As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.
- Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?
- A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity
- Comparing The Top 10 Pharma Inspection Findings From FDA, MHRA, & Russia’s Ministry Of Health
- Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements?
- A Quality Agreement Primer: Managing Risk When Working With Contractors
- Overcoming The Challenges Of Patient-Centric Specification Setting
- Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery
Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?
Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.
A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity
This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.
Comparing The Top 10 Pharma Inspection Findings From FDA, MHRA, & Russia’s Ministry Of Health
Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.
Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements?
The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.
A Quality Agreement Primer: Managing Risk When Working With Contractors
This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.
Overcoming The Challenges Of Patient-Centric Specification Setting
The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.
Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery
Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems. This article raises a number of points to discuss with equipment suppliers and your facility engineers to plan for and assure a successful and compliant installation.
ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices
This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.
PHARMA ONLINE WHITE PAPERS
Data Gathering And Analysis Necessary In New Tablet Development
A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.
Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing
Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.
Lipid Formulations To Enhance Bioavailability In Early Development
To prevent delays and costly issues during molecular development, it is important to understand potential mechanisms of increased absorption with lipid formulations and the appropriate screening tools.
Choosing A Formulation And Process Approach To Oral Controlled Release Products
Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. Understanding the options and their ramifications is the first step toward devising a plan.
Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements
Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
Water Activity And Primary Packaging Selection For Oral Solid Dosage Products
The draft of the new general chapter USP<922> states that water activity determination can be used to assess the level of protection provided by primary packaging for an oral solid dosage (OSD) product over its entire shelf life. Water activity (Aw) measurements provide unique information, and therefore expand and complement the data collected from USP<670> Auxiliary Packing Components and USP<671> Containers - Performance Testing.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Whether you’re trying to coax a toddler into taking cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
PHARMA INDUSTRY EVENTS
Keeping HIPAA and Patient Privacy in Health Care when Working from Home, Including Telepractice of Mental Health
October 20, 2020
Purifying Samples For Cryo-EM Preps
October 20, 2020
Ocular Drug Delivery - A Review Of New And Emerging Material, Formulation And Process Development Opportunities
October 20, 2020
Excel Top 10 Functions and How to Use Them - Turn Your Business Data Into Insightful Information
October 21, 2020
Psychedelic Drug Development Digital Summit
October 21 - 22, 2020
China GCP 2020: Understanding and Implementing New Compliance Requirements
October 29 - 29, 2020
11am-12:30pm EDT, Online Training