Quality Assurance

At Hit Chemics our company culture is based on quality, spanning across all departments. We are committed to delivering quality experiences for our customers which go beyond the final product.

Our experienced QA team are responsible for supervising the quality and performance of all business and manufacturing processes. We have an innovative embedded quality management system and perform regular internal audits. We look to continuously adapt processes to the requirements of the market and ensure consistent compliance at all stages of the supply chain. Special attention is given to compliance issues, in particular to API manufacturing, testing and handling, change control requirements, method and process validation, controlled substance handling and proper documentation. Our in-house Qualified Person (QP) is able to certify batch release on products from our Swiss GMP site.

Our Certifications and Licenses

We hold several quality certifications and licenses, which are applicable to different sites and services from our portfolio.

These include:

• ISO 9001:2015
• ISO 14001:2015
• ISO 144644
• cGMP compliant plants in Geneva for Chemicals
• PDMA
• CFDA
• License to manufacture, store, ship and sell controlled substances

Regulatory Assistance

Hit Chemics provides outstanding complex chemistry manufacturing services, from small scale custom synthesis to large scale bulk manufacture and for GMP products. For all our custom manufacturing customers, we work as your partner, with a dedicated account manager to ensure effective communication and peace of mind during the entire project lifecycle.

Whether working to ISO 9001 or to GMP, compliance to the latest regulations that apply for your product is essential. Our experienced quality team work with you to ensure you get the quality standard and documentation that you need.  GMP regulations apply across the entire cGMP service, from manufacturing, QC, filling, packaging and warehousing. We are experienced with the development and validation of many API processes that have been through various stages of regulatory approval and are proud to have an excellent inspection record.

Our team works with our customers to meet their quality and regulatory needs and are pleased to be able to offer regulatory filing assistance. Whether for preparation or review, we are experienced in working in the eCTD format.