GMP GMP. What is it and why do we need it? Dennis Reiswig. The FDA. USP & NF History. Regulatory Definitions. (Good Manufacturing Practices)

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1 2007 Intertanko GMP Presentation GMP What is it and why do we need it? Dennis Reiswig Sr. Quality Specialist The Dow Chemical Company Regulatory Definitions GMP CFR FDA (Good Manufacturing Practices) (Code of Federal Regulations) (Food and Drug Administration) Federal agency responsible for ensuring that foods and drugs are safe. USP/NF (United State Pharmacopeia / National Formulary) IPEC EXCIPIENT (The international Pharmaceutical Excipients Council) IPEC America - IPEC Europe - IPEC Japan (Non-Active ingredient in a drug formulation) Dow GMP Regulated Products What are USP & NF? Acetone NF Carbowax NF Ethanol USP/EP Ethocel NF Isopropyl Alcohol USP Methocel USP Methylene Chloride NF Optim Glycerine 99.7% USP/EP Propylene Glycol USP/EP Versene CA & NA USP The United States Pharmacopeia and National Formulary (USP NF) a book of public pharmacopeial specifications and methods It contains specifications for: medicines dosage forms drug substances excipients medical devices and dietary supplements USP & NF History The FDA USP = United States Pharmacopeia - First published in Recognized by Congress in Standard Reference for Physicians NF = National Formulary - First published in Standard Guide for Preparing Medicines - NF Combined with USP in 1980 FDA (Food and Drug Administration) Federal agency responsible for ensuring that foods and drugs are safe A single chemist in the USDA (United States Department of Agriculture) Currently - Over 10,000 employees - $1billion+ budget - Overseeing $1 trillion dollars in products annually 1

2 FDA Audits FDA AUDITS are a SERIOUS MATTER The FDA has Legal Authority to: Obtain a Search Warrant Arrive Unannounced Take Pictures Obtain Copies of Records Examine Confidential Info. Obtain Samples Issue Fines & Criminal Charges The FDA Investigator The FDA Investigator inspects for compliance against GMPs Any facility that manufactures or repackages a GMP regulated product is considered a Manufacturing Site and is subject to an audit by the FDA. The FDA Investigator may declare a product adulterated if its manufacturing, packaging, or storage do not conform to GMPs. * *Paraphrased from Section. 501 Federal Food Drug and Cosmetic Act-1962 Amendment Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) Why follow GMP requirements? The failure to comply with any regulation set forth in this part (210) and in parts 211 through 229 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 510(a)(2)(b) of the (FFD&C) Act and such drug, as well as the person who is responsible for the failure to comply shall be subject to regulatory action. Consequences of Poor GMP Schering Plough - June, 2002 $500 M Fine Wyeth Ayerst - Oct, 2000 $30 M Fine Abbott Labs - Nov, 1999 $100 M Fine Training Organization Documentation Process Control Building and Facilities Equipment Inspection & Testing Labeling Sanitation Internal Audits Training - Anyone involved in the manufacture, packaging, storage, and/or distribution of a regulated product must receive documented training each year. Documentation - All procedures used in the manufacture, packaging, storage, and/or distribution must be documented. 2

3 Buildings and Facilities - Buildings and Equipment used in the manufacture, packaging, storage, and/or distribution must have a documented housekeeping and pest control procedures. Sanitation - Personnel should practice good sanitation and health habits. All personnel should be instructed to report to supervisory personnel any health conditions that may have an adverse effect on excipients. Labeling - There must be a documented label accountability program. Internal Audits - There must be a documented internal auditing system designed to evaluate GMP compliance. Organization - There must be a designated Quality Responsible person who has responsibility for GMP Compliance. CUSTOMER EXPECTATIONS Product Purity - Meets Specifications Product Consistency - Minimal Variations Meets Regulations - It s the Law PLEASE REMEMBER! THE PRODUCTS WE MAKE, DISTRIBUTE & SELL END UP IN THE PRODUCTS WE EAT, DRINK & USE EVERYDAY! Personal Care Applications Food Applications shampoos soaps conditioners toothpaste mouthwashes shaving creams hair sprays lotions cosmetics, deodorants perfumes colognes fruit bars cereals dried fruits jams & jellies sausages soft drinks cookies candy bars frozen deserts chewing gum 3

4 Drug Applications What would happen cough syrups injectable drugs intravenous solutions tablet coatings & binders eye, ear & nose drops wound and bandage dressings vaginal creams suppositories elixir type medications 100 ml Typical Prescription Solution 50 % Typical PG USP/EP Content 20 $ Typical Prescription Price (very conservative) 55 gal drum > $80,000 Tank Truck > $7,000,000 Rail Car > $35,000,000 What would happen What can happen when GMP is not followed: World Health Organization announced on May 15, 1998: More than 500 deaths in the last 15 years have been caused by contaminated pharmaceutical excipients. 500 DEATHS IN LAST 15 YEARS What can happen when GMP is not followed: 2006 Panama (41 people killed) - DEG contaminated glycerine in government cough syrup China (11 people killed) - DEG mislabeled as PGUSP used in Armillarisini A India 1998 (33 children dead) Haiti 1995/96 (80 children dead) Bangladesh (51 deaths) Argentina 1992 ( 22 deaths) South Africa 1972 (7 children dead) United States 1930 s (105 deaths) We can all make a difference! More Information? Our key concern is to avoid the possibility of contamination, mix-ups, and errors. Our defenses include: good housekeeping pest control proper maintenance training personal hygiene well written procedures and our ability to do the job right the first time, every time Marine Handling Guidelines 4

5 Why are GMPs Important? 5