1. Key Parts of 21 CFR Relevant to CSV 21 CFR Part 11: Key aspects include: 21 CFR Part 820: 21 CFR Part 211: 2. Applying 21 CFR in CSV Planning Phase System Requirements Definition: Risk Assessment: Validation Activities Validation Plan: Design Qualification (DQ): Installation Qualification (IQ): Operational Qualification (OQ): Performance Qualification (PQ): Documentation and…
Persistent Challenges in Tablet Production If sticking or overlubrication is a permanent problem during tablet production, a useful alternative can be the external lubrication of the punches and dies. It is a standard add-on for modern rotary tablet presses. How Does External Lubrication Work? A nozzle sprays dry lubricant just before the feeder onto punches…
Nitrosamines are potential carcinogens that can form in drug products through different pathways. Regulatory authorities such as the USFDA, EMA, and WHO mandate a thorough risk assessment to identify, mitigate, and control nitrosamine impurities in products. Key Steps in Nitrosamine Risk Assessment: Identify Potential Risk Factors: Evaluate Potential Pathways of Formation: Perform Analytical Testing: Risk…
Pharmaceutical microbiology plays a critical role in ensuring the quality and safety of pharmaceutical products. Microorganisms can contaminate products, potentially harming patients and compromising product efficacy. Therefore, controlling and preventing contamination is essential to ensure product safety and this can be achieved through the process of Risk Assessment.Risk assessment is a systematic process that identifies,…
Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. Dissolution testing of solid oral dosage forms has been used…
Yesterday, I started working through the Noyes-Whitney equation with the intrinsic dissolution rate (k2). Today, let’s discuss the impact of surface area on dissolution. The equation shows us that as the surface area of a formulation increases, so does the dissolution rate. Using this, a formulator can greatly increase or decrease the dissolution rate of…
Scaling up the tablet dosage form preparation process, particularly through wet granulation, is a critical task in pharmaceutical manufacturing. As we transition from pilot to production scales, managing liquid addition is crucial to maintaining consistent dissolution profiles and ensuring tablet efficacy. Here’s an expanded view on how to effectively handle this process. Challenges in Scaling…
Expiration date: The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used. Retest date: The date when a material should be reexamined to ensure that it is still…
