Assuming that a production batch of oral powder sachets was prepared using a dry mixing method. Post-preparation, a uniformity test for API was conducted, and the results were Satisfactory. Subsequently, the product was filled into sachets using a sachet filling machine. A content uniformity test was then performed, yielding non-conforming results. The root cause was…
What are Good Manufacturing Practices (GMP) and why are they important? GMP refers to a set of guidelines and regulations aimed at ensuring the quality and safety of products throughout the manufacturing process. They are important as they help maintain product consistency, minimize risks, and protect consumer health. How do GMP regulations differ from industry…
Steam sterilization and water shower sterilization are both methods used to sterilize equipment and materials, particularly in pharmaceutical manufacturing. Here’s a comparison between the two: Steam Sterilization – Process: Uses saturated steam under pressure to kill microorganisms. The steam penetrates the materials and transfers heat energy, which causes the coagulation of proteins, effectively killing…
Water has great importance in pharmaceutical industries as it is used for all washing activities & is also used for various manufacturing processes. It is a common observation that pharmaceutical water is distributed through a closed-loop system & this water remains in continuous circulation 24 hours a day & 7 days a week. …
Nature of Pyrogens Pyrogen (fever-inducing agent), principally known as bacterial endotoxin, is one of the most potent bacterial toxins. Its only source is Gram (-) bacteria (GNB), where endotoxin comprises about 75% of the GNB cell wall. Bacterial contamination (bioburden) in water and on surfaces normally contains GNB, so endotoxin is ubiquitous in…
Cleaning validation is a critical process in ensuring that manufacturing equipment and facilities meet stringent cleanliness standards, particularly in industries like pharmaceuticals, biotechnology, and food production. It is essential to demonstrate that cleaning procedures effectively remove residues of active ingredients, excipients, cleaning agents, and microbial contaminants to acceptable levels. This validation process includes establishing…
Formulation design is crucial to ensure that our products meet quality expectations. By applying QbD principles, we can systematically understand the relationship between critical formulation factors and their impact on Critical Quality Attributes (CQAs). Key elements to consider: 1. Quality Target Product Profile (QTPP): Defines the desired quality characteristics of the final product. 2….
This is one of the most stunning microbiological tests. CCA (Chromogenic Coliform Agar) is a selective and differential medium used primarily for the simultaneous detection and enumeration of Escherichia coli and coliform bacteria in water, food, and environmental samples. Here’s the principle behind CCA: Principle of Chromogenic Coliform Agar (CCA) Selective Components – CCA…
As a QA personnel I have some nightmares like: -How many filing cabinets will require to keep every batch record organized in order to manufacture your products? -Are there numerous papers that require review? -Are any documents missing? Many people view maintaining paper records as a necessary evil. The benefits of switching to digital…
