Tuesday, January 13, 2015

US FDA launches overarching Office of Pharmaceutical Quality - iPT

Read the full article: US FDA launches overarching Office of Pharmaceutical Quality - iPT:

"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."

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Friday, January 2, 2015

New! - 2015 cGMP Training Course Catalog - by SkillsPlus Intl Inc.


Get ready for 2015 cGMP training
  1. Are you planning your CGMP training schedule for 2015? 
  2. Do you wish you had more instructors?
  3. Do you need more time to develop the courses?
If you answered yes to any of the questions above, then take a look at our current list of classes that we can bring to your plant site.
Current Course Listing 
Allan Dewes
Allan Dewes - President
of SkillsPlus Intl Inc.
  1. GMP Essentials for Drug Manufacturers
  2. GMP Olympics Annual Update
  3. Qualstar: A Pharmaceutical CGMP Simulation
  4. Executive Session Annual Update: GMPs
  5. FDA Inspection Training
  6. Auditing for Compliance
  7. Root Cause Analysis for Better Deviation Investigations
  8. Writing Better Investigation Reports
  9. Advanced Root Cause Analysis Investigator Training
  10. Writing More Effective Procedures
  11. Critical Thinking Skills
  12. Creating Responsibility and Accountability
  13. Risk Assessment: Failure Mode Effects Analysis (FMEA)
  14. Overcoming Human Errors
  15. Train-the-CGMP Trainer Workshop

View our catalog:  

If you don't see what you need, just give us a call at (415) 948-5220.


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FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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Friday, December 19, 2014

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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Saturday, November 29, 2014

Thursday, November 20, 2014

FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer

Read the full article: FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer:

"These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements.   Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.

FDA does not bring a lot of injunction cases per year.  Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency."

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Wednesday, November 19, 2014

FDA - News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality

Read the full article: News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality - FDA.gov

"Lucinda Buhse, PhD, acting director, Office of Testing and Research, Office of Pharmaceutical Science, discusses efforts underway in FDA’s laboratories to help assure high-quality drug products are available for the public."

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The article covers:
  • Assessing pharmaceutical quality
  • Measuring pharmaceutical quality across the drug lifecycle
  • FDA’s additional roles in safeguarding quality
  • Research and innovation in CDER’s drug quality testing program
  • Continuing to help protect consumers from harm
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Tuesday, November 11, 2014

FDA - Constituent Updates > New CFSAN Center Director Announced

Read the full article: Constituent Updates > New CFSAN Center Director Announced - FDA.gov:

"The U.S. Food and Drug Administration today announced a change in leadership at the Center for Food Safety and Applied Nutrition. In January 2015, Dr. Susan T. Mayne will take the reins from Michael M. Landa, who has led the Center since 2010, providing critical leadership on major food safety and nutrition initiatives.

Mayne is an internationally recognized public health leader and scientist, who is also known as an outstanding administrator and coalition builder. With rigorous training in nutrition, toxicology, and epidemiology, she understands the fundamental relationship between science and FDA’s public health mission"

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Thursday, November 6, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS

Read the full article: It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS:

"According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data."

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Thursday, October 23, 2014

Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

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Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

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Thursday, October 2, 2014

Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

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Download the document:  FDA Strategic Priorities 2014-2018 (pdf)

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Wednesday, October 1, 2014

The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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Tuesday, September 16, 2014

Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor

More insights in the full article: Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor:

"In the wake of the recent FCPA enforcement activity, the government has signaled its renewed attention to pharmaceutical companies. It is therefore imperative that pharmaceutical companies doing business abroad assess their individual risks, develop compliance goals, and create and implement a comprehensive compliance program that evolves in conjunction their risk profile and ever-changing enforcement trends."

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Saturday, September 13, 2014

Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org

Read the rest of the abstract: Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org:

"Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries."

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Read the study paper:
Poor Quality Drugs and Global Trade: A Pilot Study (Roger Bate, Ginger Zhe Jin, Aparna Mathur, Amir Attaran). NBER Working Paper No. 20469. Issued in September 2014 (PDF)

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Friday, September 12, 2014

FDA could be source of innovation, Hamburg says - Denver Business Journal

Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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Wednesday, September 10, 2014

FDA - Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

Read the full announcement: Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations - FDA.gov:

"The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically."

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Thursday, August 21, 2014

Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post

Read the full article: Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post Business Page, Business News:

"The breaches have forced companies to boost efforts to protect their computer banks. On average, health-care companies spent $2.2 million on information security in 2013, a more than 20 percent increase from the prior year, according to a PwC, CIO and CSO magazine survey.

“I recently met with three CEOs in health care and in most cases they had come to the conclusion that they definitely did under-invest,” said Mick Coady, a partner at PwC’s health information privacy & security group. “Health care is at least a decade, if not more, behind.”"

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