Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Points (HACCP) are both systems intended to ensure the safety of food, chemicals and pharmaceuticals. GMP is the “first step” to food safety, as a series of principles to be fulfilled to ensure that products meet legal prerequisites for safety and quality. It can be one of the components of HACCP, which is a systematic approach to production that is designed to prevent hazards from occurring. HACCP has been increasingly applied to non-food industries, such as cosmetics and pharmaceuticals.
GMP is used in the US, and enforced by the US FDA. The World Health Organization version of GMP is used in over 100 other countries, mostly in the developing world. Similar GMPs are found in the EU, Australia, Canada, Japan, Singapore, and the Philippines.
HACCP is used in the US, and is enforced by the FDA (for seafood and juice) and USDA (for meat). It is also used in the UK (regulated by the Food Standards Agency), EU countries, Australia, Canada, and others.
GMP applies to pharmaceutical and medical companies, as well as to food manufacturing. A different set of GMP requirements also applies to dietary supplements in the US.
HACCP applies to any organization involved directly or indirectly in the food chain and pharmaceutical industry, such as farms, fisheries and dairies, processors of meat, bread manufacturers, food service providers such as restaurants and hospitals, and manufacturers of prescription and non-prescription drugs.
The GMP guidelines follow several basic principles. Manufacturing processes must be clearly defined and controlled, instructions much be written in clear language, operators must be trained to carry out and document procedures, records must be made, the distribution of drugs must minimize any risk to their quality, there must be a system for recalling any batch of drugs, and complaints must be examined to prevent re-occurrence.
HACCP is built around seven principles:
- Conduct a hazard analysis
- Identify critical control points
- Establish critical limits for each critical point
- Establish critical control point monitoring requirements
- Establish corrective actions
- Establish procedures for ensuring the HACCP system is working as intended.
- Establish record keeping procedures.
These videos throw light on the rigor and practices of the two systems:
The basics of HACCP:
GMP regulations are regulated by the U.S. FDA. The intent is to protect consumers from purchasing goods that are not effective or dangerous to consumers' health and well-being. In order to ensure products have consistent and controlled production according to quality standards, companies must fulfill several requirements to get GMP certification. WHO issues a product certificate when the product is under consideration for a product license that will authorize its importation and sale. A renewal, extension, variation or review of such a license requires administrative action. Other documents needed are statement of licensing status (TRS 823, 863), and batch certificate (TRS 823, 863) for WHO GMP certification.
HACCP certification is required in the UK, and involves filling out a questionnaire and showing during an assessment that the quality management system has been in place for at least three months. In the US, an individual can become certified as a specialist in HACCP, qualifying them to audit and evaluate HACCP systems. In order to receive this qualification, food-safety professionals must pass the Certified HACCP Auditor Exam, offered by the American Society for Qualification. Individuals must recertify every three years.
GMP guidelines are not instructions that companies must follow, but a series of principles that must be fulfilled. It is up to each individual company to decide how they will be put into practice.
Compliance with HACCP is defined as meeting all regulatory requirements, including monitoring, verification, record-keeping, corrective actions and reassessment.
Penalties for Non-Compliance
In the US, a drug is considered adulterated if it does not meet GMP specifications. The FDA can then order the seizure of the adulterated drug, and will take measures to force the company to improve GMP, such as hiring outside experts, writing new procedures and conducting extensive training. The FDA can also bring criminal cases against non-complying companies, including fines and jail time. However, the FDA cannot force the company to withdraw the drug from the market.
If noncompliance to HACCP occurs, the company is expected to take immediate action. However, if the company deviates from its own defined critical limit, it is required to take action. A non-compliance report must be filed.
The World Health Organization wesbite has information on GMP
The Federal Register is a resource for companies implementing GMP.
The FDA has a guide to implementing HACCP
USDA has a guide to defining noncompliance.
- Wikipedia: Good manufacturing practice
- Facts About Current Good Manufacturing Practices - US FDA
- Current GMPs - pharma.about.com
- What is HACCP? - nqa.com
- HACCP Principles & Application Guidelines - fda.gov
- HACCP Certification - Wise Geek
- Traditional Food in Combating Foodborne Pathogens - www.mf.uni
- What is HACCP? - FAQ agriculture.gov.sk.ca