Wisdom quality control (QC) team ensure our products and services meet the customers' specific requirements and characteristics.
Strictly follow the ICH guidelines, we exam and test the quality of the whole process of our products and services using the state-of-art instrument and labs.
The QC team provide the reliable data to the quality assurance (QA) team for the release of materials and actions.
Our QC laboratories equipped with 6 platforms:
- Basic impurity/solvent residues research
(NMR(Bruker 300 MHz), HPLC (with VWD/DAD/CAD/ELSD), GCs (with Headspace), Dionex ICS 5000+, UHPLC Ultimate 3000)
- Mutagenic impurities research
(TripleTOF(ABSciex 5600), GCMS/MS(Shimadzu TQ8040), GCMS(Shimadzu), LCMS(Shimadzu), Dionex ICS 5000+/2000+
(Malvern Mastersizer, Olympus CX31)
- Elemental impurities research
(ICP-MS, Microwave Digestion System, Dionex ICS 5000+)
(Class A bench for Positive Testing, Class A bench for Micro Testing)
We are equipped with Data Integrity System (Labsolution CS+). All computers are validated and OOS/OOT/deviation investigation system are well in place.
Our QC Laboratories are staffed by a team of highly trained and skilled chemists.
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
* 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.