Quality
Quality control and laboratory
At KCM Pharma every production batch passes through laboratory control. Physicochemical and microbiological analyses run from raw material intake to finished product; stability and packaging compatibility testing is carried out, and a certificate of analysis is issued for each batch.
Incoming raw material control
Every raw material entering the facility is accepted against the supplier's certificate of analysis and identity-checked. Unapproved material does not enter production; batch numbers are entered into the traceability record, so if an issue appears in a finished product the raw material batch used can be traced back.
In-process control
During mixing and homogenisation, critical parameters such as temperature, mixing time and viscosity are monitored and recorded. A sample is taken before filling to check appearance, odour, pH and viscosity. If those values fall outside the target range, filling does not begin.
Finished product analysis
- Physicochemical analysis: pH, viscosity, density, appearance and odour
- Microbiological analysis: total viable count and pathogen screening
- Packaging compatibility testing: monitoring interaction between formula and packaging
- Stability testing: shelf-life verification under accelerated and real-time conditions
- Issuing a certificate of analysis (CoA) per batch
Retention samples
A reference sample is taken from every production batch and stored under appropriate conditions for the shelf life of the product. In the event of a complaint or investigation, assessment can be made on a sample from the same batch as the product in the field.
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