Pharma Digest
Necessity of Thorough Deviation and Complaint Investigations
One of the most frequently cited issues during FDA inspections pertains to the failure to conduct thorough investigations regarding unexplained discrepancies. Once an investigation is conducted and findings are documented, 21 CFR 211.192 emphasizes the necessity of implementing follow-up actions to prevent the recurrence of discrepancies or product failures. Companies ... Read More
Mock FDA Inspections for Cleaning Validation
Cleaning validation is a crucial aspect of pharmaceutical manufacturing that ensures the removal of product residues, cleaning agents, and contaminants from manufacturing equipment. Inadequate cleaning can lead to product contamination, cross-contamination, and reduced product quality. Scope of FDA Warning Trend = In fiscal year 2023, the FDA issued 180 warning ... Read More
Understanding the FDA 483 Warning Letter
FDA Form 483 = Official notification issued at the conclusion of a facility inspection when FDA investigators identify conditions that may violate the FD&C Act and related regulations. Consists of observations regarding practices that may lead to the adulteration of products or pose health risks. Navigating the FDA 483 Warning ... Read More
Understanding Stratified Sampling in Pharmaceutical Industry
FDA recommends the necessity of statistically sound sampling plans [Intra-Location (within a single location) Variability and Inter-Location (between locations) Variability] and acceptance criteria [acceptable range of deviation from the mean content, the variability of measurements, and the percentage of units falling within predetermined limits is based on statistical principles] to ... Read More
Process Validation | The Foundation of Quality Products
Process Validation Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product ... Read More
Excellence in Change Management | Industry Best Practices for QMS
Change Management is a critical process within a Quality Management System (QMS) that ensures all modifications are systematically evaluated, implemented, and verified to maintain compliance, quality, and efficiency. Following are the critical stages or steps as a part of the Change Management process are: Raise a Change Request Cross Functional ... Read More
A Brief Overview of the 505 Regulatory Pathways
The FDA recognizes three primary pathways for the approval of new drugs and abbreviated new drug applications (ANDA): the 505(b)(1) NDA, 505(j) ANDA, and 505(b)(2) NDA. Each pathway serves a distinct purpose in the drug approval process. 505(b)(1) NDAThe 505(b)(1) NDA is a comprehensive application that relies entirely on original ... Read More
505(b)(2) Submission Process
The 505(b)(2) submission journey involves four crucial steps: candidate identification, candidate assessment, product planning, and the pre-IND meeting. Candidate IdentificationThe first step involves selecting drug products compatible with the 505(b)(2) pathway, a crucial action that mitigates the risk of failure. It typically involves a few nonclinical studies. During Phase 1, ... Read More
Difference Between C8 and C18 Columns
C8 and C18 are both types of reverse-phase chromatography columns, but they differ in their: Carbon chain length: Hydrophobicity: Retention characteristics: Separation range: Column selectivity: In summary, C8 columns are used for smaller, more polar molecules, while C18 columns are used for larger, more non-polar molecules. The choice between C8 ... Read More
Formulation of the Pharmaceutical Enzymes
Formulating enzymes products presents unique challenges in maintaining stability, activity, and functionality. Here are the key areas to consider: Enzyme Stability Enzyme Activity Formulation Compatibility Preparation and Mixing Compression (for Tablets) Storage Stability Regulatory and Quality Assurance Successfully formulating enzyme products involves strategic formulation, strict process controls, and comprehensive testing ... Read More
TIP Speed Calculation for RMG Process Scale-Up
Scaling up in pharmaceutical manufacturing, especially with Rapid Mixer Granulators (RMG), requires careful attention to “Motion similarity between lab RMG and production Large RMG “, particularly in maintaining consistent “tip speed”. Here’s why this is crucial:Tip speed—the speed at the edge of the rotating impeller directly affects mixing efficiency and ... Read More