Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.
- Is The U.S. Ready For A Re-shored Pharma Supply Chain?
- Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs)
- A Brief History Of Parenteral Process Validation — How We Got Here
- Are We Adequately Assessing U.S. Pharma Supply Chain Risks?
- The Compounded Risk Of Early-Stage Biopharma Licensing Deals
- Key Engineering & Facility Considerations For Liposome Manufacturing
- Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness
Is The U.S. Ready For A Re-shored Pharma Supply Chain?
In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.
Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs)
The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.
A Brief History Of Parenteral Process Validation — How We Got Here
Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.
Are We Adequately Assessing U.S. Pharma Supply Chain Risks?
There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.
Key Engineering & Facility Considerations For Liposome Manufacturing
This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.
Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness
Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you'll want to avoid when dealing with OEE.
4 Preparatory Moves For A Post-COVID World
While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.
Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned
IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S.
PHARMA ONLINE WHITE PAPERS
Golden Retriever Study: 5 Years Of Progress In Vet Health And Biobanking
An overview of a prospective cohort study of some 3,000 young Golden Retrievers, and how extensive data and biological samples will be used for future analyses of major diseases, disorders, or conditions..
The Keys To Superior Containment In Compounding Applications
This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process.
Overcoming Encapsulation Issues Caused By Sticky Formulations
This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation.
Developing A Scalable Process For Adenovirus Manufacturing
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Considerations When Cleaning Your Tablet Presses & Tablet Tooling
Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Dirty tools cause tableting and product quality-related problems, such as sticking & picking. Keeping tools clean also decreases premature tool, turret and cam wear, and reduces the risk of product cross-contamination. While most cleaning methods can achieve similar results, utilizing an automated cleaning system, such as an ultrasonic wash with rinse and dryer, can ensure tooling is properly cleaned and dried consistently with limited handling and potential for damage. A warm air-drying process is ideal for preventing moisture and corrosion by pushing warm air through areas, such as key slots, punch cups, and die bores, that may not be dried properly with a traditional towel or cloth.
Water Activity Determination Of Oral Solid Dosage Products Using Frequency Modulation Spectroscopy
Controlling water content in oral solid dosage (OSD) products, and dry pharmaceutical products in general, is essential to maintaining efficacy and safety. Measuring the water activity at multiple time points during the product life-cycle will correlate to changes in critical quality attributes such as degradation of the active ingredient, changes in the dissolution or disintegration rate, and changes in physical properties such as hardness or friability.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
PHARMA ONLINE PRODUCTS & SERVICES
PHARMA INDUSTRY EVENTS
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works
July 15 - 15, 2020
1pm-2:30pm EST, Online Training
Regulatory Affairs in China – The New Drug Regulatory Framework
July 16 - 16, 2020
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them
July 23 - 23, 2020
1pm-2:30pm EDT, Online Training
FDA REMS Inspection Guide: Audit Preparedness Best Practices
July 29 - 29, 2020
1pm-2:30pm EST, Online Training