Pharma Digest
Deviation Management and Root Cause Analysis
In the life sciences industry, maintaining the highest quality standards is non-negotiable. Deviations, or departures from established procedures, are inevitable, but how we manage them makes all the difference. Here’s why Deviation Management and Root Cause Analysis (RCA) are pivotal: Ensuring Compliance and Safety: Systematic Investigation: Preventative Measures: Continuous Improvement: ... Read More
Surfactants in Dissolution
We have many factors to consider when making a dissolution method. What apparatus, speed, filter choice, etc. Of these factors, the one I get the most questions about is media selection – especially surfactants in media selection. So, what is a surfactant and why do we use them? What do ... Read More
How Do Regulated Companies Balance Quality and Compliance
First of all quality and compliance are related but distinct concepts. Quality refers to the degree to which a product or service meets or exceeds customer expectations. It’s about delivering value and ensuring satisfaction. Compliance, on the other hand, involves adhering to laws, regulations, standards, and guidelines set by external ... Read More
FDA Queries Related to Drug Substances in the CMC
There are few common queries related to drug substances in the CMC (Chemistry, Manufacturing, and Controls) section. Here’s an example: 3.2. S DRUG SUBSTANCE3.2. S.1 General Information 3.2. S.1.1: Nomenclature SectionQueries: 1. USAN, BAN, IUPAC, names, CAS not provided until. 3.2. S.1.2: Structure Section Queries:Stereochemistry, Isomerism structure and discussion on ... Read More
Verification of OOS Results | EDQM Guidelines
VERIFICATION OF INITIAL OUT-OF-SPECIFICATION RESULTS SCOPE The objective of this Annex is to describe the steps to follow for the management of out-of-specification (OOS) testing results. The failure investigation may also be triggered if validation criteria defined by the method or laboratory are not met, including out-of-trend (OOT) results. To ... Read More
Difference Among Assay on As is Basis, on Dried Basis and on Anhydrous Basis
A. Assay on an As is basis refers to the measurement of the content of a substance in its original state, without any removal of water or other volatile components. This type of assay is used when the presence of water or other volatile components does not affect the accuracy ... Read More
A Comprehensive Comparison between ANDA (Generics) and Biosimilars
Composition ANDA (Generics): Biosimilars: Approval Process ANDA (Generics): Biosimilars: Manufacturing Challenges ANDA (Generics): Biosimilars: Regulation ANDA (Generics): Biosimilars: Market ANDA (Generics): Biosimilars: Analytical Validation ANDA (Generics): Biosimilars: Process Validation ANDA (Generics): Biosimilars: Supply Chain ANDA (Generics): Biosimilars: Read also:
Basics of Tablet Tooling
Tooling can be defined as tools to craft a particular shape. Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, oblong or bullet shape or any special shape ... Read More
Purpose of Tablet Coating
Tablets are the most commonly used dosage form which are manufactured in Pharmaceutical Industries. Many tablets in pharma are coated and some tablets are uncoated. Tablet coating is the process where we apply a thin coat of film formers & related excipients over the tablet surface. REASONS FOR TABLET COATING ... Read More
Facility Readiness Goal Date Decisions Under GDUFA
The Generic Drug User Fee Amendments (GDUFA) aim to streamline the approval process for generic drugs, ensuring timely access to affordable medications. A crucial aspect of this process is the Facility Readiness Goal Date Decisions, which influence the FDA’s timelines for reviewing and approving generic drug applications. Key Highlights from ... Read More
Vulnerabilities of the Global Supply Chains of Medicine
The availability of medicines has been a longstanding concern in the EU. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems to industry’s competitiveness. In particular, shortages of medicines can result from supply chain disruptions and vulnerabilities affecting ... Read More