cGMP
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Regulatory Support
current Good Manufacturing Practice
Strict compliance with cGMP and
FDA Guidelines Guarantees Quality Products.
cGMP manufacturing facilities, procedures, and documentation are maintained in accordance with current Good Manufacturing Practice as described in the United States Code of Federal Regulations and ICH Guidance Q7 for Active Pharmaceutical Ingredients.
Production Control Systems
- QA controlled documentation system
- Raw materials handling system (Receiving, testing, labeling and release)
- Environmental monitoring of the clean room
- Microbiological monitoring USP purified water system
- Specific task training
- In-process control testing, verification of critical steps (i.e., Ninhydrin, LC-MS and HPLC)
Oct 2002 State of California - Drug Manufacturing License No. 42162