Coating Place has the staff and resources to perform every aspect of process validation for your product.
Process validation involves the experimental design and work performed to assure that key product quality parameters are consistently met under the processing conditions and limits outlined for the production process. This is particularly crucial for pharmaceutical products where ingredient integrity must be ensured and proper dosage maintained to guarantee safety and efficacy.
Coating Place process validation begins by identifying the key product and process parameters. Once these are identified, a batch record is created to outline the production parameters and a validation protocol is written to define the requirements of the validation.
A typical process validation will include assessments of the following:
· Production parameter ranges
· Assay or release uniformity
· Residual solvent verification
· Particle size distribution
Once the work outlined in the protocol has been performed and acceptable results have been achieved, a final validation report is compiled.
Coating Place has the staff and resources to perform every aspect of process validation including the following:
· Developing the process validation protocol
· Executing validation batches
· Generating analytical data under GMP guidelines
· Writing the final process validation report