Quality is an important aspect of virtually any product, in any market, and in any industry. In pharmaceutical and related industries, ingredient integrity must be assured and proper dosage maintained to assure quality. Deviations can lead to serious ill-health effects that may be introduced by poorly or inadequately designed production processes. It is the responsibility of the manufacturer to assure the proper level of quality is guaranteed in a product.

Process validation is the experimental design and work that is carried out to prove or assure that key product quality parameters are met under the processing conditions and limits outlined for the production process. Validation requirements will vary with industry and application; however, every phase of pharmaceutical production must be validated including Wurster fluid bed coating steps.

Coating Place is prepared to perform process validations for any product produced. The validation process begins by identifying the key product and process parameters. Once these are identified, a batch record is finalized to outline the production parameters and a validation protocol is written to define the requirements of the validation. The validation likely includes assessments of applicable production parameter ranges, assay or release uniformity, residual solvent verification, or particle size distribution. Once work outlined in the protocol has been performed, acceptable results have been generated, and the final report written, the production procedure is validated for production.

Coating Place has the staff and resources to perform every aspect of a process validation including generation of a process validation protocol, execution of validation batches, generation of analytical data under GMP guidelines, and generation of a process validation final report.