Pharma Blog
Cetylpyridinium Chloride (CPC) in Dissolution Bath
Cetylpyridinium chloride (CPC) at 0.01% w/v is often used in a dissolution bath to maintain microbial control and ensure the cleanliness of the system. Its inclusion helps prevent microbial contamination, which could interfere with the dissolution process and affect the accuracy of drug release studies. CPC is a cationic surfactant ... Read More
Differences Between eCTD and ACTD Dossier
eCTD (Electronic Common Technical Document) ACTD (ASEAN Common Technical Dossier) Key Differences Read also: Resource Person: KABYA PRATAP ROYAL
How to Handle CSV in Pharmaceutical Industry
In the pharmaceutical industry, quality is not just an expectation; it’s a regulatory requirement. Computer System Validation (CSV) plays a critical role in ensuring that systems used to manage data and automate processes meet the necessary standards. For QA (Quality Assurance) professionals, overseeing CSV is essential for maintaining compliance and ... Read More
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