Issue of the Month
As FDA Implements a Risk-based Approach to Pharmaceutical cGMPs

After a long career in this industry, I find this to be a most exciting time to be involved in regulatory compliance for pharmaceuticals. There is a lot going on as the Food and Drug Administrative moves to implement a more risk-based approach to the regulation of pharmaceuticals.

As of January 1, 2011, for example, FDA joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S). This is a cooperative arrangement among international health authorities whose purpose includes leading the international development, implementation, and maintenance of harmonized cGMP standards and quality systems of worldwide pharmaceutical inspectorates. Looking ahead, I believe the agency’s membership of this group may lead to more joint inspections among international inspectorates as well as increased acceptance of member inspections.

Of more immediate importance for FDA’s cGMP efforts and for the pharma sector are the three revised guidance documents: ICH Q8 (Pharmaceutical Development, I, II); Q9 (Quality Risk Management); and Q10 (Pharmaceutical Quality Systems). These guidances for the development of new pharmaceutical products form a basis for the expectations of regulatory authorities regarding the control of the pharmaceutical product lifecycle going forward.

The ICH Q8 guide is designed to provide guidance on the information required to be submitted in Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. However, it is also useful as a source of information on the expectations of regulatory authorities regarding pharmaceutical products. The document provides guidance on how to develop a comprehensive scientific understanding of the drug process and product and it is useful for regulatory reviewers and inspectors. It is based on the principle that quality cannot be tested into a product but should be built in by design.

The ICH Q9 Quality Risk Management guide provides a systematic approach to quality risk management for the manufacture and control of pharmaceutical products throughout their lifecycle. It provides specific guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both the regulators and industry, regarding the quality of drug substances and products throughout their lifecycle.

The ICH Q10 Pharmaceutical Quality System guide describes a comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice regulations, and complements ICH Q8 and ICHQ9. The guidance is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.

In May of 2010, FDA issued a revised compliance program for the new drug pre-approval inspection program--the first since 1994. Although the program is written for the agency’s staff, it also provides useful guidance to industry. Significant changes in the revised program include the new risk based approach, as well as updated priority pre-approval inspection criteria.

The program explains that the type and depth of a Pre-Approval Inspection (PAI) depend on the PAI’s objectives. And what is covered in an inspection/audit will depend on the reason for the inspection. The three primary PAI objectives are to assess the facility’s readiness for cGMP manufacture, conformance to application, and data integrity. The program also calls for enhanced internal collaboration between the Center and the agency’s field offices, and international collaboration.

The ICH Guidance Documents (ICH Q8, ICH Q9 and ICH Q10) and the Pre-Approval Inspections Compliance Program are available on our EAS-e-Docs page.

As the agency evolves toward a more risk-based program, we will all—regulators and regulated—need to adjust to the new environment.

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FSMA Perspective
How Will the FSMA Impact Certification for Imported Foods?

Section 307 of the Food Safety Modernization Act requires the Food Drug Administration to introduce third-party certifications for foreign facilities that seek eligibility under a new Voluntary Qualified Importer Program, as well as for certain high-risk food imports.

Some of the new requirements for imported foods have their foundations in the November 2007 “Action Plan for Import Safety” published by the Interagency Working Group on Import Safety. This group was initially chartered, in part, as a result of several incidents with safety issues in imported products.

For example, on March 15, 2007, FDA learned that certain pet foods were sickening and killing cats and dogs. FDA found contaminants in vegetable proteins imported into the United States from China and used as ingredients in pet food. A portion of the tainted pet food was used to produce farm animal feed and fish feed. FDA and the U.S. Department of Agriculture discovered that some animals that ate the tainted feed had been processed into human food. As a result of FDA and USDA's comprehensive investigation, on February 6, 2008, FDA announced that two Chinese nationals and the businesses they operate, along with a U.S. company and its president and chief executive officer, were indicted by a federal grand jury for their roles in a scheme to import products purported to be wheat gluten into the United States that were contaminated with melamine.

Additional issues in the years preceding the 2007 working group efforts included chloramphenicol (an antibiotic unapproved for food) in imported honey, drugs in aquaculture-raised seafood and several disease outbreaks associated with imported cantaloupes and other produce.

The recommendations of the working group included such items as:

• Certification: Verify compliance of foreign producers with U.S. safety and security standards through certification.
• Good Importer Practices: Promote Good Importer Practices.

These are carried over in principle in the FSMA provisions.

The goal of the voluntary qualified importer program, described in Section 302 of the act, is to expedite food imports for those items that meet the voluntary standards. The agency has 18 months to issue a guidance document describing how the program will work. To be eligible to participate, an importer must be importing food from a facility that has been certified by an accredited third-party auditor. And the agency is required to reevaluate participating importers at least once every three years.

Also under the new law, FDA is required to establish, within two years, a system for accrediting bodies that accredit third-party auditors to certify foreign facilities.

In order to best be prepared and to position yourself for the new voluntary program and import requirements, it is essential to maintain a contemporary knowledge of the developments related to these provisions. It also may be advantageous to evaluate any existing third party audits that your firm is engaged in, either as a supplier specification or as a customer requirement, to understand the focus of those audits, and then to engage in planning for a shift or supplemental focus on regulatory compliance. EAS can assist in these efforts.

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Who's Who at EAS
Meet EAS Senior Consultant Robert Snell

Robert Snell joined EAS in March 2008 as a senior consultant, having previously served as a regulatory consultant with AAC Consulting Group since his retirement from the Food and Drug Administration after a 42-year career.

Mr. Snell has a broad FDA background, with emphasis on pharmaceutical consulting, assisting firms with audits, NDA’s, SOP’s, and compliance with 21 CFR 210 and 211.

In his last seven years with FDA, he was a compliance officer, working primarily with human and animal drugs. He also reviewed food and dietary supplement labels and labeling. His other duties included directing investigators in drug inspections.

An accomplished research chemist, Mr. Snell developed analytical procedures for chemicals leached for medical devices composed of materials containing phthalates, using various chromatography methods. The methods made use of gas chromatography, gas chromatography/mass spectrometry, high pressure chromatography, infrared, visible, and ultraviolet spectrometry, and thin layer chromatography. He presented the results of his research in peer-reviewed journals and at national symposia.

Earlier in his agency career, he served as a supervisory chemist and a bench chemist, directing and performing sampling of foods for composition, filth, residues, decomposition, and trace metals. In addition, he sampled drugs for active ingredients, degradation products, dissolution, and release profiles; medicated feeds for active ingredients; color analysis in cosmetics. As a supervisory chemist, he directed the quality control procedures used in his laboratory and reviewed all work before it left the laboratory.

“Bob Snell is a key member of our consulting team,” says EAS President Ed Steele. “With his wide-ranging FDA experience, he is a valuable asset for all our clients.”

EAS Welcomes Janice Gardner as a Senior Consultant

Honolulu-based Janice Gardner is the latest addition to the growing team of EAS senior consultants specializing in the food sector. A former FDA consumer safety officer and investigator and a registered sanitarian, she has more than 20 years of experience in food safety and regulatory compliance, including regulatory audits of food processors, retail food establishments and airline caterers.

Since leaving the federal agency in August 2010 after more than a decade of service, she has been a technical consultant to food industries including a major cruise line, the airline industry, and food preparation and manufacturing firms in Hawaii and the Pacific Region. Her areas of specialty include in-flight service, retail food safety, and seafood HACCP.

Ms. Gardner trained FDA investigators and other government agencies in foodborne disease control and outbreak management. At FDA, she was the lead investigator on multiple foodborne outbreaks on cruise ships and airline catering kitchens. She also trained state and local health officials in the FDA model Food Code, and regulatory food audit procedures.

From 1993 through 1999, she was a senior sanitarian with the Wisconsin Department of Health and Family Services, where she conducted retail food audits and reviewed plans for food preparation facilities.

She received numerous FDA awards including the Outstanding Service Award for activities related to outbreak investigations.

“Jan is a valuable new addition to our food consulting division,” says EAS President Ed Steele. “Her expertise in food audits and training will be in great demand as FDA implements the Food Safety Modernization Act.”

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What's New on FDA's Website
January Updates

Listed below are links to new additions to the FDA website for the month of January, 2011. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

• Fourth FDA orphan drug designation workshop scheduled for Feb. 28 - March 1, 2011 January 27, 2011


• FDA review indicates possible association between breast implants and a rare cancer January 26, 2011


• FDA approves Viibryd to treat major depressive disorder January 21, 2011


• Maine seafood processor enters into consent decree with FDA January 20, 2011


• FDA to improve most common review path for medical devices January 19, 2011


• FDA Approves Head Lice Treatment for Children and Adults January 18, 2011


• Federal government obtains permanent injunction against Deltex Pharmaceuticals Inc. January 18, 2011


• FDA seeks to halt processing, distribution at New York juice company January 13, 2011


• FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings January 13, 2011


• U.S. Marshals seize dental devices from Florida manufacturer January 13, 2011


• FDA approves opioid analgesic to help cancer patients manage pain January 7, 2011


• FDA warns public of continued extortion scam by FDA impersonators January 7, 2011


• FDA inspects retailers in Miss.; issues warning letters for illegal tobacco sales to minors January 7, 2011


• FDA launches website to help regulated industries save time, resources January 5, 2011


• FDA to require substantial equivalence reviews for new tobacco products January 4, 2011

• Feed Manufacturer Issues Limited Voluntary Recall of a Horse Feed Product Distributed in California, Nevada, and Oregon January 28, 2011


• Publix Issues Voluntary Recall on Ice Cream Containing Undeclared Allergen January 28, 2011


• MERRICK PET CARE RECALLS JR TEXAS TAFFY PET TREAT (ITEM # 27077, ALL LOTS UP TO AND INCLUDING 10364) BECAUSE OF POSSIBLE SALMONELLA HEALTH RISK January 28, 2011


• Undeclared Soy in “Mooney’s Kentucky Bourbon Cheese” and “Valumarket’s Beer Cheese Spread" January 28, 2011


• Sabor Farms Recalls Four Brands Of Cilantro Because Of Possible Health Risk January 28, 2011


• KEEBLER ISSUES ALLERGY ALERT ON MISLABELED 8-COUNT CARTONS OF FUDGE SHOPPE® JUMBO FUDGE STICKS SOLD AT CONVENIENCE STORES January 27, 2011


• Candy Dynamics Expands Recall To All Toxic Waste® Brand Nuclear Sludge® Products All Flavors And All Sizes January 27, 2011


• PEEKAY INTERNATIONAL INC. ISSUES ALLERGY ALERT ON UNDECLARED SULFITES IN SWAN GOLDEN RAISINS January 26, 2011


• PFIZER INC. AND PROGENICS ALERT PHYSICIANS AND PATIENTS TO INFORMATION RELATED TO TRIAD GROUP ALCOHOL PREP PRODUCTS INCLUDED IN U.S. RELISTOR KIT PACKAGING January 26, 2011


• State Garden, Inc. Announces Voluntary Recall Of Certain Salad Mixes Due To Possible Health Risk January 25, 2011


• Important information for ARIXTRA® Starter Kit patients regarding Triad Group’s alcohol prep products January 24, 2011


• Ian's Voluntarily Recalls Two Products Due To Risk Of Contamination January 24, 2011


• Pretzels. Inc. Issues Allergy Alert On Undeclared Milk In Better Made Brand Corn Pops January 21, 2011


• Hawaii Business Group Incorporated, Barb’s Favorite Recipes, and Ohana Seafoods Recall Barb’s Local Style Black Bean Sauce and Ohana Flavors Black Bean Sauce Because of Possible Health Risk January 20, 2011


• Mama Rose's Gourmet Foods Recalls Cilantro Con Queso, Garlic Con Queso, Viper Venom Con Queso and Hopi Corn Salsa Because of Possible Health Risk January 20, 2011


• Important Information for Betaseron® (interferon beta 1-b) Consumers Regarding Triad Group’s Alcohol Prep Products January 20, 2011


• King & Prince Seafood Issues Voluntary Recall Notice On Breaded Calamari Products January 20, 2011


• Barrel O’ Fun Snack Foods Co. Issues Allergen Alert on Undeclared Milk Protein in Valu Time Salt & Vinegar Potato Chips January 19, 2011


• Rich Products Corporation announces nationwide voluntary recall of Sonny’s Barbecue Deep Deveined Shrimp January 19, 2011


• Kanec USA, Inc. Issues a Voluntary Recall of Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men Male Enhancement Herbal Supplement Capsules Marketed as Dietary Supplements January 18, 2011


• McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products January 14, 2011


• Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (Expanded Recall to All “Best By” Dates ending in 2012) January 14, 2011


• Candy Dynamics Recalls Toxic Waste® brand Nuclear Sludge® Chew Bars all flavors -- Net wt. 0.7 oz (20 g) package January 13, 2011


• Genentech Informs Customers Of Important Information About Triad Group's Alcohol Prep Pads January 13, 2011


• MS Fish Corp Issues Alert On Listeria In Ossie’s Schmaltz Herring January 12, 2011


• Barry Callebaut USA LLC Issues Allergen Alert on Potential Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips January 12, 2011


• Important Information for Extavia® (interferon beta 1-b) Patients Regarding Triad Group's Alcohol Prep Products January 10, 2011


• Surtex Foods Recalls “Oaxaca String Cheese La Original” Because Of Possible Health Risk January 10, 2011


• La Placita Botanas Mexicanas, Inc. Recalls Wheat Snacks with Chile, Potato Chips with Chile, and Corn Churritos with Chile Because of Possible Contamination with Salmonella January 7, 2011


• Teva Pharmaceuticals, U.S.A issues a voluntary nationwide recall of Metronidazole Tablets USP, 250mg Due to Low Weight Tablets January 6, 2011


• Boncheff Greenhouses, Inc. Recalls For Wegmans Food Markets, Inc., Budwey Markets, Wades Market, Cuba Giant Food Market, And Hegedorn’s Cilantro, Curly Parsley, And Italian Parsley Because Of A Possible Health Risk. January 5, 2011


• Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination January 5, 2011


• SPROUTERS NORTHWEST, INC. RECALLS CLOVER SPROUTS AND CLOVER SPROUT MIXES BECAUSE OF POSSIBLE HEALTH RISK January 3, 2011

• January 19, 2011
• January 12, 2011
• January 5, 2011

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

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EAS in Action

EAS Launches EAS-e-Docs as Stand-Alone Publication

EAS-e-Docs, our free service offering selected documents we believe can help companies comply with FDA's laws and regulations, is now a separate, monthly service with its own email alerts. In addition, document selection and delivery has been simplified. The first stand-alone issue was sent mid-January. We hope you find this service as an “easy” way to get copies of regulatory documents of interest.

EAS can locate other hard-to-find FDA documents for a document retrieval fee. Documents retrieved through a Freedom of Information Act request may incur FDA copy and research charges. For details, contact Chris Celeste, Director of Regulatory Information and Submissions, email cceleste@easconsultinggroup.com, telephone: (301) 294-1771.

Hoadley and Cirotta Help Make FDLI Food Week a Success Despite Winter Storm

Despite a winter storm that hit Washington D.C., during FDLI’s Food Week 2011, January 24-27, the event went on as planned. EAS was represented by Senior Consultant Dr. James Hoadley, a former senior regulatory scientist at FDA, who discussed claims issues at the Food Labeling, Advertising and Marketing Conference, January 26, and by Vice President of Pharmaceutical, Dietary Supplement and Tobacco Services, Dean Cirotta, who spoke at the Dietary Supplement 2011 Conference, January 27.

CHPA Advanced OTC Drug GMP Training Seminar Sold Out Quickly

Registrations were quickly sold for an upcoming Consumer Health Products Association (CHPA) Advanced OTC Drug GMP Seminar. This seminar conducted for CHPA members by EAS will be held at the association’s headquarters in Washington, D.C., February 17-18. EAS instructors for the two-day seminar will include: Dean Cirotta, vice president of pharmaceutical, dietary supplement and tobacco services; Tony Celeste, senior advisor; and Chris Celeste, director of regulatory information and submissions. The members-only event is limited to 40 participants.

Registrations are Open for Next Food Labeling Compliance Review Seminar

We anticipate increased demand for our next Food Labeling Compliance Seminar, which will be held at the EAS headquarters in Alexandria, Va., March 29-30. To be sure of securing a place, we encourage participants to sign up early for this event.

Here is an opportunity to:

• Learn FDA food labeling requirements from labeling experts who helped to develop and implement the current regulations and have reviewed hundreds of labels for the industry.
• Learn of hot issues that have triggered recent FDA warning letters.
• Apply learning in practical work sessions.
• Have your specific issues addressed and discussed in a casual, interactive learning environment.

The seminar offers a quick way to learn about the issues that triggered recent FDA warning letters and to get up to date on FDA food labeling requirements, through instruction from labeling experts who helped to develop the regulations. The seminar includes interactive work sessions.

Instructors for this popular seminar will be:

• EAS Vice President Elizabeth (Betty) Campbell, who served as head of FDA's Office of Food Labeling before becoming a labeling consultant in 1999. She played a key role in writing and implementing the Nutrition Labeling and Education Act (NLEA) regulations;
• EAS Senior Consultant James E. Hoadley, a former senior regulatory scientist at FDA; and
• EAS Consultant Gisela Leon, who has an extensive background in U.S., European and other international labeling requirements.

Register to attend at www.easconsultinggroup.com. If you have questions, contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

EAS Announces Dates for Dietary Supplement GMP and Laboratories Seminars

EAS has scheduled two new dietary supplement training opportunities.

The next Dietary Supplement GMP Seminar will take place April 12-13, 2011 at the EAS training facility in Alexandria, Va. This intensive training program will provide all the information needed to comply with the Food and Drug Administration’s final GMP rule, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

In addition, EAS has scheduled a separate two-day event titled Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar, April 14-15, 2011, at the EAS training facility in Alexandria, Va. FDA trend data over the past several years has shown that deficiencies in laboratory controls are among the most frequently cited observations during inspections of pharmaceutical companies. This two day course will provide you with the knowledge and skills for evaluating, auditing, managing, and improving the CGMP compliance of your in-house and/or contract laboratory. You will be provided with examples of lab CGMP deficiencies from FDA-483 drug citations and recommendations for practices and procedures to ensure and demonstrate CGMP compliance.

Register to attend at www.easconsultinggroup.com. If you have questions, contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

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Upcoming Events

Food Labeling Compliance Review Seminar
March 29-30, 2011
Alexandria, Va.

Dietary Supplement GMP Seminar
April 12-13, 2011
Alexandria, Va.

Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar
April 14-15, 2011
Alexandria, Va.

Supply Side East
May 2-4, 2011
Secaucus, N.J.

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Order Publications and Regulatory Tools

	EAS Labeling Type Size Guide A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.	$ 9.00
	Dietary Supplement GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	Pharmaceutical GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 210, 211 and 11 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	Dietary Supplement Labeling Compliance Review, 3rd edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell Hardbound book	$ 194.99
	Food Labeling Compliance Review, 4th edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell. Hardbound book and CD	$ 229.00 / set
To purchase any items listed above download our

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