Good Manufacturing Practices (cGMPs)

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every people.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).  cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.  This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.  This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.  This assures that drug products meet their quality standards.

The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.  The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.   Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.  Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards. 

It is important to note that cGMPs are minimum requirements.  Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards. 

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work.  While cGMPs require testing, testing alone is not adequate to ensure quality.  In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing.  Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step.  Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.

How does FDA determine if a company is complying with cGMP regulations?

FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations.  FDA also relies upon reports of potentially defective drug products from the public and the industry.   FDA will often use these reports to identify sites for which an inspection or investigation is needed.  Most companies that are inspected are found to be fully compliant with the cGMP regulations.

If a manufacturer is not following cGMPs, are drug products safe for use?

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law.   This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug. 

For consumers currently taking medicines from a company that was not following cGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health.  Consumers should seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with poor cGMPs are taken as a preventive measure because the manufacturing processes do not meet FDA’s regulatory standards.  By focusing on the procedures and processes used to make these drugs, FDA is working to ensure that drugs meet their quality standards and are safe and effective.   The impact of cGMP violations depends on the nature of those violations and on the specific drugs involved.  A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal.   Thus, FDA’s advice will be specific to the circumstances, and health care professionals are best able to balance risks and benefits and make the right decision for their patients.

What can FDA do to protect the public when there are cGMP violations?

If the failure to meet cGMPs results in the distribution of a defective drug, the company may subsequently recall that product.   This protects the public by removing these drugs from the market.  While FDA cannot force a company to recall a drug, companies will usually recall voluntarily or at FDA’s request.  If a company refuses to recall a drug, FDA can warn the public and could seize the drugs that are on the market.

Even if the drugs are not defective, FDA can bring a seizure or injunction case in court to address cGMP violations.  When FDA brings a seizure case, the agency asks the court for an order that allows federal officials to take possession of “adulterated” drugs and destroy them.  This enables FDA to immediately prevent a company from distributing those drugs to consumers.  When FDA brings an injunction case, FDA asks the court to order a company to stop violating cGMPs.  Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations, such as hiring outside experts, writing new procedures, and conducting extensive training of their employees.  FDA can also bring criminal cases because of cGMP violations, seeking fines and jail time.

 

Pharmaceutical Inspection Co-operation Scheme

 

PIC/S is a combination term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. PIC/S was established to harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries. PIC/S is also a body that even harmonized relation among regulatory authorities and governments. The present article helps in understanding the origin, purpose, objective, role and functions of PIC/S.

Origin and Purpose:

In 1995, PIC/S was established as a provision to streamline with long back established

Pharmaceutical Inspection Convention of 1970 with some flexibility. Initially, European

Commission is the body permitted to sign agreements with countries outside Europe. Since,

European Commission is not a member of Pharmaceutical Inspection Convention of 1970, there

was some incompatibility among European Law and PIC. This incompatibility did not allow EU

countries that were members of PIC to have agreement with countries that are seeking to join

PIC. This led to formation of a PIC Scheme that is a less formal, more flexible, with no legal

status that in turn brings understanding between health authorities. Thus PIC/S is a parallel

scheme of both Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme. PIC/S has brought understanding among health authorities and governments and led to joint execution of activities of PIC and PIC scheme.

History, Members of PIC and PIC/S:

Pharmaceutical Inspection Convention was established in 1970 by European Foreign TradeAssociation under the title “The Convention for the Mutual Recognition of Inspections in

Respect of the Manufacture of Pharmaceutical Products”. Initial ten members of EFTA i.e.

Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and

United Kingdom were later members of PIC. Membership of PIC was subsequently expanded to

include Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia. It was later

the PIC scheme established in 1995 that in turn led to PIC/S. Presently, 39 regulatory authorities are members and partners of PIC/S (Annexure A).

 

 

 

 

 

Objective of PIC and PIC/S:

The main objective is to harmonize Good Manufacturing Practice requirements, bring about uniform-mutual recognition inspections, educate and exchange information, among different countries and attain mutual confidence of drug regulatory authorities. The key issues like duplication of inspections, licensing procedures, expenditure and licensing can be overcome by one time procedures.

Role of PIC/S:

The role of PIC scheme is to safe guard public health by providing good quality medicines by bringing a harmonization in Good Manufacturing Practice among countries. To achieve this  harmonization, regular awareness along with training, sharing information and experience,implementing procedures to be followed relating to manufacture and quality control of medicinal products so that equivalent standards among countries can be implemented.

To meet the objective, PIC/S has to thoroughly assess the status of regulatory process of a drug regulatory authority of a country and make necessary changes if necessary in the protocols of manufacturing and quality control of drugs so as to harmonize Good Manufacturing Practice among the member countries.

Administrative Structure of PIC/S:

PIC/S is constituted with a permanent committee and executes meetings with representative of participating authorities. The meetings are held at least twice a year by the committee. The PIC/S committee is assisted by a secretariat in coordinating, documenting and implementing the objectives of PIC/S.

Functions of PIC/S Committee:

To meet the objectives of PIC/S in terms of harmonisation of GMP, the committee makes recommendations, update and improve GMP, promote cooperation relating to quality assurance of inspections and quality systems of inspectorate, educate the authorities by means of training and exchange of information and helps in bringing out new guidelines relating to manufacturing and quality control of medicinal products. The committee also assesses the system being practiced by a country for medicinal products in terms of manufacture, quality control along with protocols followed for corresponding regulatory inspections/inspectors and decides suggestions and changes necessary for the country to become a member of PIC/S.

Advantages with PIC/S:

PIC/S brings about an international harmonization among countries with relating to Good

Manufacturing Practice, quality maintenance systems of medicinal products. In addition to this,

implementation of high standards of quality along with mutual understanding among members is

achieved. PIC/S brings about a single network system relating to GMP of medicinal products

and helps member regulatory authorities in sharing, facilitating, recalling, concluding aspects

relating to manufacture, quality and inspection systems among inspectorates, pharmaceutical

industries. Aspects relating to duplication of inspections and other regulatory become cost

effective. PIC/S also brings about single window export facilitation to enhance marketing of the

medicinal products. As a whole, PIC/S brings about uniform licensing decisions among member

countries. Several countries like Colombia that is a non-PIC/S authority do accept GMP

certification from PIC/S member countries for import of the medicinal product which is a

benefit.

Difference between PIC Scheme and PIC:

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HACCP

 

Hazard Analysis and Critical Control Points (HACCP) is a systematic preventative approach to food safety that addresses physical, chemical and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points (CCP's) can be taken to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production and preparation processes. Today HACCP is being applied to industries other than food, such as cosmetics and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs from traditional "produce and test" quality assurance methods which are less successful and inappropriate for highly perishable foods. We offer a

 

variety of products to help you achieve HACCP/CCP standards.

 

The impetus behind modern HACCP programs first began as a natural extension of Good Manufacturing Practices (GMPs) that food companies had been using as a part of their normal operations. A system was needed that enabled the production of safe, nutritional products for use by NASA starting in the late 1950’s to feed future astronauts who would be separated from medical care for extended periods of time. Without medical intervention, a sick astronaut would prove a very large liability and could possibly result in the failure of entire missions. Food products could not be recalled or replaced in space.

 

Beginning in 1959, the Pillsbury company embarked on work with NASA to further develop a process stemming from ideas employed in engineering systems development know as Failure Mode & Effect Analysis (FMEA). Through the thorough analysis of production processes and identification of microbial hazards that were known to occur in the production establishment, Pillsbury and NASA identified the critical points in the process at which these hazards were likely introduced into product and therefore should be controlled.

 

The establishment of critical limits of specific mechanical or test parameters for control at those points, the validation of these prescribed steps by scientifically verifiable results, and the development of record keeping by which the processing establishment and the regulatory authority could monitor how well process control was working all culminated in what today is known as HACCP. In this way, an expensive or time consuming testing procedure is not required to guarantee the safety of each piece of food leaving an assembly line, but rather the entire process has been seamlessly integrated as a series of validated steps.

 

In 1971 the HACCP approach was presented at the first American National Conference for Food Protection. 1973 saw the US FDA apply HACCP to Low Acid Canned Foods Regulations, although if you read those regulations carefully, you will note that they never actually mention HACCP. From 1988 to the present day, HACCP principles have been promoted and incorporated into food safety legislation in many countries around the world.

 

Beginning in 1996, the United States Department of Agriculture (USDA) established a detailed Pathogen Reduction / Hazard Analysis of Critical Control Point (PR/HACCP) program under the Food Safety and Inspection Service (FSIS) to regulate the production of raw meat products by large scale facilities. There is currently no HACCP requirement in the US for food processors such as supermarket deli or butcher departments that purchase from certified producers.

 

The HACCP seven principles

 

Principle 1: Conduct a hazard analysis. – Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

 

Principle 2: Identify critical control points. – A Critical Control Point (CCP) is a point, step, or procedure in a food manufacturing process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

 

Principle 3: Establish critical limits for each critical control point. – A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

 

Principle 4: Establish critical control point monitoring requirements. – Monitoring activities are necessary to ensure that the process is under control at each critical control point. In the United States, the FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

 

Principle 5: Establish corrective actions. – These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

 

Principle 6: Establish procedures for ensuring the HACCP system is working as intended. – Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the production of a safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule.

 

Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification tasks to be performed by plant personnel. Verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as one of several verification activities.

 

Verification also includes 'validation' – the process of finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical limitations).

 

Principle 7: Establish record keeping procedures. – The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

 

The seven HACCP principles are included in the international standard ISO 22000 FSMS 2005. This standard is a complete food safety and quality  management system incorporating the elements of prerequisite programmes(GMP & SSOP),[HACCP and the quality management system, which together form an organization’s Total Quality Management system.

 

Halal

Halal ( means lawful or legal) is a term designating any object or an action which is permissible to use or engage in, according to Islamic law. The term is used to designate food seen as permissible according to Islamic law . The opposite of this word is haraam.

The terms halal and haraam are applied to many facets of life; and one of the most common uses of these terms is in reference to meat products, food contact materials, and pharmaceuticals. In Islam there are many things that are clearly halal or haram. There are also items which are not as clear, and for which further information is needed. Items that are not clear are called mashbooh, which means "questionable". 'Halal' means permissible. 'Haraam' means forbidden. The term 'halal' can, therefore, also be associated with other products such as halal mortgages  which omit the use of 'interest' which is 'haraam'.

In Islam, other forbidden items include pork and all its products; animals improperly slaughtere, alcoholic drinks, including all forms of intoxicants; carnivorous animals; birds of prey; and any food contaminated with any of these products.

Islam has laws regarding which foods can and cannot be eaten and also on the proper method of slaughtering an animal for consumption, known as dhabihah. However if there is no other food available then a Muslim is allowed to eat non-halal food.

If one is forced because there is no other choice, neither craving nor transgressing, there is no sin on him.

 Explicitly forbidden substancesA variety of substances are considered as harmful (haraam) for humans to consume and, therefore, forbidden as per various Quranic verses:

Pork,Blood,Animals slaughtered in the name of anyone but Allah. All that has been dedicated or offered in sacrifice to an idolatrous altar or saint or a person considered to be "divine",Carrion (carcasses of dead animals),An animal that has been strangled, beaten (to death), killed by a fall, gored (to death), savaged by a beast of prey (except by a human),Food over which Allah's name is not pronounced (or at least not in a name other than Allah)and Alcohol and other intoxicants

Halal food certification refers to the examination of food processes in its preparation, slaughtering, cleaning processing, handling, disinfecting, storing, transportation and management practices. The application of halal should apply to all stages of processing "from farm to table". Halal certification provides the following benefits:

1. Consumer confidence – it allows the consumers to make an informed choice of their purchase

2. Competitive advantage – manufacturers can use it as a marketing tool to secure bigger market share as halal   food is suitable for both Muslims and non-Muslims. At international level, it can enhance the marketability of the products especially in Muslim countries.

3. Quality – it indicates that the food p r o d u c t n o t o n l y f u l f i l s h a l a l requirements, but also strict hygiene practices

4. For the authority – it provides a mechanism to audit and monitor halal food.

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Compliance to Halal requirements

With the certification, manufacturers are obliged to act responsibly to maintain the halal stat us of the food they produce. Manufacturers must ensure during all phases of the production, the raw materials, equipment, tools and materials used must not be najs(filthy or polluted), mixed with any najs material or has been in contact with najs materials. The product and raw materials used must also be safe and will not cause harm to the health. Ensuring a product is halal is not only limited to the materials and ingredients used. Halal requirements cover all aspects of preparation, processing, packaging,distribution and all related processes. Any equipment found to be in contact or contaminated with non halal materials must be cleansed according to the Syariah requirements. In Halal food, cleanliness and hygiene is very closely related to food safety. This is an important prerequisite halal certification and the requirement covers personal hygiene, attire, equipment and working environment.

Employees’ Understanding on Halal requirements

All employees required to be trained to understand the halal concept, as well as their roles and responsibilities in ensuring the products are handled accordingly. Manufacturers are encouraged to establish a quality assurance unit to monitor all requirements of halal are complied with at all time, especially in critical areas such as procurement. The unit should also ensure that any non-compliance is immediately rectified.

The halal food issue is a sensitive and serious matter to the Muslims. Halal certification will help boost the confidence of the Muslim consumers that the food and product they purchase are not only halal but also hygienic and safe.

List of common food ingredients and additives

 

Substance

Description

First Opinion

Second Opinion

Acetic Acid

Occurs naturally in plant juices and can be prepared synthetically and can be obtained from animal tissues.

Halal if it is made from plant sources or synthetically. If it is made from animal tissues, then it will not be Halal

Halal and Suitable for Muslim to consume. Acetic acid from animal source is not available in markets.

Adipic Acid

Occurs naturally in beets and can be prepared synthetically.

As the source is plant, it is Halal.

Halal.

Agar Agar

Naturally occurs as seaweed, used in place of gelatine

As the source is plant, it is Halal.

Halal.

Beta-apo-8- Carotenal (C30) (Apocarotenal) (E160e)

An orange/yellow colour derived from plants but may utilise gelatine or lard to dissolve in water.

If lard or gelatine made from animal (other than fish) is used then it will not be suitable for Halal use.

Products containing this additive are Halal regardless of the source of the additives

Carmine / Cochineal (E120)

A colour obtained from a dried female insect, cochineal.

It is not suitable for Halal use.

Products containing this additive are Halal.

Casein

A protein of milk used in the manufacture of cheeses. It is precipitated by acid or by animal or vegetable enzymes.

If animal enzyme is used then it will not be suitable for Halal use.

Halal

Chocolate Liquor

Syrup made from chocolate and used for chocolate flavoured products. It is not liquor or alcohol but because it is a liquid it is called liquor.

It is suitable for Halal use.

It is suitable for Halal use.

Dextrose (corn syrup)

Made from starch, used as a sweetener or colouring agent.

As the source is plant, it is suitable for Halal use.

As the source is plant, it is suitable for Halal use.

E153 – Carbon Black

A colour obtained by charring bones, meat, blood, wood, vegetable etc.

If charred from wood or vegetables then it will be suitable for Halal use.

Halal, regardless of its source.

E322 Lecithin

An emulsifier originally obtained from egg yolk but commercially prepared from Soya bean oil

It is suitable for Halal use.

It is suitable for Halal use.

 

ISO 22000:2005

A management system designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption.

 

Background of the ISO 22000 standard

Faced with the risk of poisoning collectively, the latest food crisis, increasing the life of food products and the extension of the food chain, large retailers and some nations have developed their own repositories to ensure food safety for consumers.

The BRC (British Retail Consortium) is a repository developed by British supermarkets. The first version of this reference is dated 1998 and was succeeded 3 other versions of the last of which was published in January 2005.

In 2002, the french and German dealers have created their own repositories: IFS (International Food Standard). This repository has been updated continuously;its4th version is published in January 2004.

The BRC and the IFS are private repositories of requirements that specify the means and results to ensure food safety in MDD (Marks distributors). Manufacturers wishing to sell their food products to major retailers British, German or french must meet the requirements of a reference or both simultaneously depending on the destination of their goods.

Apart from private repositories, several countries like Canada, Denmark, the Netherlands, Ireland, Australia, Morocco and many other countries have developed their own national benchmarks on the safety management of food . The need for harmonization of regulations and standards relating to food safety, grouped into a recognized international has been strongly voiced by the actors of the food for many years. The purpose behind this requirement is to minimize the cost of managing and maintaining multiple repositories simultaneously.

In 2001, the Danish Association for Standardization (DS) has submitted to the secretariat of ISO / TS 34 "Food" a proposal to develop an international standard management system of food safety. The application was accepted and work on the ISO 22000 standard was officially started in 2002 within ISO / TS 34. This work led to the publication of the new ISO 22000 in September 2005.

ISO 22000:2005 specifies the requirements for a Food Safety Management System (FSMS) that combines the following generally recognized key elements:

- Interactive communication

- System management

- Pre - requisite programs

- CODEX HACCP principles

It is a specification for any organization in the food chain

ISO 22000:2005 Process Model

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Systemic approach

The management system has its origin in ISO 9001: 2000. It allows the planning and updating of the system. This principle is based on the integration of all management systems of food safety in a structured management system which takes account of other general management of the organization.

ISO 22000 is based on the principle of Deming wheel and continuous improvement loop type PDCA (Plan, Do, Check, Act) which is now recognized as a principle of managerial conduct after simple and universal have demonstrated its effectiveness in Japan. The figure below illustrates this principle.

 

 

 

 

 

 

 

 

The structure of ISO 22000 takes into account the provisions contained in ISO 9001: 2000 to allow full compatibility and complementarity with the different standards of management used by companies. It is based on four main blocks closely related:

  • The responsibility of management;
  • The management of resources;
  • The planning and realization of safe products;
  • Validation, verification and improvement of the management system of food safety.

 

The management system has its origin in ISO 9001: 2000. It allows the planning and updating of the system. This principle is based on the integration of all management systems of food safety in a structured management system which takes account of other general management of the organization.

ISO 22000 is based on the principle of Deming wheel and continuous improvement loop type PDCA (Plan, Do, Check, Act) which is now recognized as a principle of managerial conduct after simple and universal have demonstrated its effectiveness in Japan. The figure below illustrates this principle.

 

The structure of ISO 22000 takes into account the provisions contained in ISO 9001: 2000 to allow full compatibility and complementarity with the different standards of management used by companies. It is based on four main blocks closely related:

  • The responsibility of management;
  • The management of resources;
  • The planning and realization of safe products;
  • Validation, verification and improvement of the management system of food safety.

 

ISO 22000:2005(Food Safety Management System)

What are HACCP / ISO 22000 (FSMS)?

Hazard Analysis and Critical Control Point (HACCP) / ISO 22000 Food Safety Management System is a process control system designed to identify and prevent microbial and other hazards in food production and entire food chain. HACCP includes steps designed to prevent problems before they occur and to correct deviations through a systematic way as soon as they are detected.

Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food.

HACCP / ISO 22000 enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety.

The ISO 22000:2005 standard outlines Food Safety Management System Requirements for any organization in the food chain, and is one of a family of standards focused at the development, implementation and improvement of a food safety management system.

Who should use ISO 22000:2005?

Since ISO 22000 is a generic food safety management standard it can be used by any organization directly or indirectly involved in the food chain including- Farms, Fisheries and Dairies, Processors of Meats, Fish and Feed, including Manufacturers of soups, snacks, bread, cereal, beverages, canned and frozen food, etc as well as food service providers such as restaurants, fast food chains, hospitals and hotels.

 Supporting services should not be forgotten and providers of food transportation storage and distribution, catering services as well as product suppliers for equipment, 3

additives, raw materials, cleaning and sanitizing products, packaging. In short if your products touch the food industry or the food we eat, part or all of the ISO 22000 requirements will apply.

The Benefits of implementing HACCP / ISO 22000 (FSMS)

A preventative approach to food safety

Can help identify process improvements & reduced customer complaints

Reduces the need for, and the cost of end product testing

Is complementary to quality management systems such as ISO 9000

Provides evidence of due diligence & reduces the likelihood of product recall & adverse publicity

Enhances customer satisfaction / reduces dissatisfaction

Facilitates better understanding of food packaging safety issues throughout the organization

Improves staff performance through the promotion of team spirit & improves staff morale and motivation through a cleaner working environment

A clear, auditable, global standard providing a framework to bring together all parts of your Food Safety Management System (FSMS)

Demonstrates commitment to customer satisfaction

Tests compliance with statutory and regulatory requirements and your own systems through internal audits and management reviews

Improves internal and external communications

Improves your organizations image

Links pre-requisite programs (PRP’s & OPRP’s), HACCP with the Plan-Do-Study-Act philosophies of ISO9001 to increase the effectiveness of your food management system

Requires regular testing of data integrity / lot recall programs and process audits

Aligns with other management systems (ISO 9001, ISO 14001)

 

 

CODEX - Application of a HACCP based hazard control system

5 Steps

• Assemble the HACCP team

• Describe the product

• Identify the intended use

• Construct a flow diagram

• Confirm accuracy of the flow diagram

4 Seven Principles

• Carry out Hazard Analysis and list the control measures

• Determine the Critical Control Points (CCPs)

• Establish Critical Limits for each CCP

• Establish monitoring system for each CCP

• Establish corrective actions

• Establish verification procedures

• Establish documentation and record keeping

 

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