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….
The BCS categorizes drug substances into four BCS classes as follows: What is High Solubility? The highest dose strength of the drug can be dissolved in ≤ 250 mL of aqueous media at a pH from 1 to 6.8 (including pH = pKa, pH = pKa + 1 and pH = pKa-1) and a temperature of 37 °C ± 1 °C. What is High Permeability? The fraction…
GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are both quality assurance systems that are crucial in the pharmaceutical manufacturing industry. While they share some similarities, there are also notable differences between the two concepts. Standards: 1. GMP: GMP focuses on ensuring that pharmaceutical products are consistently produced and controlled according to quality…
USP <711> contains a couple references to pooled sampling for dissolution. What is pooled sampling and when is it appropriate? What risks are there with pooled sampling? Pooled sampling is a procedure where each sample from a dissolution time point is combined into a single sample. Pooled sampling is only done for immediate-release dosage…
