Commissioning, Qualification and Validation
Ensuring that your utilities, process equipment and production lines consistently function and operate as intended to produce materials of the desired quality requires a multi-stage process. The three main activities that accomplish this are:
These three activities, often grouped together and termed ‘CQV’, are usually performed in sequence. Commissioning is required before undertaking qualification activities, and qualification of equipment must be completed prior to validation activities.
Regulators frequently update guidelines to ensure that manufacturing facilities operate according to the latest industry standards. Establishing and maintaining an effective CQV process is critical to getting your products to market. Current best practice involves the integration of quality risk management as part of Good Engineering Practice.
MH Chemtech can provide you with a full range of CQV services based on the latest guidelines, including ICH Q9 (Quality Risk Management) and ICH Q7 (GMP for APIs).
Commissioning
Commissioning consists of commercial testing and is carried out to prove and document that an item of equipment or system is safe, functional and ready to qualify. Commissioning without qualification can only be performed on equipment or systems that do not have a direct impact on product quality, or generate data used to release or reject a batch of product. Otherwise, qualification will need to be carried out after successful completion of commissioning.
Qualification
Qualification is the process of proving and documenting that any equipment, utility or system works correctly and within established limits and tolerances. Qualifications are generally smaller in scope and a subset of a larger, more involved validation initiative e.g. Installation Qualification, Operational Qualification and Performance Qualification.
Validation
Validation is the process of establishing documented evidence that a process or method can consistently produce a product (or result or function) to a user specified quality. The concept of validation includes all activities necessary to have a validated process or system e.g. Computer System Validation, Process Validation, Cleaning Validation.