Month: November 2023

Cleaning Validation in Pharmaceutical Industry

Cleaning Validation in Pharmaceutical Industry

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…

Frequency of Sterilization In Place (SIP)

Frequency of Sterilization In Place (SIP)

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…

Interview Questions and Answers on IPQA

Interview Questions and Answers on IPQA

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….

Biopharmaceutics Classification System (BCS)

Biopharmaceutics Classification System (BCS)

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…

Difference Between GMP and GLP
| |

Difference Between GMP and GLP

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…