Addressing the recent FDA Form 483 issued to a firm has outlined compliance Concern: A Call for Data Integrity and Accountability – A recent FDA Form 483 issued to a firm has outlined several critical observations that highlight significant deficiencies in compliance and quality management systems where DATA INTEGRITY, RESPONSIBILITY, and ACCOUTABILITY are apparently lacking….
DOP/PAO testing is a very quick process that tests the integrity of the HEPA (High Efficiency Particulate Air) filter using DOP or PAO solutions in their operational conditions. These solutions generate a gas type smoke and then generate gas particles that will be greater than .03 microns. The test will certify the HEPA filter is…
Title and Identification:Including the type of test being performed, batch number, sample ID and date of analysis. Procedure Steps:Clearly outlining each step of the test method and procedures along with the references. Raw Data Entry:Areas to record experimental observations, instrument readings and raw data. Additional data prints like spectra should be attached. Calculations:Sections to perform…
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…
