Pharma Blog
How to Create a Validation Master Plan?
Validation master plan (VMP) is a high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of ... Read More
How the ICH Quality Guidelines Fit Into the Drug Development Process
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration ... Read More
GXP Compliance | The Future of Validation
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the ... Read More
Why Change Management is Important during CQV?
Change management is crucial in any Commissioning, Qualification, and Validation (CQV) activity within the pharmaceutical and other regulated industries for several important reasons: Robust change management helps ensure compliance, manage risks, maintain product quality, and facilitate efficient and controlled change implementation. It is an integral part of maintaining the quality, ... Read More
FDA Requirements For OTC Drugs
An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the ... Read More
Different Phases of Clinical Trials
Pre-clinical (or laboratory) Studies Clinical trials are done only after preclinical findings suggest that the new drug or treatment is likely to be safe and will work in people. Pre-clinical studies, also called laboratory studies, include: Cell Studies Animal studies Phase 0 Studies The IND application must contain certain information, ... Read More
Commissioning, Qualification, and Validation (CQV) in Pharmaceutical Industry
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the ... Read More
Hold Time Management in Pharma Manufacturing
Holdtime can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications. 21 CFR 211.111 Time Limitations on Production states: When appropriate, time limits for the ... Read More
Hold Time Study Protocol for Pharmaceutical Products
A Hold Time Study Protocol is a document that outlines the procedures and criteria for conducting a hold time study in a pharmaceutical industry. 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, ... Read More
Difference Between Extractables and Leachables
In the intricate world of biopharmaceutical manufacturing, the presence of extractables and leachables poses a significant challenge, potentially tarnishing the purity of invaluable drug products. The FDA offers precise definitions for these two critical terms: Extractables These are compounds that can be meticulously drawn out from the container closure system ... Read More
Oral Semaglutide (Rybelsus) | Drug Digest
Pharmacologic Category (Oral Diabetes Medicine): Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Mechanism of Action: Stimulates insulin release in the presence of elevated blood glucose. Suppresses Glucagon (inhibits hepatic glucose production); thereby reducing both fasting and postprandial glucose. It delays gastric emptying (slower absorption of sugar and promotes the feeling of fullness). ... Read More