Production in both the pharmaceutical & cosmetic industries has to be done according to very strict regulations and quality management systems (e.g. Pharmacopeia, ISO 22716). Having GMP (Good manufacturing practices) in place is important to gain clients, built up a reputation, and support the growth of your entity.
This includes prescriptions for the product process, facilities, personnel, training, documentation, validation but also assuring product hygiene and clean environments. You might say that GMP is designed to minimize the risks involved in any production process that cannot be eliminated through testing the final product. It is mandatory to have this.
Manufacturing facilities must maintain a clean and hygienic manufacturing area, including laboratories and storage. Monitoring this clean environment is of the utmost importance. This includes water (WFI), air (HVAC) and all surfaces that can influence the quality and safety of the final product.
To safeguard the clean environment the design, validation and implementation of a documented and approved cleaning and disinfection programme must form a key part of any production area qualification.
A range of different factors needs to be considered in the selection of disinfection products used. Some of these factors include the mode of action, efficacy, compatibility and cost. Also, these disinfection products have to be in line with current health and safety standards.