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

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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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Major shift ahead in how FDA regulates drug quality: PwC

• Recommended FDA cGMP online training programs and courses by SkillsPlus Intl Inc.

Updated June 27, 2022

The link to the original source article broke.

---  the original post follows below  ---

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

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Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
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FDA Studying How it Can Use Drones to Conduct Inspections | RAPS

Read the full article: FDA Studying How it Can Use Drones to Conduct Inspections | RAPS:

"While there is currently "no formal drone program in development," the agency is currently "conducting preliminary feasibility testing on possible applications for drone technology in fulfillment of the agency's mission," Andrea Fischer, an FDA spokeswoman, told Focus.

Using drones during FDA inspections of manufacturing facilities could have far-ranging implications. Inspections could, for example, much more easily survey an entire manufacturing site, which can sometimes span several acres and include difficult-to-access sections, such as rooftops. In agricultural settings, in particular, the use of drones might allow FDA to survey an entire site much more easily."

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Improving Documentation of GMP Procedures - Natural Products Insider

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

Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.

Improving Documentation of GMP Procedures - Natural Products Insider:

"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:

• Document all procedures in manufacturing operations.
• Maintain all records for plant and equipment cleaning processes.
• Mandate techniques for product sampling.
• Ensure approval by QC personnel for all procedures, tests, controls and deviations.
• Implement a control process for product labeling.
• Require QC personnel to provide results of initial or final products.
• Provide a procedure to follow if documented specifications are not met.
• Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."

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Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Updated September 4, 2024

The original link broke.

You can still read about the same topic here, on Natural Products Insider:

https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-in-supplement-industry

---  the original post follows below  ---

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

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FDA Proposal - Head Off More Drug Shortages

Updated December 19, 2020

You might be more interested in this:

Drug Shortages - FDA.gov

- - -  original post follows below  - - -

FDA proposal aims to head off more drug shortages:

"The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

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FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

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Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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GMP posters! QSR posters! Posters Posters Posters!

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This product line has been discontinued

As many trainers and managers know, creating excitement about the next training topic or  keeping the compliance message alive after training is always a challenge.

This line of large posters, created by the well-known San Francisco artist Francis Redman, attracts attention and reinforces key compliance messages.

This product line has been discontinued

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Live Onsite QSR Training - Essentials for Medical Device Manufacturers

Here's one of our popular onsite QSR training classes:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Upon completion of this class, students will be able to:

1. State the historical development of QSR regulations. 
2. Explain the role and function of standard operating procedures. 
3. Describe the personal role for contamination control. 
4. Identify the sources of contamination. 
5. List the common QSR documentation practices. 
6. Explain material controls. 
7. State the common practices of production and process controls. 
8. Explain the importance of an adequate, appropriate, and sufficient building design. 
9. State the requirements of equipment design and construction. 
10. List the requirements for building, and equipment cleaning and maintenance. 
11. Explain the role of the quality management system. 
12. Explain the role of the laboratory.

Learn more about this class:
Essentials for Medical Device Manufacturers - On-site training by SkillsPlus International Inc.

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