Compliance to cGMP is a vital part of the manufacturing process within the pharmaceutical and medical device industry, each process step in manufacturing of a product is subject to quality-inspection, to ensure the end products are safe and effective, every time.
Pharmaceutical
We offer both quality control inspections and validation engineering services for all incoming materials, finished goods, process validation (OQ, PQ, PPQ), including equipment/system validations (FAT, RTM, URS, SAT, IQ, OQ-E) and test methods development and validation.
Our services includes:
Incoming quality inspection
First article inspection (FAI)
Tensile Testing
Compression Testing
Writing of master validation plan
Writing of protocols
Execution of the plan/protocol
Organizing data from the study
Analyzing the data
Reporting the analysis of the study results
Justification to deviation and corrective action plan
Ensuring accuracy of record retention