Subject: QA/QC

Navigating the Stability Universe

There is a universe of individuals, departments, and contract organizations outside the direct control of the Stabilitarian which interact with the stability process in ways that can boost or hinder the success of the program. Some of these are obvious while others go virtually unrecognized, yet members of both can impact us severely and deserve… Continue reading Navigating the Stability Universe

Pharmaceutical Technology Transfer and Project Management

Gain a fundamental comprehension of technology transfer in the pharmaceutical industry, including the transfer of analytical methods, quality control standards, packaging components/operations, and various dosage forms from R&D to manufacturing. This course provides an overview of scale-up and technology transfer of solid dosage forms, injectables, and semisolids. During the course, we will delve into the… Continue reading Pharmaceutical Technology Transfer and Project Management

Ensuring Your Supply Chain through Supplier Qualification

The Covid-19 pandemic highlighted the significance of effectively managing pharmaceutical and medical device supply chains. Previously hidden or overlooked vulnerabilities in the supply chain led to production disruptions and, in some cases, product shortages. To ensure regulatory compliance and sound business practices, supplier qualification is the foundation of effective supply chain management for pharmaceuticals and… Continue reading Ensuring Your Supply Chain through Supplier Qualification

GXP Foundations

GXP represents a collection of regulations and guidelines that encompass best practices for various crucial aspects of medical product development. Due to the intricate regulatory environment and the distinctiveness and diversity of medical product innovations, it can be challenging for sponsors to establish a framework for product development and marketing that satisfies regulatory requirements while… Continue reading GXP Foundations

Spray Drying: Advanced Technology Overview

This accredited course focuses on Spray-Drying technology, a very important process in numerous industries. The course will emphasize the scientific fundamentals and practical operational aspects of Spray-Drying that are seen day-to-day in industries such as Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc. The primary goal will be to help scientists, engineers, and operations professionals… Continue reading Spray Drying: Advanced Technology Overview

Excipients: Compliance with Compendial and GMP Requirements

Excipients are crucial in the manufacturing and formulation of bio/pharmaceuticals, enabling medicines to be delivered to patients in need. Compliance with appropriate quality and regulatory requirements is essential for companies that manufacture, distribute, and use excipients. The United States Pharmacopeia-National Formulary (USP-NF) requires that official substances be prepared according to recognized principles of good manufacturing… Continue reading Excipients: Compliance with Compendial and GMP Requirements

Auditing Stability Programs

A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and… Continue reading Auditing Stability Programs

Cleaning Validation: Best Practices

Cleaning validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur, indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a… Continue reading Cleaning Validation: Best Practices

An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies

Clinical studies are essential to ensuring the safety and effectiveness of new drug products before they are launched. The cornerstone of these studies is the clinical supplies, which must be properly labeled and prepared to ensure patient safety as well as prevent expensive clinical trial delays. To provide a high-level overview and introduction to the… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies

Effective Handling of cGMP Raw Materials

cGMP raw materials are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is an integral and essential process that ensures drug product quality, purity and potency. Drug product manufacturers must have… Continue reading Effective Handling of cGMP Raw Materials