@jauhar123 | Posted 12 Jun. 2019
Did you understand that pharmaceutical cleaning validation is a significant and time-consuming portion of the manufacturing process? It is designed to guarantee that companies adhere to Good Manufacturing Practices (GMP) and Quality Systems Regulations (QSR). In layman’s terms, validation is a documented guarantee that cleaning can be performed certainly and repeatedly.
Pharmaceutical cleaning validation trade has been a topic of ever-increasing importance and scrutiny in the current Food and Drug Administration (FDA) inspections. The validation of procedures utilized to clean the equipment employed during the various steps of a manufacturing method is a definite requirement of current Good Manufacturing Practice (cGMP). As such, FDA inspectors now expect to notice a functioning cleansing validation program with appropriate documentation in place during their inspections.
The requirement that equipment is clean before moving practice is not an innovative concept. The uniformly essential requirement that it also be sanitary is many times obfuscated by the word, neat.
In reply to the frequently-asked question “what is clean,” the FDA published a supervision document: the 2004 FDA “Guide to Inspections Validation of Cleaning Processes.”
The FDA’s lead to inspections, which “intended to include equipment washing for chemical residues only,” includes:
“FDA expects firms to have written methods [Standard Operating Procedures (SOPs)] listing the cleaning processes...”
“FDA expects firms to have written extensive procedures on how cleaning processes will be validated.”
These systems will “address who is liable for performing and approving the validation study, the acceptance criteria, and when revalidation will be wanted.”
“FDA expects firms to direct the validation studies in accordance with the protocols and to document the results of studies.”
Besides assuring chemical cleanliness, “the microbiological features of equipment cleaning should be viewed. This consists largely of preventive measures…”
“Determine the specificity and subtlety of the analytical method utilized to detect residuals or contaminants.”
“The firm should challenge the analytical method in combination with the sampling method(s) used to show that contaminants can be recovered from the equipment outside and at what level...”
“Direct sampling (e.g., with swabs) is ‘most desirable,’ although rinse sampling may be satisfactory.”
Once it has been authenticated that the method can be repeated to remove residues below to tolerable levels, a program will want to be implemented so that the time of validation can be maintained. Changing any part of the method (such as the cleaner responsible) actually mandates revalidation. This involves developing previously validated steps until the current method has also been validated.
The objectives of this article are to establish a comprehensive source for cleaning validation in pharmaceutical industry policy and programs and to determine the requirements, acceptance limits, procedures, and working papers wanted to support this vitally important activity.
Because cleaning validation is achieved when it is impractical to verify hygiene on 100% of the production equipment used in high-volume manufacturing, the industry relies on these methods. These critical cleaning steps can transform the quality or the safety of the final product, which is why it is so essential that they are done correctly.