The knowledge gained through appropriately designed development studies culminates in the establishment of a control strategy. As shown in the picture, control strategy could include three levels of controls as follows: Level 1 utilizes automatic engineering control to monitor the CQAs of the output materials in real time. This level of control is the…
pH is a measure of a solution’s acidity or alkalinity. In the pharmaceutical industry, pH is important because it can affect the stability, efficacy, solubility, and bioavailability of drugs: pH is mesured in the pharmaceutical industry to check/ensure: 1. Drug stability The stability of many drugs is affected by pH. For example, some drugs…
A pharmaceutical manufacturing process usually consists of a series of unit operations to produce the desired quality product. Unit operations may be executed in batch mode or in a continuous manufacturing process. A process is generally considered well-understood when: (1) all critical sources of variability are identified and explained (2) variability is managed…
Over the years, QbD’s focus has been on the process design, understanding, and control, as discussed in the ICHQ8 (R2) guidance. It should be emphasized that product design, understanding, and control are equally important. Product design determines whether the product is able to meet patients’ needs, which is confirmed with clinical studies. Product design…
Technology Transfer Protocol An authorized technology transfer document, such as a Master Plan (or Technology Transfer Protocol), should list the intended sequential phases and activities of the transfer, where appropriate. The document should include, for example, the following: Standard Operating Procedures (SOP) Standard operating procedures (SOPs) should be followed describing the actions to be…
Cleaning validation is a process that is gaining more & more attention day by day in the pharma industries. What Is Cleaning? The process of removing residues of previous products from any equipment used for manufacturing/packaging or area. The pharmaceutical products or area can be contaminated by one of the following: What…
The frequency of Sterilization In Place (SIP) in the pharmaceutical industry can vary based on the type of sterilization method being used. Here are some common types of sterilization and their associated frequencies: 1. Steam Sterilization: This is one of the most widely used methods in the pharmaceutical industry. The frequency of SIP for…
What is In process checks? In process checks are checks performed during an activity,In order to monitor and,if necessary, to adjust the process to ensure that product confirms to its specification. What are the check point during line clearance of granulation area? Why granuation is important? To improve powder flow. To improve compressibility….
