Cleaning validation is a critical aspect of quality control, and ensuring your product is fit for release. We can support you with cleaning validation, both for due diligence and troubleshooting issues.
Cleaning validation is key to the manufacturing process. It is vital for you to ensure that your cleaning processes remove active pharmaceutical ingredient residues, cleaning materials, and any microbial contamination to a pre-determined level, to avoid waste from a previously manufactured product compromising the quality of the subsequent product. This is a GMP requirement that will be fully inspected by the relevant regulatory authorities.
Our team conducts expert analysis of swabs, purge and rinse waters to support you with cleaning validation and due diligence, and reflect the expectation of current GMP guidelines.
We use a number of detection techniques that may be coupled to chromatographic analysis. Mass spectrometry may also be necessitated to achieve greater sensitivity for particularly low detection limits.
We also provide consultancy and training to support your cleaning validation processes. Our practical one-day Cleaning Validation training course provides professionals responsible for the design, execution and validation of cleaning processes with a thorough grounding in process design and pitfalls to avoid, along with understanding of fundamental issues in the area.
We can help with:-
- Validation of cleaning procedures
- Microbiological and chemical analyses of swabs, rinses etc
- Chemical analysis
- Interpretation of the results
- Development of and validation of analytical methods for cleaning validation
- Process improvement
- Cleaning validation training
- To ensure the safety and purity of your products
- To meet regulatory requirements for API product manufacture
- To help you assure the quality of your process
- Enable your teams to be fully trained