This time we focus on a drug manufacturing facility in South Korea, issued a Warning Letter on June 12, 2024 Inadequate Validation of Manufacturing Processes The facility failed to adequately validate manufacturing processes for their over-the-counter (OTC) drug product. This includes insufficient data to demonstrate process validation and equipment qualification. Corrective Actions –…
Description of the problem: Corrosion and irregularity in the edges of the tablets . Reasons: 1: fine powder. 2: The punches are worn out. 3: The moisture of the powder is low. 4: Hardness is low. 5: The distribution of powder is uneven . 6: Separating the powder in the hopper or while using…
This problem is most often caused by an error in the parameter or setting of the machine reasons for this problem. 1. Inappropriate pan speed, too high or too low. Solution: Work at a pan speed appropriate to the shape ot tablets. 2. The solution was not prepared and dissolved properly. Solution: Prepare…
Type B Type D Read also: Points to be Considered When Purchasing Tablet Punches and Dies Tablet Tooling in Pharmaceutical Industry Resource Person: Ali Saleh Ali
What is the description of the problem? The presence of pits and irregularities at the top of the tablets surface due to the increased porosity of the tablets surface and the penetration of the coating solution into it. What are the reasons? Are the reasons related only to the coating stage or are there…
With more and more washing of the pan and the use of cleaning materials and drying and also with the old age and too much using the machine, the stainless steel of the pan is affected and may interact with the tablets . Now some brands of coating machines have begun to fix this problem…
Critical Process Parameters (CPP), Critical Quality Attributes (CQA) & It’s Stages 1) Wet Granulation 2) Drying 3) Milling 4) Mixing 5) Compression 6) Coating Read also:
Headspace oxygen levels in pharmaceutical products are critical to ensure product stability and safety. Regulatory guidelines provide specific limits and recommendations for controlling headspace oxygen to maintain product efficacy and quality. Here’s an overview based on industry standards and pharmacopeial guidelines: Importance of Controlling Headspace Oxygen: 1. Product Stability: Oxygen can degrade active pharmaceutical…
