NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT (AS AMENDED)

CURRENT GOOD MANUFACTURING PRACTICE FOR FOOD AND FOOD PRODUCTS REGULATIONS 2009

Commencement:In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control by sections 5 and 29 of the National Agency for Food and Drug Administration and Control Act (as amended) and all the powers enabling it in that behalf, the Governing Council of the National Agency for Food and Drug Administration and Control with the approval of the Honourable Minister of Health hereby makes the following regulations:-

1. These regulations prescribe the minimum current good manufacturing practice requirements for manufacturing, processing, packaging or holding of a food or food product for human and animal use, to ensure that such food or food products meet the requirements of safety, quality, wholesomeness and suitability for consumption.

Scope

2. Except as provided in these regulations, failure to comply with any provision set forth in these regulations in respect of manufacturing, processing, packaging, or holding of a food or food product for human and animal use, shall render such food or food product unwholesome and/or adulterated and such food or food product, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.

Prohibition

3. The management shall take all reasonable measures and precautions to ensure that: a. There is an adequate organizational structure that clearly defines the responsibility, authority, interrelationships and qualification of all personnel. b. The quality control unit is a distinct organizational unit that functions and reports to management independently of all other functional units.

Organization and Personnel

4 a. Each person engaged in the manufacturing, processing, packaging, or holding of a food or food product shall have appropriate education, training, and experience, or any combination thereof, to enable that person perform the assigned functions. b. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations and standard operating procedures required in these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to ensure that employees remain familiar with current good manufacturing practice requirements applicable to them. c. There shall be an adequate number of qualified personnel to perform and supervise the manufacturing, processing, packaging, or holding of each food or food product. 5. Any person who, by medical examination, supervisory observation or voluntary personal report is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, foodcontact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.

Personnel Qualification

Disease Control

6. All persons working in direct contact with food, food-contact surfaces, and foodpackaging materials shall conform to the requirements of the Agencys Food Safety Regulations and other measures to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to: i. Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food contact surfaces, or food-packaging materials. ii. Complying with appropriate hygienic measures such as walking through a foot bath, using shoe covers, changing foot wears for more sensitive areas. Street shoes shall not be permitted in the processing areas. iii. Maintaining adequate personal cleanliness. iv. Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. v. Removing all jewelry and other objects that might fall into food, equipment, or containers.

Cleanliness

vi.

vii. viii. ix.

x.

Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves shall be of an impermeable material. Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints. Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. Confining the following activities to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

a. Personnel responsible for ensuring good hygienic and sanitation practices shall have a background of education, training and experience, or a combination thereof, to provide a level of competency necessary for production of wholesome and safe food. b. Food handlers and supervisors shall receive appropriate training in proper food handling techniques and food-protection principles and shall be informed on the dangers of poor personal hygiene and insanitary practices.

Education and Training

8. Responsibility for ensuring compliance by all personnel with all requirements of these regulations shall be clearly assigned to competent supervisory personnel.

Supervision

9 a.

The building used for the manufacturing, processing, packaging, labelling and storing of food or food product shall be adequately located, designed, constructed, and of suitable size to facilitate cleaning, maintenance and proper operations. The orderly flow of personnel, materials, and products through the building shall be designed to prevent contamination. The flow of persons and traffic to and from production areas shall be clearly indicated and controlled.

Buildings and Facilities

b.

10 .

The premises about a food establishment under the control of the operator shall be kept in a condition that will protect against contamination of food. The methods for adequate maintenance of premises include, but are not limited to: i. Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the factory buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

Premises

ii. iii. iv.

v.

Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed. Adequately draining areas that may contribute to the contamination of food by seepage, foot-borne filth, or providing a breeding place for pests. Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. Where the factory premises are bordered by other areas not under the operators control and not maintained in the manner prescribed in sections 10 (i) to (iv) of these regulations, care shall be exercised by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.

11. Buildings and structures shall be suitable in design, construction and size to facilitate maintenance and hygienic operations for food-manufacturing purposes. The factory and facilities shall: a. Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of hygienic operations and the production of safe food. b. Permit proper precautions to be taken to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with micro organisms, chemicals, filth, or other extraneous materials. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means. c. Permit proper precautions to be taken to protect food in outdoor bulk fermentation vessels by any effective means, including: i. Using protective coverings. ii. Controlling areas over and around the vessels to eliminate harborages for pests. iii. Adequate controls for pests and pest infestation. iv. Skimming the fermentation vessels, as necessary. d. Be constructed in such a manner that: i. Floors, walls, and ceilings may be adequately cleaned, kept clean and maintained in good repair; ii. Drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; iii. Aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or foodcontact surfaces with clothing or personal contact. e. Provide adequate lighting in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any

Construction and design

step of preparation or otherwise protect against food contamination in case of glass breakage. f. Provide adequate ventilation or control equipment to minimize odours and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces. g. Provide, where necessary, adequate screening or other protection against pests.

12. Cleaning and sanitation programmes shall be in place and shall include details such as cleaning schedule, responsibilities, methods of cleaning, equipment, cleaning aids to effectively control contamination of food. These shall be continuously monitored for their effectiveness. It shall be ensured that cleaning chemicals do not contaminate food.

Hygienic Operations

13. Buildings, fixtures, and other physical facilities of the factory shall be maintained in a sanitary condition and shall be kept in good repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.

General maintenance

14. a. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable micro organisms and shall be safe and adequate under the conditions of use. Only the following toxic materials may be used or stored in a factory where food is processed or exposed: i. Those required to maintain clean and sanitary conditions; ii. Those necessary for use in laboratory testing procedures; iii. Those necessary for factory and equipment maintenance and operation; and iv. Those necessary for use in the factorys operations. c. Toxic cleaning compounds, sanitizing agents, chemicals and pesticides shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other government agencies for the application, use, or holding of these products shall be followed.

Substances used in cleaning and sanitizing; storage of toxic materials

15 a. Suitable and effective pest control programme shall be in place to ensure there are no signs of pest infestation including flies, cockroaches, lizards, rats, and other vermins. The pest control programme shall include but not limited to identification of the pests to be controlled, the area/locations where control is to be applied, the method of control, the dosage in case of usage of chemical, the schedule and responsibilities.

Pest control

b.

c.

Pest control shall be performed by trained personnel, continuously monitored for effectiveness and measures shall be documented and records maintained. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food packaging materials. No pets shall be allowed in any area of a food factory. Guard or guide dogs may be allowed in some areas of a factory if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food packaging materials. Effective measures shall be taken to exclude pets from the processing areas and to protect against the contamination of food on the premises by pets.

16. a. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. b. Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wetcleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. c. In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary. d. Non-food-contact surfaces of equipment used in the operation of food factories shall be cleaned as frequently as necessary to protect against contamination of food. e. Single-service articles shall be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces. f. Sanitizing agents shall be adequate and safe under prescribed conditions of use. f.g. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.

Sanitation of food-contact surfaces

Storage and handling of cleaned Portable equipment and utensils

17. Cleaned and sanitized portable equipment with food contact surfaces and utensils shall be stored in a location and manner that protects food-contact surfaces from contamination.

Sanitary facilities and controls

18. Each factory shall be equipped with adequate sanitary facilities which shall include, but not limited to:

1a. The water supply shall be from an adequate source and be sufficient for the operations intended. b. Any water in contact with food or food-contact surfaces shall be safe and of adequate sanitary quality. It shall conform to the Nigerian Industrial Standards for drinking water. c. Running water shall be provided in all areas where required for the processing of food, cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities and such water shall be at a suitable temperature, and under pressure as needed. 2. Plumbing shall be of adequate size and design and adequately installed and maintained to: a. Carry sufficient quantities of water to required locations throughout the factory. b. Properly convey sewage and liquid disposable waste from the factory. c. Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. d. Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor. e. Ensure that there is no backflow from, or cross-connection between piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. Sewage disposal shall be made into an adequate sewage system or disposed of through other adequate means as prescribed by the competent authority. Each factory shall provide its employees with adequate, readily accessible toilet facilities which shall be maintained in good sanitary condition and in good state of repair. Toilet doors shall not lead directly into areas where food is processed, packaged or stored.

Water supply

Plumbing

3.

Sewage disposal Toilet facilities

4.

5.

Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement shall be accomplished by providing: a. Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the factory where good sanitary practices require employees to wash and/or sanitize their hands. b. Effective hand-cleaning and sanitizing preparations. c. Single use towels or suitable drying devices.

Hand-washing facilities

d. Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. e. Readily understandable signs directing employees handling unprotected food, unprotected food-packaging materials, or food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces.

6a. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odour, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces. b. Refuse receptacles shall be constructed and maintained in a manner that protects against contamination of food.

Rubbish and offal disposal

Equipment
a. All factory equipment and utensils shall be designed with such material and workmanship as to be easily and adequately cleanable, and properly maintained. The design, construction, and use of equipment and utensils shall prevent the contamination of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminant. b. Seams on food-contact surfaces shall be smoothly bonded and maintained so as to minimize accumulation of food particles, dirt, and organic matter and therefore minimize the opportunity for growth of microorganisms. c. All equipment and utensil surfaces in contact with food shall be made of corrosion resistant, non-toxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds and sanitizing agent. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. d. Equipment and utensils used to manufacture, process, pack, or hold food or food products shall be designed, constructed, installed and maintained to: i. Protect food from contamination ii. Facilitate the cleaning, sanitizing and maintenance of the equipment and of all adjacent spaces. e. Equipment, instruments, apparatus, gauges, and recording devices shall be calibrated at suitable intervals in accordance with an established written program containing specific instructions, schedules, limits for accuracy and precision, and provisions for remedial action in the event that accuracy and/or precision limits are not met. Equipment, instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used. f. All food contact surfaces including utensils and food contact surfaces of equipment shall be cleaned as frequently as necessary to protect against contamination of food. 19

Equipment and Utensils

g. Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition. h. Cleaned and sanitized portable equipment with food contact surfaces and utensils shall be stored in a location and manner that protects food contact surfaces from contamination. i. Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition. j. Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment, and shall be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation. k. Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be adequate in number, accurate and adequately maintained for their designated uses. l. Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall comply with standard quality requirements and be treated in such a way that food is not contaminated with unlawful indirect food additives.

20 a. There shall be standard operating procedures for all operations and controls for manufacturing, processing, packaging, holding, distributing, recalling, cleaning, and maintenance control designed to ensure that the food or food products are safe, wholesome and are of the quality they purport to possess. These standard operating procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality assurance unit. b. Standard operating procedures for production and process control procedures shall be followed and documented at the time of performance.

Standard Operating Procedure

Production and Process Controls

21. a All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles.

Processes and controls

b. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food packaging materials are safe and suitable. c. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute to contamination from any source. d. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. e. All food that has become contaminated to the extent that it is adulterated shall be rejected, or where permissible, treated or reprocessed to eliminate the contamination as may be prescribed by the Agency.

22 a.

b.

c. d.

e.

f.

g.

Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. No raw materials or ingredients shall be accepted by a food establishment if they are known to be, or might reasonably be expected to be, so contaminated with parasites, pathogenic micro-organisms, or toxic, decomposed or foreign substances, that after normal sorting and/or preparatory or processing procedures hygienically applied by food establishments, would still be adulterated or unfit for human consumption. Hazardous and/or inedible substances, including animal feedstuffs, shall be adequately labelled and stored in separate and secure containers. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Potable water shall be used for washing, rinsing, or conveying. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials shall be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food. Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of these regulations. Raw materials and other ingredients susceptible to contamination with aflatoxins or other natural toxins shall comply with regulations and guidelines of the Agency, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or other extraneous matter shall comply with applicable regulations of the Agency, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any

Raw materials control

10

effective means, including purchasing the materials under a suppliers guarantee or certification, or examination of these materials for contamination. h. Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of these regulations. Material scheduled for rework shall be identified as such. i. Frozen raw materials and other ingredients shall be kept frozen. Where thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming contaminated within the meaning of these regulations. j. Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

23 a. Equipment, utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Equipment shall be taken apart for thorough cleaning as necessary. b. All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. c. Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated. d. Heat treating acid or acidified foods in order to destroy mesophilic microorganisms when such foods are to be held in hermetically sealed containers at ambient temperatures. e. Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or water activity that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated. f. Work-in-process shall be handled in a manner that protects against contamination. g. Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. Raw materials, other ingredients, or refuse shall not be handled simultaneously in a receiving, loading, or shipping area. Food transported by conveyor shall be protected against contamination. h. Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. i. Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. j. Food, raw materials, and other ingredients that are adulterated shall be disposed in a manner that protects against the contamination of other food. k. Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding,

Manufacturing operations

11

l.

m.

n. o.

p.

q. r.

drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Blanching, when required in the preparation of food, shall be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers shall be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality. Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Filling, assembling, packaging, and other operations shall be performed in such a manner that the food is protected against contamination. Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of water activity for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at an appropriate pH. When ice is used in contact with food, it shall be made from potable water. Food-manufacturing areas and equipment used for manufacturing human food shall not be used to manufacture non-human food-grade animal feed or inedible products.

24.

Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as prevent deterioration of the food and the container.

Warehousing and Distribution

25 a. Defect action levels shall apply to natural or unavoidable defects in food for human use that present no health hazard b. All foods shall comply with maximum defect action levels established from time to time by the Agency. c. Foods produced based on new and advanced technologies, formulations, or based on the availability of new information that comply with maximum defect action levels shall not be hazardous to health. d. The manufacturer, distributor and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible. e. The mixing of a food containing defects above the current defect action level with another lot of food shall not be permitted and shall render the final food adulterated

Defect Action levels

12

f.

Compliance with defect action levels shall not excuse violation of the requirement of these regulations.

26.a

A manufacturer of food or food products shall have a quality assurance system in place that identifies, implements, monitors and verifies critical factors in the manufacturing, processing, packaging, holding and distribution of food and that effectively prevents contamination or adulteration of food and ensures food safety. b. A quality assurance system shall meet all the requirements of the Agency including the following: i. Provide mechanisms to identify specific ingredients or food additives and the amounts used in a food; ii. Provide mechanisms to control the use of food additives and nutrients as prescribed by the Agency; iii. Ensure that information on a food label is complete and accurately represents the food; iv. Ensure that controls are put in place to prevent mislabelling of food. v. Ensure that shelf life studies are carried out to establish the best before, use by, and other relevant date markings for food or food products.

Quality Assurance Systems

27. A manufacturer of food or food products shall control food hazards through the use of systems such as Hazard Analysis and Critical Control Points. The manufacturer shall: a. Identify any steps in their operations which are critical to the safety of food or food products b. Implement effective control procedures at those steps; c. Monitor control procedures to ensure their continuing effectiveness and d. Review control procedures periodically, and whenever the operations change.

Control of hazards

28. A manufacturer of food or food products shall have procedures in place to deal with deviations or defects that could affect food safety in their quality assurance program

Deviation or defect in quality assurance

29.

A manufacturer of food or food products shall establish: a. A written procedure that ensures the timely and complete recall of any batch/lot of food or food products b. A distribution record to enable the manufacturer to recall any batch/lot of a food or food product.

Recall of food or food product

13

c. That food or food product returned to a manufacturer as part of a recall, shall

be held for re-work or disposal under the direction and supervision of the Agency.

30. a. Records shall provide appropriate history of each batch of food or food product, including its distribution, and all other relevant circumstances pertinent to the quality of the final product. b. The records shall be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of food or food product are traceable. Any production, control, or distribution record that is required to be maintained in compliance with this section and is specifically associated with a batch of a food or food product shall be retained for at least 1 year after the expiration date of the batch. c. Records shall be maintained for all materials for at least 1 year after the expiration date of the food or food product. d. All records required under this section, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this section. e. Records required under this section may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records and the accuracy of the records shall be checked. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. f. Written records required by this section shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each food or food product to determine the need for changes in food or food product specifications or manufacturing or control procedures. Standard operating procedures shall be established and followed for such evaluations and shall include provisions for: i. Review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch. ii. Review of re-work, complaints, recalls or returned food or food products, and investigations conducted under section 34 for each food or food product. g. Procedures shall be established to ensure that the responsible persons, where they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under section 34 of these regulations, any recalls, reports of inspectional observations issued by the

Documentation and records

14

Agency, or any regulatory actions relating to good manufacturing practices brought by the Agency. h. Written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and number of each batch processed. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. i. Persons performing and double-checking the cleaning and maintenance shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.

31. These records shall include the following: a. Identity and quantity of each shipment of each lot of materials. b. Name and location of the prime manufacturer, where different from the supplier. c. Results of any test or examination performed (including those performed as required and the conclusions derived therefrom). d. Individual inventory record of each material and record of reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of food or food product associated with the use of each component, food or food product container, and closure. e. Documentation of the examination and review of labels and labeling for conformity with established specifications shall be as prescribed by the Agency. f. The disposition of rejected materials. 32. a. To ensure uniformity from batch to batch, master production and control records for each food or food product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a standard operating procedure which shall be followed. b. Master production and control records shall include: i. The name, ingredient list and a description of the food product; ii. The unit of weight or measure of the food or food product, and a statement of the net weight or measure; iii. A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic; iv. An accurate statement of the weight or measure of each component, using the same weight system. A statement concerning any calculated excess of component; v. A statement of theoretical weight or measure at appropriate phases of processing;

Material records

Master production and control records

15

vi. A statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation is required as prescribed in section 34 vii. A description of the food or food product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling; viii. Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.

33.

Batch production and control records shall be prepared for each batch of food or food product produced and shall include complete information relating to the production and control of each batch. These records shall include: i. An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed; ii. Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including: 1. Date and time; 2. Identity of individual major equipment and lines used; 3. Checks that the equipment and work station are clear of previous products, documents or materials not required for the planned process, and that equipment is clean and suitable for use; 4. Specific identification of each batch of component or in-process material used; 5. Weights and measures of components used in the course of processing; 6. In-process and laboratory control results; 7. Inspection of the packaging and labeling area before and after use; 8. A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing; 9. Complete labeling control records, including specimens or copies of all labeling used; 10. Description of food or food product containers and closures; 11. Any sampling performed; 12. Identification of the persons performing and directly supervising or checking each significant step in the operation; 13. Any investigation made as prescribed in section 34; and 14. Results of examinations made.

Batch production and control records

34 a. All food or food product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established and approved standard operating procedures before a batch is released or distributed.

Production record review

16

b.

Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same food or food product and other food or food products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.

35 a. Laboratory records shall include complete data derived from all tests necessary to ensure compliance with established specifications and standards, including examinations and assays, as follows: i. A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity, batch number or other distinctive code, date sample was taken, and date sample was received for testing. A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. The suitability of all testing methods used shall be verified under actual conditions of use. A statement of the weight or measure of sample used for each test, where appropriate. A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, food or food product container, closure, in-process material, or food or food product and batch tested. A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalency factors. A statement of the results of tests and how the results compare with established standards of identity and quality of food or food product container, closure, in-process material, or food or food product tested. The initials or signature of the person who performs each test and the date(s) the tests were performed. The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.

Laboratory records

ii.

iii. iv.

v.

vi.

vii. viii.

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b. Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are accurate and reliable for the material being tested as the established method. c. Complete records shall be maintained of all out-of-specification investigations carried out as prescribed in section 30. d. Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions. e. Complete records shall be maintained of the periodic calibration of laboratory instruments, apparatus, gauges, and recording devices. f. Complete records shall be maintained of all shelf life studies performed.

36. Distribution records shall contain the following: a. b. c. d. e. f. Name and pack size of the product Description of the food or food product, Name and address of the consignee, Date and quantity shipped, Batch or control number of the food or food product. Date of manufacture and best before date.

Distribution records

37. a. Standard operating procedures describing the handling of all written and oral complaints regarding a food or food product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a food or food product to meet any of its specifications and, for such food or food products, a determination as to the need for an investigation as prescribed in section 34. Such procedures shall include provisions for review to determine whether the complaint represents a serious health hazard. b. Written record of each complaint shall be maintained in a file designated for food or food product complaints. The file regarding such food or food product complaints shall be maintained at the establishment where the food or food product involved was manufactured, processed, or packed, or such file may be maintained at another facility where the written records in such files are readily available for inspection at that other facility. c. Written records involving a food or food product shall be maintained until at least 1 year after the expiration date of the food or food product, or 1 year after the date that the complaint was received, whichever is longer.

Complaint files

18

d. The written record shall include the following information where known: i. ii. iii. iv. v. vi. Name and pack size of the product, Batch number, NAFDAC registration number, Name and address of complainant, Nature of complaint, and reply to complainant. Date of manufacture and best before date.

e. Where an investigation is conducted, the written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred as prescribed in section 30. f. Where an investigation as prescribed in section 34 is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.

38a. All product recall activities whether voluntarily or directed by the Agency shall be carried out expeditiously and the records kept. b. There shall be a standard operating procedure describing a product recall and shall define the circumstances under which a recall of a food or food product shall be considered as prescribed by the Agency. c. The recall procedure shall designate: i. ii. iii. iv. Who shall be involved in evaluating the information, How a recall shall be initiated, Who shall be informed about the recall, and How the recalled material shall be treated.

Recall records

d. In the event of a voluntary recall or serious and/ or potentially life-threatening situation, local, national, and/or international authorities shall be informed and their advice sought. e. Appropriate investigation for reason for the recall shall be conducted as prescribed in section 34. f. Where an investigation under section 34 is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.

39. a. A person who contravenes a provision of these regulations is guilty of an offence and liable on conviction:-

Penalty

19

i.

ii.

in the case of an individual, to imprisonment for a term not exceeding two years or to a fine not exceeding N50,000 or to both imprisonment and fine. In the case of body corporate, to a fine not exceeding N100,000.

b. Where an offence under these Regulations is committed by a body corporate or firm or other association of individuals:i. every director, manager, secretary or other similar officer of the body corporate; or ii. iii. iv. v. every partner or officer of the firm; or every trustee of the body concerned; or every person concerned in the management of the affairs of the association; or every person who was purporting to act in a capacity referred to in paragraphs (i) to (iv), is severally guilty of that offence and liable to be proceeded against and punished for that offence in the same manner as if he had himself committed the offence unless he proves that the act or omission constituting the offence took place without his knowledge, consent or connivance.

40. In these regulations, unless the context otherwise requires, the following terms shall have the meanings specified:

Interpretations

Foods that have an equilibrium pH of 4.6 or below. That which is needed to accomplish the intended purpose in keeping with good public health practice. Adulteration Food that has been prepared, packed, or held under condition that is unfit for human consumption whereby it may have become contaminated with filth, chemical or microbial substances and it may have been rendered injurious to health. Agency National Agency for Food and Drug Control and Administration Batch/Lot The food produced during a period of time indicated by a specific code. Batter A semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. Blanching, except for tree A prepackaging heat treatment of foodstuffs for a sufficient time nuts and peanuts and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. Competent authority Ministry, Department or Agency responsible for environmental (environmental issues) issues

Acid foods or acidified foods Adequate

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Contamination

Critical control point

Defect Action Levels Factory

Food

Food-contact surfaces

Good Manufacturing Practice

Microorganisms

Offal

Pest Potable water

Quality assurance

Quality control operation

The undesired introduction of impurities of physical, chemical or microbiological nature of foreign matter into or onto a starting/raw material, intermediate or finished product during production, sampling, packaging or repackaging, storage or transport A point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food. Level of natural or unavoidable defects in food for human use that present no health hazard The building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human or animal food. Any article manufactured, sold or advertised for use as food or drink and includes drinking water, chewing gum, and other ingredients as may be mixed with food for any purpose whatsoever, including supplements processed for addition to animal and poultry feeds. Those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces includes utensils and foodcontact surfaces of equipment. The application of scientifically sound methods, practices or principles and appropriate documentation during product development and production to ensure that such products are consistently manufactured to the specified safety and quality standards Yeasts, moulds, bacteria, and viruses and include, but are not limited to, species having public health significance. The term undesirable microorganisms includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of these regulations. Any edible part including blood and its products of any animal or bird that is not included in the definition of meat or mechanically recovered meat Any objectionable animal or insect including, but not limited to, birds, rodents, flies, and larvae. Water which is: i. Fit for consumption by humans ii. Meets Nigerian Industrial Standards for drinking water A program for the systematic monitoring and evaluation of the various aspects of a project, service or facility to ensure that the standards of quality re met A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the

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Regulatory action

Re-work

Safe moisture level

Sanitize

Shall Should Unwholesome Water activity (aw)

Work in process (WIP)

meaning of these regulations Includes but are not limited to product hold, recall, forfeiture, or destruction, sealing of manufacturing line or facility, withdrawal of product license/registration certificate, prosecution Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. A level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity To adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. Used to state mandatory requirements. Used to state recommended or advisory procedures or identify recommended equipment. Food unfit for human consumption A measure of the free moisture in a food or food component and it is a quotient of the water vapour pressure of the substance divided by the vapour pressure of pure water at the same temperature. A water activity will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms. Partially processed products that are no longer part of the raw materials inventory and not yet part of the finished product inventory, waiting for further processing or in the buffer storage.

41. These Regulations may be cited as Current Good Manufacturing Practice for Food and food products Regulations 2009 MADE AT ABUJA THIS.DAY OF..2009 Dr. Philip Emafo PhD. OFR
Chairman Governing Council National Agency for Food and Drug Administration and Control (NAFDAC).

Citation

Dr. Paul Orhii JD, MD, PhD.

Director-General, National Agency for Food and Drug Administration and Control (NAFDAC)

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