The Most Important Compliance Best Practices You Need to Know

Current Good Manufacturing Practices are regulations published by FDA to provide criteria for complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act). cGMP requires all drug products that are developed and produced are safe, properly identified, of the correct quality, strength, and purity. The word “current” is used in conjunction with GMP as technologies are constantly evolving and so do the requirements to attain GMP compliance. Even though cGMP regulations have been in place since long time, the large number of 483's and warning letters demonstrate that companies have problems with implementation. The GMP regulations are codified in 21 CFR 210-211.

Recent events have shown that in an increasingly globalized food production environment, food safety has emerged as a vital public issue. Food manufacturers are increasingly under scrutiny both from governments and consumers regarding their production methods, quality practices and commitment to product safety. One of the cornerstones of a strong food safety management system is HACCP. The seventh HACCP principle focuses on setting up record keeping and documentation procedures to ensure compliance with food safety regulatory requirements. For the successful implementation of HACCP, appropriate documentation and records must be kept and be readily available. This article describes some of the record keeping best practices that will help food manufacturers ensure compliance with HACCP requirements related to food safety management systems.

The dietary supplement market has witnessed huge growth in the last decade and this boom in sales been accompanied by increased regulatory scrutiny. Both the government and federal agencies are concerned about the dangers posed to public health by misleading claims and labels on these products. The FDA is cracking down on the health claims being put forward by dietary supplement makers about their products. The agency is planning to widen its surveillance of the market to detect such claims.This white paper details how dietary supplements are currently regulated and six labeling best practices that dietary supplement manufacturer should follow in order to ensure compliance.

Recent events have shown that in an increasingly globalized food production environment, food safety has emerged as a vital public issue. Food manufacturers are increasingly under scrutiny both from governments and consumers regarding their production methods, quality practices and commitment to product safety. One of the cornerstones of a strong food safety management system is HACCP. It is a systematic approach to the identification, evaluation, and control of food safety hazards based on seven core principles. The seventh HACCP principle focuses on setting up record keeping and documentation procedures to ensure compliance with food safety regulatory requirements. For the successful implementation of HACCP, appropriate documentation and records must be kept and be readily available. This White Paper describes some of the record keeping best practices that will help food manufacturers ensure compliance with HACCP requirements related to food safety management systems.

In this article, Melvin Dionne, a pharmacist-consultant, provides a high level overview of Canadian regulations governing the licensing and manufacturing of natural health products.

Marion Nestle, author of Food Politics: How the Food Industry Influences Nutrition and Health,  writes about the FDA's recently published food safety rules.

Republished from www.foodpolitics.com with kind permission of the author.

Marion Nestle, author of Food Politics: How the Food Industry Influences Nutrition and Health,  writes about how the horsemeat scandal in Europe is really a case study in food politics and the politics of cultural identity.

Republished from www.foodpolitics.com with kind permission of the author.

Canada is one of the few countries worldwide that has introduced and successfully implemented a regulatory framework for governing the sale and importation of natural health products (NHPs) to consumers. While the initial phase-in was met with disappointing review times and industry confusion over application requirements, the approval process has now become extremely efficient, with some types of NHP applications being approved in as little as 60 days. Sponsors wishing to receive product licences for their NHPs need simply to submit complete applications in proper format, and respond to any information requests within the given deadlines, in order to successfully register their products for sale in Canada.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 is an amendment to the Federal Food, Drug, and Cosmetic Act. It requires that manufacturers clearly identify on the labels of food if it contains an ingredient that is or contains protein derived from a "major food allergen" declare the presence of the allergen in the manner described by the law.

The School Food Safety Program is based on the Hazard Analysis and Critical Control Point Principles (HACCP) established by the Secretary of Agriculture, U.S Department of Agriculture (USDA). HACCP implemented a legislative provision requiring school food authorities participating in the National School Lunch Program (NSLP) or the School Breakfast Program (SBP) to develop a school food safety program for the preparation and service of school meals served to children. It enables schools to take systematic action to minimize or prevent the risk of food-borne illness among children participating in the either program.

The U.S Department of Agriculture, through its Food Safety and Inspection Service (FSIS) has established January 1, 2014, as the uniform compliance date for new meat and poultry product labeling regulations that are issued between January 1, 2011, and December 31, 2012.

Uniform compliance dates are periodically announced to minimize the economic impact of label changes.

Good Agricultural Practices (GAP) are a collection of principles applied to on-farm production and post-production processes, leading to safe and healthy food and non-food agricultural products, taking into account economical, social and environmental sustainability.

Sanitation becomes critical when it comes to food safety. Improper sanitation may result in reduces shelf life and losses due to spoilage. HACCP enforces sanitation to reign in the possible hazards – microbiological, chemical, & physical - in the food manufacturing environment.

Sanitation involves proper cleaning of the food plant, equipments, utensils, and structure. This kind of an effort requires a good team of sanitarians who can work the hours required and handle the conditions of work. Sanitation department becomes the most important department in food manufacturing.

• Hiring the right people
• Providing requisite training
• Providing proper safety gear for the employees
• Factors to be considered when developing a sanitation procedure
• Information on different food soils and their attributes
• Information on different chemicals, their use and associated hazards
• Considerations with regards to the water to be used for the procedure
• Different cleaning equipments
• Detailed cleaning process

Sanitation is a preventive and proactive process. For more details on how to implement a good sanitation procedure read on

Background: Food contamination incidents can attract serious media coverage for days. As a result, these stay on top of the mind of consumers. This free publicity can harm the brand of the manufacturer but mostly the producer at the bottom of the supply chain who takes the hit. Bouncing back from such an incident is possible, but calls for greater investment of time and resources. Smaller players may not be able to withstand such an effort.

Various government agencies are working to bring in regulations to avoid such incidents because the resulting hazards affect the masses. U. S. Government has agencies like

• Current Good Manufacturing Practices - cGMP
• Hazard Analysis and Critical Control Points - HACCP

Food Defense Program provides the safe guard for the people, products, customers, assets and the brand of an enterprise. It aids the company’s communication of its commitment to protect the consumer and others involved from intentional tampering.

How to develop a Food Defense Program?