GMP Tips

Johnson and Johnson has had a very good reputation over the past century. Consumers knew they could TRUST products manufactured by J & J. So far this year J & J has issued eleven recalls, ranging from Tylenol and Infant’s Tylenol, to contact lenses and hip implants. J & J’s CEO said he knows that they’ve let consumers down.

Read a recent article about J & J’s woes this year. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles/

GMP Tip

Johnson and Johnson’s widespread problems this year suggest a systemic root cause. Eleven recalls across multiple operating divisions is a very serious situation. This situation is not caused by operators making mistakes or lab analysts using expired reagents in testing. The leadership in any organization sets the tone and establishes the priorities. Has J & J lost its way? Have they taken their eye off of their North Star - their guiding principles?

What is your organization doing to ensure that everyone is focused on doing the right things and using GMP as a North Star to navigate towards making quality products consistently and earning and maintaining the TRUST of your customers?

Download a complimentary copy of our e-book - GMP Makes Good Business Sense. Go to:
www.gmptrainingsystems.com/get-free-ebook

This will help you and your management team integrate GMP compliance into the fabric of your company.

www.GMPTrainingSystems.com
Serving 1807 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

How EU Regulators Conduct Their Inspections: Being Prepared
Sept 17

How to Implement FDA’s New Guidance on Process Validation
Sept 24

Environmental Monitoring - Getting It Right
Oct 1

Defining Risk and Risk Levels - ICH Q9 Examined and Explained
Oct 8

Recent EU GMP Trends: Staying Current
Oct 15

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GMP Tip

The European Medicines Agency has posted a Q&A on GMP on their web site. Find it here: http://snipurl.com/10pprq

We have two terrific web seminars coming up in Sept and Oct dealing with the EU GMP. Learn more here:
www.gmptrainingsystems.com/web-seminars

www.GMPTrainingSystems.com
Serving 1801 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

How EU Regulators Conduct Their Inspections: Being Prepared
Sept 17

How to Implement FDA’s New Guidance on Process Validation
Sept 24

Environmental Monitoring - Getting It Right
Oct 1

Defining Risk and Risk Levels - ICH Q9 Examined and Explained
Oct 8

Recent EU GMP Trends: Staying Current
Oct 15

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

For several years FDA has been telling us to “Use good science.” Nitrox, Inc. just received a Warning Letter with the following observation.

“Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR § 211.160(b)].”

GMP Tip

Make sure that you are using good science in all aspects of your business. Read this Warning Letter issued to Nitrox, Inc. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles.

www.GMPTrainingSystems.com
Serving 1799 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Aug 13

How to Implement FDA’s New Guidance on Process Validation
Sept 24

Environmental Monitoring - Getting It Right
Oct 1

Defining Risk and Risk Levels - ICH Q9 Examined and Explained
Oct 8

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

FDA recently issued a 483 Observation Report to a Johnson & Johnson Merck Consumer facility in Lancaster, PA. Several observations focused on the company not being able to produce documents for several days. This certainly casts suspicion among the FDA inspectors.

Examples of documents not readily available include:

• Organizational charts
• CAPA reports
• Annual Product Review reports
• Listings of new and discontinued products
• Deviation reports
• Maintenance logs

GMP Tip

To facilitate a quick FDA inspection have a robust document management system in place. With an effective document management system, you can find and produce documents that FDA inspectors may want to review without delay.

Read the FDA-483 report issued to a facility of Johnson & Johnson Merck Consumer in Lancaster, PA on July 9, 2010. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com
Serving 1797 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Aug 13

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

A division of Abbott Labs received a Warning Letter from FDA on July 2, 2010. This is Abbott’s 18th Warning Letter since 1997 - not to mention the costly Consent Decree and $100M fine from 1999.

GMP Tip

Read Warning Letters like this one recently issued to a division of Abbott Laboratories to gain insights into the FDA inspection process. Since this is Abbott’s 18th Warning Letter since 1997, imagine the additional cost accrued by Abbott in responding to these actions.

It is far less costly and less stressful to operate in a state of control. Ongoing GMP training helps pave the pathway to GMP compliance. How are you doing in this area?

www.GMPTrainingSystems.com
Serving 1794 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Aug 13

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

FDA Commissioner Margaret A. Hamburg, M.D., recently gave a speech in which she described FDA’s efforts at strengthening regulatory science. Understanding FDA’s position will help you better prepare for your next FDA inspection.

GMP Tip

Read FDA Commissioner Hamburg’s speech on FDA’s efforts to strengthen regulatory science. Go to: www.gmptrainingsystems.com/resources
Click on FDA Resources

www.GMPTrainingSystems.com
Serving 1791 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

Oct 20 - 21 GMP Boot Camp Newark, NJ

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

FDA Inspections: How to Prepare
July 23

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Aug 13

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

FDA has opened a period of public comment on several records collection issues with the dietary supplement GMP regulation. FDA called records an “indispensable component” of GMPs, noting the records required will provide a foundation for the planning, control, and improvement processes that constitute a quality control system. “Implementation of these processes in a manufacturing operation serves as the backbone to CGMP,” FDA wrote.

GMP Tip

Read the notice about public comment on records in the Dietary Supplement GMP published in the Federal Register on July 8, 2010. Go to: www.gmptrainingsystems.com/resources
Click on FDA Resources

www.GMPTrainingSystems.com
Serving 1789 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

Sept 22 - 23 GMPs for Dietary Supplements Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

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

FDA Inspections: What to Expect
July 16

FDA Inspections: How to Prepare
July 23

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
Aug 6

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

FDA recently issued a Warning Letter to Piezosurgery Inc. for not managing their Customer Complaints within the requirements of the Quality System Regulation (21CFR Part 820). Read the Warning Letter. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles.

GMP Tip

View Customer Complaints as Good News. Good news in that the customers who take the initiative to complain are giving us two things. 1) A second chance to keep them as customers, and 2) Valuable data on how we can improve in the future. Manage your complaints effectively and you will be able to spot patterns or trends that will help you prevent these issues from occurring in the future.

www.GMPTrainingSystems.com
Serving 1786 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

July 14 - 15 GMP Boot Camp - Fundamentals of GMP and QSR Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

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

FDA Inspections: What to Expect
July 16

FDA Inspections: How to Prepare
July 23

Implementing FDA’s Guidance on a Quality Systems Approach to Pharmaceutical cGMP Regulations
July 30

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

FDA discovered tablets left from previous runs in packaging and labeling equipment. This is among several violations listed in a Warning Letter issued to L. Perrigo Company by FDA. They also shipped tablets contaminated with metal shavings.

GMP Tip

Read Warning Letters like this one to see what FDA considers important and how FDA interprets the words in the GMP regulations like “adequate,” “as necessary,” “appropriate,” and other “weasel words.” Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles and scroll down.

www.GMPTrainingSystems.com
Serving 1784 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

July 14 - 15 GMP Boot Camp - Fundamentals of GMP and QSR Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

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

FDA Inspections: What to Expect
July 16

FDA Inspections: How to Prepare
July 23

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

FDA has fined the American Red Cross $16M for GMP violations. FDA has already sent 12 letters and imposed over $21M in fines since 2003, not including this latest fine.

GMP Tip

The American Red Cross is caught up in a costly cycle of non-compliance. Preventing contamination, mix-ups, and errors is ALWAYS less expensive than correcting problems. Do you emphasize Preventive Action in your Corrective and Preventive Action (caPA) program?

www.GMPTrainingSystems.com
Serving 1783 clients since 1996

Upcoming Boot Camps
www.gmptrainingsystems.com/public-workshops

July 14 - 15 GMP Boot Camp - Fundamentals of GMP and QSR Anaheim/Newport Beach, CA

Sept 22 - 23 Validation Boot Camp Philadelphia, PA

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

FDA Inspections: What to Expect
July 16

FDA Inspections: How to Prepare
July 23

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