Process validationEffective process validation contributes significantly to assuring drug quality. Process validation involves a series of activities taking place over the lifecycle of the product and process. This process validation can be described in three stages:
- Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
- Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
- Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Cleaning validationCleaning validation plays a crucial role to verify the effectiveness of cleaning procedures and ensure no risks are associated with cross contamination which harms the patient safety.
Cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.
Computerized system validationComputerised systems should comply with the requirements of EU GMP Annex 11 and be validated for their intended purpose. This requires an understanding of the computerized system's function within a process. For this reason, the acceptance of vendor-supplied validation data in isolation of system configuration and intended use is not acceptable. In isolation from the intended process or end-user IT infrastructure, vendor testing is likely to be limited to functional verification only, and may not fulfill the requirements for performance qualification.
Media Fill TestWe help pharmaceutical companies conduct MFT in accordance with GMP requirements and best practices. To do this, we help to conduct a risk assessment for intervention. Particular attention is paid to interventions and critical operations (for example, the loading of a sterile substance, the loading of products to a freeze-drier). After analyzing the risks, we develop the MFT protocol, consulting during MFT and check the report.
Sterilization validationOne of the most popular methods of sterilization of medical devices is through exposure to Ethylene Oxide gas (EtO/EO). The gas is an alkaline agent that infiltrates packaged medical devices to kill microorganisms and thus achieve sterilization. EtO is toxic and flammable/explosive at low temperatures (flash point of -20°C) and so is used on products that could get damaged or cannot withstand high temperature processes.