Cleaning procedures are essential for preventing the contamination of manufacturing products. Those procedures must be well-documented, approved, and consistently performed by professionals to ensure the quality and safety of a product. Cleaning validation ensures that the facility and equipment are designed, used, and maintained in a manner that will remove by-products, cleaning agent residues, or microorganisms from new products.
In the pharmaceutical industry, regulators expect to see a validation program with documented evidence that a process will consistently lead to a product that meets quality standards. In other words, the compliance, quality, and safety of drug products depend upon a cleaning validation program. Read on to learn more about the importance of a validation program in pharmaceutical manufacturing.
Prioritizing Pharmaceutical Quality Assurance
It’s important to identify potential contaminants that could compromise the safety and efficacy of drug products. A cleaning validation program allows manufacturers to eliminate the possibility of contamination before developing a drug. In particular, these procedures are important whenever there is a change in manufacturing that could impact the potential for residue on surfaces.
Cleaning validation is required whenever there is:
- New equipment
- New processes
- A change in raw material composition
- A change in a cleaning method or cleaning agent
- A change in a utility system e.g. water
Any changes in the manufacturing facility have the potential to affect the end product. On the other hand, if the equipment is disposable or only used on a specific product, cleaning validation procedures are not essential. Those in pharmaceutical quality assurance roles are responsible for monitoring the changes in a production facility and performing validation procedures when necessary.
Compliance With Industry Regulations
An adequate cleaning validation program is essential for ensuring that a manufacturing facility remains compliant with pharmaceutical regulations. It is a global regulatory requirement to have a cleaning validation program that will ensure the identity, safety, purity, and quality of a manufactured drug. Knowing the essential elements of a compliant quality system is crucial for employment in the pharmaceutical industry.
Students in a pharmaceutical certification program will understand the importance of compliance when it comes to the control of pharmaceutical products as well as the consequences of inaction. In some cases, a manufacturing site can be shut down if it’s lacking a sufficient cleaning validation program in place. In other cases, failing to comply with these regulations can result in costly delays in production and the need for a remedial validation program.
What Should a Cleaning Validation Process Include?
Professionals should take a systematic approach to cleaning validation to ensure consistency and reliability. Developing an effective program involves designing the cleaning procedures, evaluating the procedures to ensure they are reproducible, and ongoing monitoring to ensure they remain effective. At the same time, it requires documented evidence that covers the different stages of the validation program.
Evidence should include:
- The corporate cleaning validation policy
- Cleaning validation plan
- Cleaning procedures used for each product
- Operator training
- Review program for monitoring each cleaning process
With a clearly documented validation program, pharmaceutical companies can maximize the efficiency, quality, and safety of their facilities.
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