GMP Tips

Abbott gets 1999 Consent Decree lifted – FINALLY

GMP Training Systems — Tue, 15 May 2012 16:48:46 +0000

After more than a dozen years, Abbott Laboratories is no longer operating under a consent decree. The settlement was made in 1999 after a remarkable six-year run of manufacturing deficiencies and subsequent failures to fix various problems in its diagnostics division. The decree was terminated in April 2012, according to an Abbott spokeswoman.

The move came after the drug and device maker was able to demonstrate an ability to remain in compliance with good manufacturing practices. “Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one,” an FDA spokeswoman said.

GMP Tip

Imagine the costs associated with complying under the court-ordered conditions over the past twelve years. It is far less expensive and far less stressful to comply with cGMP in the first place. Most companies do not survive a Consent Decree of this magnitude.

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Serving 2025 clients since 1989

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FDA Commissioner defines “Regulatory science”

GMP Training Systems — Mon, 07 May 2012 16:30:23 +0000

FDA Commissioner Margaret Hamburg, M.D. defined Regulatory science in a recent speech. Here’s what she said.

“Regulatory science is the science needed to assess and evaluate a product’s safety, efficacy, quality, and performance. It involves the development of new methods, standards and models we can use to speed the development, review, approval and ongoing oversight of medical products.”

Read her entire speech. Go to www.gmptrainingsystems.com/resources
Click on FDA resources.

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Serving 2023 clients since 1989

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Click below for our 2012 schedule
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Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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Parents Sue J & J for Death of Infant

GMP Training Systems — Mon, 30 Apr 2012 16:13:22 +0000

Parents say in court that contaminated Tylenol drops killed their infant son just 13 days before Johnson & Johnson recalled more than 136 million bottles of children’s Tylenol – the largest recall of children’s medicine in history.

Read a news account of this lawsuit as well as a news account of J&J’s struggles to get the plant that manufactured the contaminated Tylenol back in business.

Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

This continues to demonstrate the high cost of not complying with GMP.

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Serving 2021 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
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GMP Boot Camp – Fundamentals of GMP and QSR
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GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
May 4

Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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Ask J&J about the Cost of Non-compliance

GMP Training Systems — Mon, 23 Apr 2012 16:25:34 +0000

Johnson & Johnson continues to lose hundreds of millions of dollars a year because of manufacturing quality problems. The company is operating under increased government oversight (FDA) and was forced to gut and rebuild a huge factory in suburban Philadelphia.

J&J has been plagued by nearly 30 recalls since September 2009 for Tylenol and a host of other nonprescription medicines, plus faulty hip implants and contact lenses and a couple of its prescription drugs.

It’s also recently been hit by a fine of more than $1.1 billion from an Arkansas judge for downplaying and concealing risks of its former blockbuster schizophrenia drug Risperdal, such as major weight gain and developing diabetes. That ruling, which will be appealed, could affect dozens of pending lawsuits over the drug, many by states seeking reimbursement for what their Medicaid programs paid for the drug.

In December, a South Carolina judge upheld a $327 million civil penalty against J&J over Risperdal, and in January the company reached a $158 million settlement with Texas in which it didn’t admit fault. J&J also is negotiating a settlement with the federal government that’s expected to exceed $1 billion.

GMP Tip

Compliance with GMP is ALWAYS less expensive than non-compliance. Share this news about J&J with your management team if they balk at the cost of compliance.

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Serving 2019 clients since 1989

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Making GMP a Lifestyle in your Company, NOT Just a Regulation
Apr 27

GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
May 4

Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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FDA Starts Pilot Program with Third Party Audits of ISO 13485

GMP Training Systems — Mon, 16 Apr 2012 16:30:37 +0000

FDA just issued a new guidance on Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

Read it here: www.gmptrainingsystems.com/resources
Click on FDA Resources

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Serving 2015 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
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GMP Boot Camp – Fundamentals of GMP and QSR
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Upcoming web seminars
Cost effective & Convenient – in your office or conference room
www.gmptrainingsystems.com/web-seminars

Master Planning for Validation
Apr 20

Making GMP a Lifestyle in your Company, NOT Just a Regulation
Apr 27

GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
May 4

Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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New Guidances Planned by FDA CDER in 2012

GMP Training Systems — Mon, 09 Apr 2012 16:30:11 +0000

FDA has published a list of new and revised guidances for 2012 by CDER (Center for Drug Evaluation and Research).
Find it here: www.gmptrainingsystems.com/resources
Click on FDA Resources

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Serving 2014 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp – Fundamentals of GMP and QSR
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Upcoming web seminars
Cost effective & Convenient – in your office or conference room
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Implementing an Effective CAPA Program
Apr 13

Master Planning for Validation
Apr 20

Making GMP a Lifestyle in your Company, NOT Just a Regulation
Apr 27

GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
May 4

Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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New FDA Guidance on ICH Q8, Q9, & Q10 Implementation

GMP Training Systems — Mon, 02 Apr 2012 16:28:56 +0000

FDA recently issued a Guidance Document clarifying issues with the implementation of ICH Q8 (Quality by Design), Q9 (Quality Risk Management, and Q10 (Pharmaceutical Quality System).

Find this new guidance at www.gmptrainingsystems.com/resources
Click on FDA Resources

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Serving 2011 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp – Fundamentals of GMP and QSR
May 9 – 10 Newark, NJ
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Upcoming web seminars
Cost effective & Convenient – in your office or conference room
www.gmptrainingsystems.com/web-seminars

How to Investigate Deviations and Failures Effectively
Apr 4

Implementing an Effective CAPA Program
Apr 13

Master Planning for Validation
Apr 20

Making GMP a Lifestyle in your Company, NOT Just a Regulation
Apr 27

GMP, Validation, and Change Control: Optimizing Key Elements of an Effective Compliance Program
May 4

Proven Steps in Reducing Waste in Process Validation
May 18

Introduction to GMP: Orientation for New Employees
June 1

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FDA on Cleaning Logs and Labels

GMP Training Systems — Mon, 26 Mar 2012 17:12:15 +0000

Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file?

Read FDA’s answer to this question. Go to www.gmptrainingsystems.com/resources
Click on FDA Resources

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Serving 2010 clients since 1989

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Upcoming web seminars
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How to Investigate Deviations and Failures Effectively
Apr 4

Implementing an Effective CAPA Program
Apr 13

Master Planning for Validation
Apr 20

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Recalled Products UP for 5th Straight Year

GMP Training Systems — Mon, 19 Mar 2012 21:18:52 +0000

Recalled products are on the rise. Find other Compliance and Enforcement Statistics from FDA that you can use in your GMP training sessions.

Go to: www.gmptrainingsystems.com/resources
Click on FDA Resources

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Serving 2008 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
www.gmptrainingsystems.com/public-workshops

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
May 9 – 10 Newark, NJ

Upcoming web seminars
Cost effective & Convenient – in your office or conference room
www.gmptrainingsystems.com/web-seminars

Introduction to GMP: Orientation for New Enployees
Mar 23

How to Investigate Deviations and Failures Effectively
Apr 4

Implementing an Effective CAPA Program
Apr 13

Master Planning for Validation
Apr 20

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FDA Commissioner speaks out on Generics

GMP Training Systems — Mon, 12 Mar 2012 16:27:25 +0000

FDA Commissioner Dr. Margaret Hamburg recently addressed a meeting of the Generic Drug industry. Read her remarks here: www.gmptrainingsystems.com/resources
Click on FDA Resources

GMP Tip

Incorporate insights gained from speeches like these by FDA into your GMP training sessions. Circulate these speeches to your management and leadership team to reinforce the importance of cGMP compliance.

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Serving 2003 clients since 1989

Upcoming Boot Camps
Click below for our 2012 schedule
www.gmptrainingsystems.com/public-workshops

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
May 9 – 10 Newark, NJ

Upcoming web seminars
Cost effective & Convenient – in your office or conference room
www.gmptrainingsystems.com/web-seminars

Defining Risk and Risk Levels: Implementing ICH Q9 Quality Risk Management
Mar 16

Introduction to GMP: Orientation for New Enployees
Mar 23

How to Investigate Deviations and Failures Effectively
Apr 4

Implementing an Effective CAPA Program
Apr 13

Master Planning for Validation
Apr 20

Please forward this to others in your organization who may benefit.