelines is essential for any company operating in the life science and pharma industries. To do so, the company will need to implement a robust quality management system that is designed to meet the requirements of the GMP guidelines. This system should include processes for ensuring that raw materials, intermediates, and finished products are manufactured and tested in accordance with GMP requirements. It should also include procedures for addressing any quality issues that may arise during the manufacturing process.

In addition to GMP guidelines, there are other external standards and benchmarks that a company in the life science and pharma industries may need to comply with, depending on the specific products it is manufacturing. Additionally, companies that are manufacturing biologic products may need to meet the standards set forth by the International Organization for Standardization (ISO), which provides a framework for quality management systems in the life science and pharma industries.

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