Autoclave Validation Risk: Uneven temperature distribution could lead to incomplete sterilization. QRM Application: Conduct risk assessments for load configurations and identify critical spots for temperature sensors to ensure uniform heat distribution. Cold Chain Validation Risk: Temperature excursions during storage or transport might compromise product quality. QRM Application: Use risk-based mapping to monitor high-risk areas (e.g.,…
When the specifications for the drug substances or drug product are being prepared, The following concepts as per ICH Q6A are important in the development and setting of harmonized specifications. such as, but limited to: 1) Periodic or Skip Testing: Periodic or skip testing is the performance of specified tests at release on pre-selected batches…
Here is a comparison of Deionized (DI) water, Reverse Osmosis (RO) water, and Distilled water based on their purification methods, purity levels, and applications: Deionized (DI) Water Purification Process: Purity Level: Applications: Reverse Osmosis (RO) Water Purification Process: Purity Level: Applications: Distilled Water Purification Process: Purity Level: Applications: Key Differences Summary Choosing the Right Water:…
Is there a requirement to run a leak test of lyophilizer after every cycle in GMP pharmaceutical production? GMP regulations do not mandate leak testing after every lyophilization cycle, but periodic testing is required to ensure equipment integrity and product quality. The frequency is determined by risk assessment, internal procedures, and process criticality. 1.1 European…
OAI (Official Action Indicated) classification: the facility is deemed out of compliance with CGMP. OAI regulatory meeting is conducted if FDA have already issued a warning letter. To DISCUSS THE ISSUES WITH THE FIRM BEFORE PURSUING LEGAL ACTION THROUGH THE DEPARTMENT OF JUSTICE. These meetings provide a deeper dive into technical matters that may require…
To make the effervescent reaction happening a carbonate component and an acid are required. In the presence of water, carbon dioxide is formed, and the tablet disintegrates. This leads to the typical bubbling. Effervescent tablets have a separate monograph in the pharmacopoeia which e.g., limits the disintegration time. Typical Excipients Disadvantages of Effervescent Tablets Effervescent…
Wetting agents are surface-active substances which reduce the surface tension of water. By improving the wettability of hydrophobic substances, they increase the dissolution rate of APIs. Liquid and Paste-Like Wetting Agents in Wet GranulationA lot of these standard surface-active substances are liquid or have a paste-like consistency and can therefore only be processed during wet…
Another group of excipients in solid dosage forms are the so-called water penetration enhancers. How They Work They do not have any disintegration effect themselves but assist water to penetrate the tablet. As a result, water can reach the particles of the disintegrants better, and these can therefore develop their effect more quickly. Which means…
