Selecting a GMP Cleaning Service Provider-Part Two
Updated: May 10
Determining the needs and requirements of a service provider begin with determining the criticality of the product being manufactured. The critical nature of the materials being used and manufactured will be used to define the risk level of activity being performed and the responsibilities of the cleaning service provider servicing the facility.
High Risk activities will have the highest levels of quality required to successfully manufacture the product. Pharmaceutical manufacturing, contract manufacturing and active ingredient for pharmaceuticals will fall into this category. Examples of high risk activities would be: drug products, active pharmaceutical ingredients, excipients for parenteral products, medical devices or any materials sourced from high risk locations that is part of the supply chain.
Medium Risk activities are still subject to regulatory requirements. Excipients and primary packaging would be considered medium risk. Examples of medium risk activities would include: registered starting materials, primary packaging, non-sterile excipients and regulated printed packaging.
Low Risk activities are less dependent on stringent process controls, but performing due diligence will assure success for a manufacturing firm. Low risk examples include: secondary packaging, tertiary and other packaging and other raw materials such as solvents and commodities used in the manufacturing process.
Understanding the risk levels of the manufacturing process will determine the level of cleaning that is required for each process. Often times within a facility, multiple processes are being performed each with a differing level of cleaning and different SOPs. Nx2 has successfully engineered countless cleaning programs that are custom tailored to each facility and each customer. From high risk to low risk, each process is integral in the overall success of a manufacturing firm. Our wide customer base as well as years of experience allow us to draw from a bank of knowledge that is endlessly helpful to our customers.
Training of service workers and competency in performing cleaning tasks as well as documentation are of paramount importance when it comes to validation as well as auditing. Nx2's proven track record is evidence of our ability to recruit, train, monitor and validate our service workers and the work they perform. Using both technology as well as time-proven training techniques allows us to perform the tasks that allow customers to focus on their operations.