GMP Tips

“The recent Consent Decree of Permanent Injunction filed against Ranbaxy is groundbreaking in its international reach — it requires the company to make fundamental changes to its plants in both the United States and India,” Tony West, assistant attorney general for the U.S. Justice Department’s Civil Division.

Problems uncovered through the investigation by the Justice Department and FDA include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs didn’t meet their specifications; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.

The government also found that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed, according to the U.S. Justice Department’s statement.

Read FDA’s Press Release and a news account with more details. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1991 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
Mar 7 – 8 Anaheim/Newport Beach, CA

Outsourcing Boot Camp
Mar 13 – 14 Philadelphia, PA

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

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

Unraveling the Mysteries of Process Validation: ASTM E2500 Consensus Standard and its Harmony with FDA’s New Guidance
Feb 3

Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Feb 10

FDA Inspections: What to Expect
Feb 17

FDA Inspections: How to Prepare
Feb 24

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

FDA officials warned on January 9 that some of Novartis’ over-the-counter pills, including  Excedrin, Bufferin, NoDoz and Gas-X may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

The Swiss-based company has received hundreds of complaints of broken and chipped pills and inconsistent bottle packaging that could cause pills to be mixed up. Consumers are advised to stop using the products and contact the company for a refund.

GMP Tip

The first and most obvious place to look when a mix-up like this occurs is the Line Clearance process. Apparently this is a systemic problem at the plant. Read an FDA-483 Observation Report issued to Novartis Consumer Health in 2011 as well as a news account of the recall.
Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles.

Conducting a proper Line Clearance requires people who are trained in how to conduct the Line Clearance and what to look for. Most importantly it requires the discipline to conduct the Line Clearance process properly. It cannot be skipped, rushed, or done with untrained people.

www.GMPTrainingSystems.com

Serving 1987 clients since 1989

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

Validation Boot Camp
Feb 14 – 15 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

Outsourcing Boot Camp
Mar 13 – 14 Philadelphia, PA

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

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

EU GMPs: Implications of New Format for QP Declaration for APIs
Jan 27

Unraveling the Mysteries of Process Validation: ASTM E2500 Consensus Standard and its Harmony with FDA’s New Guidance
Feb 3

Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Feb 10

FDA Inspections: What to Expect
Feb 17

FDA Inspections: How to Prepare
Feb 17

Please forward this to others in your organization who may benefit

The latest step in the increased collaboration between European authorities (represented by the European Medicines Agency – EMA) and the FDA is paving the way for a new relationship leading to a better use of inspection resources.

The new initiative, starting in January 2012, should enable the authorities in the European Economic Area (EEA) and the US to rely on the results of inspections performed in each other’s territories. This should allow at least some inspections to be deferred or waived completely.

Read more details here – www.gmptrainingsystems.com/resources
Click on FDA Resources

www.GMPTrainingSystems.com

Serving 1983 clients since 1989

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

Validation Boot Camp
Feb 14 – 15 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

Outsourcing Boot Camp
Mar 13 – 14 Philadelphia, PA

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

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

Environmental Monitoring: Getting It Right!
Jan 20

EU GMPs: Implications of New Format for QP Declaration for APIs
Jan 27

Unraveling the Mysteries of Process Validation: ASTM E2500 Consensus Standard and its Harmony with FDA’s New Guidance
Feb 3

Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Feb 10

FDA Inspections: What to Expect
Feb 17

FDA Inspections: How to Prepare
Feb 17

Please forward this to others in your organization who may benefit

Just before Christmas Ranbaxy Laboratories, Ltd. announced that it has signed a Consent Decree with the U.S. FDA to work towards compliance with GMP. The $500M set aside to cover liabilities and potential claims are more than twice last year’s profits.

Here’s the BIG impact.

Ranbaxy this month started selling its generic rival to Pfizer’s Lipitor cholesterol treatment – called Atorvastatin – in the US. It has a 180-day marketing exclusivity period that the export ban prevents it from fully exploiting, as it cannot produce the drug in the affected Indian plants.

Without the ban, Ranbaxy could have been expected to grab close to a 45 per cent market share of the drug in that initial period, an analyst said, but instead Bloomberg data showed it only managed 9 per cent.

GMP Tip

Following GMP Makes Good Business Sense. Ranbaxy is a classic example of the negative impact of not following GMP.

Read Ranbaxy’s announcement plus two news stories. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1982 clients since 1989

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

Validation Boot Camp
Feb 14 – 15 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

Outsourcing Boot Camp
Mar 13 – 14 Philadelphia, PA

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

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

Environmental Monitoring: Getting It Right!
Jan 20

EU GMPs: Implications of New Format for QP Declaration for APIs
Jan 27

Unraveling the Mysteries of Process Validation: ASTM E2500 Consensus Standard and its Harmony with FDA’s New Guidance
Feb 3

Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Feb 10

FDA Inspections: What to Expect
Feb 17

FDA Inspections: How to Prepare
Feb 17

Please forward this to others in your organization who may benefit

Ben Venue Laboratories, Inc. recently received an 11-page FDA-483 Observation Report. Among the findings was the following:

“Routine preventative maintenance activities are not performed at their scheduled intervals. As of 11/11/11, there were approximately 107 required preventative maintenance activities for GMP equipment past their scheduled due date. To be considered past due, the event must be greater than 30 days past scheduled due date.”

Read the entire FDA-483 report here – www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1979 clients since 1989

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

Validation Boot Camp
Feb 14 – 15 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

Outsourcing Boot Camp
Mar 13 – 14 Philadelphia, PA

Cleaning Validation Boot Camp
Apr 24 – 25 Philadelphia, PA

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

Environmental Monitoring: Getting It Right!
Jan 20

EU GMPs: Implications of New Format for QP Declaration for APIs
Jan 27

Unraveling the Mysteries of Process Validation: ASTM E2500 Consensus Standard and its Harmony with FDA’s New Guidance
Feb 3

Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
Feb 10

FDA Inspections: What to Expect
Feb 17

FDA Inspections: How to Prepare
Feb 17

Please forward this to others in your organization who may benefit

KV Pharmaceuticals has “substantial doubt” about its ability to “continue as a going concern,” according to a financial statement recently filed. The troubled drugmaker lists its 2009 manufacturing consent decree and items related to the decree among the chief causes of doubt.

In assessing KV’s current business status, management articulated the consent-decree-related causes imperiling company viability: suspension of product shipments, the unknown timing of FDA approvals allowing shipments to resume and the likelihood KV will have to seek additional capital to compensate for lost revenue. Exec thinking was further colored by the company’s fiscal 2010 net loss of almost $284 million, according to the filing.

Here’s what can happen when you don’t make GMP a Lifestyle in your company. The sad part is all the people who will lose their jobs if KV shuts down. Read the history of KV’s troubles. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1974 clients since 1989

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

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

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

Introduction to GMP: Orientation for New Employees
Dec 16

Please forward this to others in your organization who may benefit

The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies. This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.

Read FDA’s Press Release with more details. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1971 clients since 1989

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

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

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

Introduction to GMP: Orientation for New Employees
Dec 16

Please forward this to others in your organization who may benefit

Merck plead guilty to a criminal charge over the marketing of Vioxx and has agreed to pay a $950 million settlement.

The company plead guilty to one misdemeanor count of illegally introducing Vioxx as a rheumatoid arthritis treatment before the Food and Drug Administration approved if for that purpose in 2002.

“When a pharmaceutical company ignores FDA rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients,” assistant attorney general of the Justice Department’s civil division Tony West said in a statement. Vioxx was pulled from the market in 2004 because evidence showed that it posed a substantial heart risk. By that time, approximately 25 million patients had taken the drug.

Merck agreed to pay $426 million to the federal government and $202 million to state Medicaid agencies to settle civil claims that the illegal marketing led doctors to prescribe and bill the government for the drug.

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

www.GMPTrainingSystems.com

Serving 1969 clients since 1989

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

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

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

Proven Steps to Reducing Waste in Process Validation
Dec 2

Introduction to GMP: Orientation for New Employees
Dec 16

Please forward this to others in your organization who may benefit

Can FDA mandate a recall of drug products?

Do manufacturers of OTC products have to report quality defects to FDA?

Read the answers to these and other related questions. Go to: www.gmptrainingsystems.com/resources
Click on Timely Resource Articles

www.GMPTrainingSystems.com

Serving 1966 clients since 1989

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

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

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

Proven Steps to Reducing Waste in Process Validation
Dec 2

Introduction to GMP: Orientation for New Employees
Dec 16

Please forward this to others in your organization who may benefit

FDA recently updated their requirements for reporting Adverse Events for Dietary Supplements. Download a copy here. www.gmptrainingsystems.com/resources
Click on cGMP for Dietary Supplements

www.GMPTrainingSystems.com

Serving 1963 clients since 1989

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

Validation Boot Camp
Feb 15 – 16 Philadelphia, PA

GMP Boot Camp – Fundamentals of GMP and QSR
Mar 7 – 8 Anaheim/Newport Beach, CA

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

ASTM E2500 Consensus Standard: An Overview of a New Approach to Validation
Nov 18

Proven Steps to Reducing Waste in Process Validation
Dec 2

Introduction to GMP: Orientation for New Employees
Dec 16

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