Quality at Wisdom

Wisdom Quality Assurance team participate, monitor, and manage the whole process of operations to develop and produce active pharmaceutical ingredients according to the high-quality standards defined by the current Good Manufacturing Practices, and the International Convention for Harmonization (ICH) Q7/Q8/Q9/Q10/Q11 guidelines.

To provide service to the worldwide regulated pharmaceutical markets, Wisdom has been frequently audited and qualified by global leading pharmaceutical companies and certified by FDA, EDQM, PMDA, SFDA, and MOA. The latest successful FDA inspection was in March 2018.

* Management standard and qualification certificates

Our cGMP quality management system is stablished upom FDA requirements, ICH, 21CFR and Chinese GMP.

* Quality system procedures

Oranizitional Chart

* Quality management

1. Documentation Management
The documentation room is used to archive all the original GMP files, batch production records, batch analysis record and validation files. Adedicated person is assiagned to manage the documentation room and ensure the safty, confidentiality and traceability of all documents.
Photo (retaining room)

2. Stability study and retention
QA is responsible to do the stability study of related products, especially the APIs and key intermediates. Sample of every batch is reserved for the later investigation.
Photo (retaining room)

Wisdom regulatory department is responsible for communication with the regulatory authorities. We ensure the compliance with the latest regulatory requirements. We apply the latest regulation to our cGMP system.

 

Our regulatory team participates in the project management from the very beginning. We consider and include all regulatory elements in the project development, quality research, manufacturing, and preparation of documents.

 

We are experienced in DMF submission in CTD format or the country-specific requirement. We also support our customers for regulatory submission.