by Dr. Yashashwini Reddy | May 19, 2025
A Site Acceptance Test (SAT) is a critical phase in the commissioning process of equipment or systems. Conducted at the customer’s site after installation, the SAT verifies that the system operates according to specified requirements in its actual operating...
by Dr. Yashashwini Reddy | May 19, 2025
The U.S. Food and Drug Administration (FDA) has issued multiple warning letters to pharmaceutical and medical device manufacturers for deficiencies in cleaning validation processes. These letters highlight the critical importance of robust cleaning procedures to...
by Dr. Yashashwini Reddy | May 19, 2025
What Is Revalidation? Revalidation involves repeating the original validation effort or a portion of it to confirm that a process, system, or equipment remains in a state of control. This process is essential when changes occur that could impact product quality or...
by Dr. Yashashwini Reddy | May 19, 2025
Selecting the appropriate swab for cleaning validation is crucial to ensure accurate and reliable results, particularly in industries like pharmaceuticals, biotechnology, and food processing. An unsuitable swab can compromise the entire validation process by...
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here is a detailed Standard Operating Procedure (SOP) for the Leak Test of Strip, Blister, and Alu-Alu Blister Sealing used in pharmaceutical packaging operations. To define the procedure for performing the...
