Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance Document

• Trusted FDA cGMP online training programs and courses by SkillsPlus International Inc.

According to the final guidance document: 

"Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document), serve a variety of functions, as active ingredient or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form."

Reference:  Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance for Industry - FDA.gov

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FDA names its first medical device cybersecurity director - Fierce Biotech

• FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc. 

According to the article:

"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.

Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

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FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

• FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training 

According to the article:

"Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process.

Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week, while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people."

Read the full news article:  FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

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Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - FDA Guidance

•  FDA GMP QSR cGMP Training - online training classes and courses

View the source FDA Guidance:  Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - Guidance for Industry (PDF)

According to the guidance:

"FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply."

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FDA cGMP QSR GMP Training - online training courses by SkillsPlus Intl Inc.

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 

Learn more, and view the details about CGMP Training: A New Generation Series

Ask yourself these three questions:

1. Do you need to conduct CGMP Training on a limited budget? 
2. Do you want employees to learn the CGMPs from an expert using real examples? 
3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

• 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
• Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
• Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
• Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
• Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
• Plan to Production - Part F. Review the requirements for production process controls and validation.
• Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
• Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
• Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

FDA GMP QSR cGMP Training - online training classes by SkillsPlus International Inc.

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FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

• FDA cGMP QSR GMP Online Training Courses - presented by SkillsPlus International Inc.

Read the full source article:

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

According to the article:

"The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday. 

However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement."

Read the FDA Statement, Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system - FDA.gov

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Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov

• FDA GMP QSR cGMP Training - online training courses by SkillsPlus International Inc.

Read the full FDA Statement:  Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov

In the statement:

"Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products."

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Retail Sales of Tobacco Products - FDA.gov

• FDA GMP QSR cGMP online training classes by SkillsPlus International Inc.

Read the full article:  Retail Sales of Tobacco Products - FDA.gov

"Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available."

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Our Most Popular FDA GMP Online Training Courses

• FDA cGMP QSR GMP Training by SkillsPlus International Inc.
• Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

The most popular GMP online training classes by SkillsPlus Intl Inc.

GMP Trainer Awareness, Certification, & Master Trainer Course

Root Cause Analysis and Investigation Report Writing 

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It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

• FDA GMP cGMP online training courses by SkillsPlus International Inc.

Read the full article:  It's official: New FDA Commissioner Hahn wins Senate confirmation - FiercePharma

According to the article:

"The FDA has been plenty busy without an official commissioner since former head Scott Gottlieb stepped down earlier this year, but now it has a new chief to take on the job.

Stephen Hahn, formerly chief medical officer of the University of Texas MD Anderson Cancer Center, secured confirmation from the Senate Thursday in a 72-18 vote, according to reports. He takes over the agency's sprawling brief, which covers pharmaceuticals, food safety, medical devices and tobacco."

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Report On The State Of Pharmaceutical Quality - FDA.gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.

Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

More information is available at: FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers."

FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday - CNBC.com

• FDA cGMP QSR GMP Training - Online e-learning courses by SkillsPlus International Inc.

Read the full article:  FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday - CNBC.com

"The Food and Drug Administration will hear from CBD manufacturers, researchers, farmers, retailers and more on Friday as the agency holds its first public hearing looking at the sale of what’s being touted as a magical elixir that can treat everything from inflammation to epilepsy."

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SkillsPlus International Inc. Announces Online GMP e-Learning Courses

• FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

• In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 
• Learn more, and view the details about CGMP Training: A New Generation Series

Ask yourself these three questions:

1. Do you need to conduct CGMP Training on a limited budget? 
2. Do you want employees to learn the CGMPs from an expert using real examples? 
3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

• 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
• Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
• Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
• Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
• Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
• Plan to Production - Part F. Review the requirements for production process controls and validation.
• Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
• Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
• Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

FDA.gov Website Refresh - FDA.gov

• FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

Read the full announcement:  FDA.gov Website Refresh - FDA.gov

Images of the new FDA.org website

According to the announcement:

The goals for the improved FDA.gov include:

• Remodeled webpages that can be viewed on any internet-ready device
• Easier access to popular content
• Updated navigation based on data and audience behavior
• Easier to find FDA content in search results
• Better consistency of FDA content across web and social channels

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FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

• FDA cGMP, QSR, and GMP Training Courses by SkillsPlus Intl Inc.

Read the full article:  FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

"The FDA and FTC sent warning letters to three CBD companies making false claims about treating diseases like cancer and Alzheimer’s." 

"The letters claim the companies are falsely advertising the effectiveness of supplements to treat diseases including cancer, Alzheimer’s, fibromyalgia, and neuropsychiatric disorders. This marks the first time the FDA and FTC have issued a joint warning letter together."

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FDA Issues Guidance On Continuous Manufacturing

• cGMP FDA GMP Training Courses by SkillsPlus International Inc.

Updated June 25, 2023

The original link broke.

You might also be interested in:

Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry - FDA.gov (PDF)

---  the original post follows below  ---

Quality Considerations for Continuous Manufacturing - Guidance for Industry

The guidance provides information regarding the FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files (DMFs), biologics license applications (BLAs), and nonapplication over-the-counter (OTC) products. Scientific principles described in the guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, the guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

Source:  Quality Considerations for Continuous Manufacturing - FDA Guidance for Industry (PDF)

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FDA releases statement underlining their powers to manage a selection of cannabis products

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Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov

"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

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Read the full article:   As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

"Although most of the agency's employees weren't working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday. 

However, much of the agency's workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday."

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Data Integrity and Compliance With Drug CGMP Questions and Answers - FDA.gov

• cGMP Training Courses and FDA Training Classes

Read the entire FDA guidance (pdf):  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - FDA.gov

"In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things: . . . "

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