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Good Manufacturing Practice in Brazilian wheat mills - BVS SES-SP
Rev Inst Adolfo Lutz
DOI: 10.18241/0073-98552014731590
Artigo Original/Original Article
Good Manufacturing Practice in Brazilian wheat mills with particular
reference to the flour fortification
Boas Práticas de Fabricação em moinhos de trigo com particular
referência à fortificação de farinhas
RIALA6/1590
William Cesar LATORRE1,2, Célia COLLI1,3*
*Correspondence adress: 3Department of Foods and Experimental Nutrition, Faculty of Pharmaceutical Sciences, University
of São Paulo, Av. Prof. Lineu Prestes 580, 05508-000, São Paulo, SP, Brazil. E-mail: [email protected]
1
Program of Applied Human Nutrition (PRONUT) – FSP/FCF/FEA, University of São Paulo, São Paulo, SP, Brazil
2
Granotec do Brasil, Curitiba, PR, Brazil
Recebido: 27.08.2013 - Aceito para publicação: 25.02.2014
ABSTRACT
Iron deficiency anemia (IDA) is a widespread nutritional disorder that affects a significant proportion of
the Brazilian population. The obligatory fortification of wheat flour with iron and folic acid represents a
strategy of the Brazilian Ministry of Health for combating IDA. However, several studies have reported
the occurrence of iron in excessive concentrations and insufficient contents of folic acid in commercial
flour samples. In the light of these information, a participatory observational study on the wheat flour
production processes was undertaken in 11 major flour mills located in the São Paulo state, Brazil. This
study aimed at writing a detailed good manufacturing practice (GMP) guidelines for the industrial
sectors, including directives for standardized operational procedures (SOPs) on the flour fortification. The
outcomes of this study are a GMP checklist and the recommended SOPs, which help to standardize the
production processes in flour fortification, which currently is incongruous one, and also to facilitate the
work of the government health inspectors.
Keyword. good manufacturing practice, standardized operational procedures, wheat flour fortification,
iron deficiency.
RESUMO
Anemia por deficiência de ferro (ADF) é um distúrbio nutricional generalizado que afeta uma parcela
significativa da população brasileira. A fortificação obrigatória das farinhas de trigo com ferro e ácido
fólico representa uma estratégia do Ministério da Saúde para o combate à ADF. No entanto, há relatos que
indicam a ocorrência de concentrações excessivas de ferro e quantidades insuficientes de ácido fólico em
amostras comerciais de farinha de trigo. À luz destas informações, foi realizado este estudo observacional
participativo nos processos de produção de farinha de trigo em 11 moinhos, localizados no estado de São
Paulo, Brasil, para criar para este setor industrial, uma lista de verificação das Boas Práticas de Fabricação
(BPF), incluindo-se diretrizes para os procedimentos operacionais padronizados (POPs) na fortificação de
farinha. A implementação dessas ferramentas ajudam a padronizar os processos de produção, atualmente
incongruentes na fortificação das farinhas, bem como facilitam o trabalho dos inspectores de saúde do
governo.
Palavras-chave. boas práticas de fabricação, procedimentos operacionais padronizados, fortificação da
farinha de trigo, deficiência de ferro.
Rev Inst Adolfo Lutz. 2014; 73(1):67-76
67
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
INTRODUCTION
Iron deficiency anemia (IDA) is one of the most
important nutritional problems in Brazil since it affects
a significant proportion of the population irrespective of
economic class. Among the various measures introduced
by the Brazilian Ministry of Health with the purpose of
combating IDA has been the fortification of wheat and
corn flour with iron and folic acid. In 2002, the National
Sanitary Surveillance Agency (Agência Nacional de
Vigilância Sanitaria; ANVISA), published a resolution
determining the compulsory fortification of flour with
iron (4.2 mg/100 g) and folic acid (150 µg/100 g)1.
In 2005, Latorre surveyed the opinions and
perceptions of managers in the wheat milling industry
regarding the obligatory fortification of flour. The
collective discourse revealed that the policy had received
general approbation and was being implemented by
the flour mills. However, according to this author, the
legislation was considered authoritarian and had been
applied without consultation with the industrial sector.
Of particular concern were: (i) the tendency to overdose
micronutrients in order to avoid technological issues,
and (ii) the lack of availability of rapid analyses from
laboratories2. Additionally, a report from the Sanitary
Surveillance Center of the State of São Paulo, Brazil,
has revealed that commercial samples of flour are often
overdosed with iron and underdosed with folic acid3.
In the light of this information, a participatory
observational study of wheat flour production processes
in 11 mills across the state of São Paulo was undertaken
employing ethnographic method to observe the flour
milling daily practices with the aim of verifying if this
method is appropriate to elaborate good manufacturing
practice (GMP) guidelines for the industrial sector including
directives for standardized operational procedures (SOPs)
in flour fortification and to investigate variations among
protocols and controls used by different mills.
The Centers for Disease Control and Prevention4
and the World Health Organization (WHO)5, along
with other acknowledged experts6, consider the flour
fortification strategy to be a centralized and managed
public health program that includes the monitoring
of industrial operations in order to guarantee the
quality of the final product. Industrial practices in all
flour-producing mills should comply fully with GMP
guidelines, and such operations must be monitored if the
health program is to be successful.
68
Nestel et al6 proposed a GMP checklist for
fortified flour based on the Codex Alimentarius7 and the
Food and Drug Administration (FDA) of the USA Health
Department norms8. These authors emphasized that the
FDA carries out routine inspections by specialist staff for
each type of product. It is suggested that the Brazilian
government should establish a similar procedure in order
to monitor compliance with GMP by the flour milling
industry, with particular reference to flour fortification.
In 1963, the World Health Organization and
the Food and Health Organization (WHO/FAO) of the
United Nations established the Codex Alimentarius
Commission with the aim of coordinating international
food standards, guidelines and codes of practice in order
to protect the health of consumers and to ensure fair
practices in international food trade7. Such codes are
adopted by the World Trade Organization as references
for all international trade in food products. Within
these norms, the Hazard Analysis and Critical Control
Point (HACCP) directives have been references for
international food safety requirements since 1991.
In 1969, the Codex Alimentarius Commission
published a manual entitled “International Code of
Recommended Practices – General Principles of Food
Hygiene” with the objective of providing guidance for
the elaboration of codes needed in specific sectors of
the food chain, processes or commodities in order to
amplify the hygiene requirements that are fundamental
to those areas9. This manual served as a benchmark for
the creation of GMP norms and gave rise to a further
publication entitled “Current Good Manufacturing
Practice in Manufacturing, Packaging or Holding Human
Food”10. Both documents had international impact and
influenced the development of generic and specific GMP
norms.
In 1993, the Brazilian Ministry of Health
published decree number 1428/MS11 containing
directives for the establishment of GMP in the food
sector. This decree conferred practical and wide-ranging
powers to food inspectors, and these were consolidated
by further regulations including: (i) Decree SVS/MS no.
326, which approves the technical regulation of GMP to
be implemented by food-producing companies12, and (ii)
Resolution RDC nº 275, which approves a GMP checklist
for food-producing companies13.
In addition to these fundamental regulations,
particular categories of foods were regulated by specific
GMPs and are subject to: (i) Resolution RDC nº 28,
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
which describes basic GMP procedures and routine
health inspections of companies that produce salt
for human consumption14, (ii) Law nº 6150, which
regulates the obligatory supplementation of salt with
iodine with the purpose of eradicating endemic goiter15,
(iii) Resolution RDC nº 23/2013, which specifies the
minimum and maximum levels of iodine in salt destined
for human consumption16, (iv) Decree no. 2.362/GM,
which restructures the National Program for Prevention
and Control of Iodine Deficiency Illnesses17, and (v)
Decree no. 520/GM, which creates the Inter-institutional
Commission for Prevention and Control of Iodine
Deficiency Illnesses18.
For the purpose of ensuring the quality of
fortified flour according to the norms of the Brazilian
authorities, it would be reasonable to adopt HACCP as
a work tool and to employ SOP in the control of quality
and dosage of micronutrients. In this case, it is essential
to elaborate a GMP checklist including the SOP for the
flour fortification with iron so that mills can construct
their own detailed HACCP plans. Since the methods of
production and control of fortified flour vary among the
mills, it is clearly of the utmost importance to standardize
these procedures in order to ensure quality and safety,
as well as to facilitate the routine mill inspections by
ANVISA. On this basis, the aims of the present study
were: (i) to write a detailed GMP checklist to be used by
the flour industry during the production of flour fortified
with iron and folic acid, and (ii) to suggest SOP for all of
the steps in the production process.
MATERIAL AND METHODS
Details of the project were submitted to and
approved by the Ethical Research Committee of the
Faculdade de Ciências Farmacêuticas, Universidade de
São Paulo (CEP nº 03/12022009). All procedures were
performed in accordance with the Declaration of Helsinki
and written permissions for carrying out interviews,
discussions, observations and training of staff were
obtained from the managers of the participating wheat
milling industries and from the Centro de Vigilância
Sanitária de São Paulo (CVS; Secretaria de Estado da
Saúde, São Paulo, SP, Brazil). The anonymity of all mills
involved and of individual participants was maintained
rigorously throughout the study.
The participatory observational study described
herein was conducted during 2007 and 2008, and involved
11 major wheat flour mills located across the state of São
Paulo. In 2008, these mills were responsible for one third
of all of the flour produced in Brazil.
The ethnographic study was executed in three
stages. Firstly, a literature survey of scientific articles
and government publications was carried out in order
to draft a preliminary GMP checklist for the production
of fortified flour. Prior to the inspection stage, 20 CVS
health inspectors responsible for policing the selected
mills were invited to participate in the planning of the
project and to oversee the final GMP checklist. With the
support and approval of CVS, the research coordinator
organized and offered to the CVS inspectors’ theoretical
and practical training in the technology of wheat flour
production and aspects of health legislation relating
to GMP. At the inspection stage, the health inspectors
were charged with visiting the 11 wheat mills three
times according to a schedule arranged by the project
coordinator. During the first inspection, which occurred
prior to training, the health inspectors used the GMP
checklist published in the annex to Resolution RDC
nº 275 issued by ANVISA13. At the second visit, the
health inspectors tested and modified (where necessary)
the preliminary GMP checklist. Further checkpoints
relating to the production and fortification of flour were
then added to the preliminary GMP checklist, and this
new draft was employed during the third visit of the
inspectors. All stages of the study were closely supervised
by the research coordinator.
The model GMP checklist13 employed by the
health inspectors during the first visits to the mills
contained general items relating to food production,
such as industrial buildings and installations, aspects of
hygiene associated with equipment, furniture and utensils,
health status of the workers, hygienic conditions in the
production line and transport of food materials, and legal
documentation of the industrial procedures. A meeting,
chaired by the research coordinator, was held during the
first inspection of each mill at which the health inspectors
and the managers and staff in charge of flour production/
quality were present. The research coordinator attempted
to reassure the mill personnel about the presence of the
health inspectors by emphasizing the importance of
IDA in Brazil and the value of the fortification strategy
implemented by the government. The coordinator
presented the hypothesis and objectives of the research
project, and extensive discussions of the subject area were
permitted before the actual inspection of the production
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Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
line commenced. In this manner, considerable effort
was devoted into making sure that an agreeable climate
existed among the participating mill personnel in order
to avoid distorted observations and results. At the request
of the coordinator, the mill staff demonstrated the flour
production line and explained each of the steps of the
fortification process comprising the selection and control
of the micronutrients, the technology of dosing and the
quality control of the final product (Figure 1).
The collected observations by the health
inspectors gathered during the first and second visits
to the mills were incorporated into the preliminary
GMP checklist giving rise to a final checklist, which
was presented in a tabulated form similar to that used
by ANVISA to inspect other food areas. At the end of
the project, the health inspectors produced a report on
the final GMP checklist based on their experience in the
field.
RESULTS AND DISCUSSION
Figure 1. Simplified flow chart of the production of fortified wheat flour
All of the GMP checkpoints of flour production
in wheat mills were observed, from the reception of the
raw material to the packaging of the final product. In
this article, only GMP topics relevant to the production
of fortified flour are presented and discussed. Table
1, represents the final version of the GMP checklist
and the recommended SOPs only for the fortification
of flour with iron and folic acid operation, constructed
during the present study. Most of the CVS health
inspectors considered that the final GMP checklist was
appropriate since it contained a wide range of control
items that allowed its application in mills with different
characteristics.
Ethnography is defined as “the descriptive
Table 1. GMP checklist and SOP for the fortification of wheat flour with iron and folic acid
Identity of Mill
Function:
CNPJ:
Phone:
Fax:
E-mail:
Address:
Town:
State:
Post code:
Brands of flour produced:
Destination:
Mean monthly flour milled (ton/ month):
( ) Small scale mill (up to 300 ton/day)
( ) Medium scale mill (between 300 and 1000 ton/day)
( ) Large scale mill (more than 1000 ton/day)
Mean monthly flour milled for bread making (ton/month):
Mean monthly flour milled for domestic use (ton/month):
Mean monthly flour milled for pasta making (ton/month):
Continue
70
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
Table 1. (Continued)
Items Associated with Flour Fortification
Yes
No
N/A
Dosing equipment is readily accessible:
Automatic linkage system stops the micronutrient feeders should the flour line stop, and vice versa:
Micronutrient bins on the feeders are marked with minimum and maximum levels of the mix:
Feeders are fitted with sensors or alarms to detect when the micronutrient mix is outside the required levels and
requires correction or refilling:
Load of micronutrient mix is within the minimum and maximum volumes of the feeders:
Load of micronutrient mix exhibits arching-flow or funnel-flow patterns in the hopper:
(
) Screw-feeders
(
) Other (specify):
Brand name and address of the feeder manufacturer(s):
Volume added by feeder is recorded:
Frequency of measurement of volumes of flour and micronutrients is satisfactory (i.e. every 2 h or 4 times per shift):
After analysis of micronutrient outflow, the volumes are corrected manually:
After analysis of micronutrient outflow, the volumes added are adjusted automatically and electronically:
Calibration curves exist for each micronutrient mix and their respective feeders in order to assist with the correction of volume errors:
Producers of micronutrients have provided evidence of their compliance with GMP and appropriate validation of homogeneity of the formulation:
After changes in the formulation of the micronutrient mix, the feeders are recalibrated to allow for alterations in the physicochemical
characteristics (density, fluidity, concentration) of the new mix:
Monitoring of the volumes of micronutrients and flour added is carried out by workers of proven competence:
A record exists of the use of the mix, comparing the quantities of micronutrients used with those of flour produced in a determined time:
Cleaning and removal of incrustations from the feeders is carried out periodically and each operation is recorded:
Type of iron used:
[ ] dehydrated (dry) ferrous sulfate
[ ] ferrous fumarate
[ ] reduced iron
[ ] electrolytic iron
[ ] sodium iron EDTA
[ ] iron bis-glycine chelate
Type of flour:
( ) bread-making
( ) domestic use
( ) pasta / biscuits
( ) other industrial uses
Name of micronutrient provider:
The micronutrient dosing points are currently located at:
The micronutrient dosing points are situated sufficiently far from the packaging module to allow good homogenization:
Tests have been conducted using different micronutrient dosing points and the results have been recorded:
The stock of micronutrient is adequate and located close to the dosing point:
The micronutrients are stored appropriately in the raw materials depository:
Continue
71
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
Table 1. (Continued)
Quality Control of the Final Product
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Semi-quantitative measurements (color tests) of iron in the final fortified product are performed and recorded:
All actions to correct iron concentration in the final product are recorded:
Reports are available of all analyses carried out in recent months by a validated laboratory showing iron and folic
acid concentrations in all lines, especially those destined for bread-making flour:
Labels
Show the name of the vendor and information relating to fortification:
Show essential nutritional information – e.g. 1/2 cup = household measure = 50 g flour provides 2,1 g iron (15%
daily value) and 75 μg folic acid (31% daily value):
Documentation
GMP manual available for reference:
Operations are carried out in accordance with the GMP manual:
Official receipts of purchase of micronutrients are available and relevant reports from a validated laboratory are
provided by the producer verifying the levels of iron and folic acid for each lot:
Reports available from a validated laboratory verifying the levels of iron and folic acid:
Reports available from a validated laboratory verifying granulometry (Tyler mesh 325) of reduced, electrolytic or
carbonyl iron in the micronutrient mix:
Laboratory report available verifying humidity of the stored micronutrient mix:
Reports available from a validated laboratory verifying the levels of iron and folic acid in the flour or final products (mixtures for bread making):
Existence, compliance and record of SOP for flour fortification with iron and folic acid:
N/A – not applicable
72
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
Table 1. (continued)
SOP for Wheat Flour Fortification
The wheat milling industry should describe how the fortification technology functions (volumetrically or gravimetrically) and should make
available standard procedures for:
• the maintenance of dosing equipment, with details explaining how to deal with the problems most frequently encountered;
• the measurement of outflows of flour and micronutrients during production, and the recording of this information;
• the calculation of micronutrient dose employing spreadsheets that are easily interpreted by the workers;
• refilling feeders with micronutrients and recording the time intervals;
• the provision by the micronutrient producer of reports of analyses of iron and folic acid levels carried out by validated laboratory;
• the provision of reports of analyses of iron and folic acid levels in the micronutrient mix carried out using validated methods in a
qualified laboratory chosen by the mill;
• the provision of reports of analyses of iron and folic acid levels in flour and mixtures for bread making carried by a validated laboratory
at the time intervals specified in the following section.
Sampling, qualification of analytical laboratories, presentation of analytical reports, and frequency of analysis of iron and folic acid
levels in flours and bread-making mixes
The sample should be composed of the production lots from one day and should be collected in the packaging area from a determined production line. Mills should elaborate specific sampling plans for their production lines. The health authority may establish a different sampling
routine according to the GMP in place at the mill.
Analytical reports should identify the lots of flour or fortified products, the date of production, the name of the micronutrient mix and the
lots used in that sample.
The analytical laboratories must apply appropriate Good Practice and employ trained analysts, validated analytical methods and proficiency
tests for iron and folic acid analysis.
Small scale mill (up to 300 ton/day):
Analyze 1 flour sample per month and alternate the various production lines (if more than one exists) each month.
Medium scale mill (between 300 and 1000 ton/day) and large scale mill (more than 1000 ton/day):
Analyze 1 flour sample per month for each 300 ton milled/day and alternate the various production lines each month.
CONCLUSIONS
Place, date and signature of auditors.
73
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
term for the cultural material of a particular people”19
and is based on a few key informers selected for their
competence and logical views regarding the study
culture, rather than on a representative sample group20.
The method of participative observation for the
accession of field data is critical in ethnological research
since it involves the establishment of relationships with
a particular community. The researcher collects data by
participating in the daily life of the group or organization
under study, and by observing people and situations and
interpreting the behavior observed. This technique brings
the researcher closer to the native language of the social
group under study and allows him/her to understand
their culture intuitively and to speak with confidence
about the significance of the observed data. Occasionally,
field circumstances may allow a number of similar events
to be observed or similar questions to be put to a number
people in a systematic approach, thereby yielding
data with a quasi-statistical foundation and providing
conclusions regarding frequency or distribution21.
The present study revealed that the participating
mills had already implemented some form of GMP and
employed many of the controls reported in the literature
and outlined in the present paper. Furthermore, the
managerial staff demonstrated significant involvement in
the elaboration of the GMP checklist and interest in the
results obtained.
The GMP checklist for flour fortification
developed by our research team includes items extracted
from the scientific literature and governmental health
legislation documents, as well as from the reports on
the observations performed in the milling industries.
Information concerning critical control points and the
use of inspection checklists for the flour fortification
process were available in the literature and included
aspects such as the quality and storage of micronutrients,
the frequency (once per shift) of verification of feeder
dosages, the frequency (daily) of product sampling for
micronutrient analysis, and the maintenance of records
of all procedures, problems encountered and proposed
corrective actions6. Some authors have suggested GMP
inspections by health authorities every three to six
months5.
In agreement with MI22, and Brasil23, Buzzo et
24
al one of the key items included in the GMP checklist
related to the dosage and control of micronutrients.
Considerable variation was observed between the mills
regarding the micronutrient dosing systems employed,
74
and this reflected the concern of the company with
respect to flour quality and the level of investment
made. A few companies had installed automatic dosing
systems with electronically adjusted rates, although the
majority relied on mechanical and less precise systems
that generally lacked warnings about potential faults and
procedures for troubleshooting.
Perhaps unsurprisingly, inspection of company
records revealed a wide variation in the concentration
of micronutrients in the flour samples analyzed. Such
discrepancies may be attributed to the lack of adequate
maintenance of equipment, particularly of non-automated
dosing systems, which is essential for system reliability
and safety. The point at which micronutrients were added
to the flour within the production line was also found
to constitute an important checkpoint. For example, a
mechanical dosing device could be incorrectly positioned
such that the mix of micronutrients and flour was uneven,
giving rise to a product that was non-homogenous in
terms of hygroscopicity, fluidity and particle size. With
automated dosing systems, micronutrients and flour
were typically homogenized effectively with only small
variations being detected between four consecutive
samples. Automated systems were of the continuous,
gravimetric and electronic type, or of the batch type with
a gravimetric feeder and a Y-shaped mixer that provided
good homogenization. In some of the mills inspected, the
feeders were difficult to reach since they were located at
the top of a long or difficult stairway.
Concerning the variability in the level of
investment in modern process systems for flour
fortification, it is worthwhile emphasizing a key
characteristic of the Brazilian wheat industry. Until 1990,
the buying and selling wheat was under the government
control (subsidized by the government). Thus, the
industry has had only two decades to adjust to the free
competitive global market. Moreover, Brazil depends to a
large extent on imported wheat since national production
is insufficient to meet the qualitative and quantitative
needs of the country. Therefore, the price of wheat flour
in Brazil is very much dependent on the fluctuations of
the international commodity market.
The origin of the micronutrients employed in
flour fortification exerts a considerable influence on the
quality of the final product. Numerous factors must be
taken into account when appointing a micronutrient
supplier, amongst which are: the type and granulometric
characteristics of the iron, the quality of the formulation,
Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
the quality and hygroscopicity of the iron carriers and the
quality of the laboratory analysis to ensure appropriate
iron formulations. Low quality formulations of
micronutrients were encountered during the inspections,
especially with respect to the granulometry of the iron
particles, the fluidity and balance of the formulation,
and the questionable quality of some analytical reports,
which appeared to contain non-reproducible results.
The frequency of product sampling and the
techniques employed in collecting samples differed
from one company to another. Since laboratory analyses
increase the costs of the milling operation, the number
of analytical procedures performed is often insignificant
in terms of the total volume of flour produced. The
final GMP checklist proposes a standardized sampling
procedure based on the daily production of flour, and
requires the mill to provide monthly reports containing
the results of iron and folic acid analyses for each 300 ton
lot of flour produced each day. The classification of the
scale of the mill, which determines the sampling routine,
was observed during the field project and the frequency
of sampling suggested takes into account the analytical
costs. Improving GMP would remove the necessity for
excessive product analyses.
In this context, the GMP checklist for the salt
industry published in the annex to Resolution RDC no.
28 issued by14 includes the minimum obligatory controls
for salt iodination, such as the quality and storage of the
micronutrient, preparation and addition of the iodine
solution, control of the solutions and feeder addition
rates, the point of application of iodine during the salt
production process, the responsibilities of the workers,
salt sampling for analysis of iodine in the final product
and the complete records of the whole process (log book).
However, information relating to the flour
fortification with iron and folic acid, as presented in the
present study, is scarce. Lopes, Franco25 monitored GMP
in three wheat mills at the grain milling stage, and noted
the effects on the microbiological quality of the final
product. Frequent cleaning of equipment and the use
of bleach with 100 ppm of free chlorine improved the
quality of the process and of the product. In the present
study, controls to improve the quality of flour fortification
were incorporated.
Additionally, Tavolaro et al26, used Resolution
RDC nº 275 issued by ANVISA13 to evaluate hygienic
practices in the milking of goats in three farms located in
the State of São Paulo. The authors interviewed the dairy
workers before and after they had received instruction
on operational hygiene and subsequently analyzed the
collective discourses. In this case, however, training in
hygienic practices did not give rise to changes in the
routine procedures carried out by the workers.
CONCLUSION
Quality control of fortified flour is fundamental
if the governmental strategy is to produce a positive
and permanent impact on the prevalence of IDA in
the Brazilian population. The ethnographic method
employed in observing the daily practices of flour milling
was appropriate since it allowed the collection of a
considerable amount of information regarding the routine
work in the mills, including the performance, protocols,
conduct, language and technology employed by the
personnel. Furthermore, it was possible to confirm that
the protocols and controls employed in the industry varied
considerably from one mill to another. The investigation
resulted in a GMP checklist and a recommended SOP
that is specific for the flour fortification industry. This
GMP checklist will not only help to standardize the
currently incongruent production processes but will
also facilitate the work of government health inspectors.
Since the GMP checklist developed by our research team
derived from observations at dissimilar settings, it will be
readily adaptable for use in the majority of flour mills in
Brazil. However, it is important that the GMP checklist
be submitted to critical analysis by ANVISA in order to
validate its extensive application. Finally, the results and
the experience accumulated in the National Program for
Prevention and Control of Iodine Deficiency Illnesses
should inspire the creation of a similar program for the
prevention of IDA, since the GMP checklist for flour
fortification presented herein is similar to that issued by
ANVISA14 for salt fortification.
ACKNOWLEDGEMENTS
The authors wish to thank the inspectors of the Health
Surveillance Center of the Health State Department of
São Paulo, the managers of the wheat mills who allowed
the development of this research and other collaborators
who assisted with the study and Fabiana da Silva Lima for
technical revision of the text.
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Latorre WC, Colli C. Good manufacturing practice in Brazilian wheat mills with particular reference to the flour fortification Rev Inst Adolfo Lutz.
São Paulo, 2014; 73(1):67-76.
REFERENCES
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