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Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

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Open Access Full Text Article                                                  Research Article

Formulation of Functional Food Supplements: Case Study of Manufacturing Process Optimization at ‘Sarepta Production’, Burkina Faso

Mimtiri S. ZONGO,¹ Luc ZONGO,^1,2,3 Modeste W. OUEDRAOGO,¹ Salfo OUEDRAOGO,*⁴ Rosemary R. CANFUA,⁵ Heiko LANGE,^6,7 Lucien KABORE,¹ Wilfried F.P. TRAORE,¹ Yilédoma T. M. LENGANE,¹ Davy P-W BEMBAMBA,¹ Aline F. TIENDREBEOGO, ⁸ Elie KABRE. ^9,10

1. Hôpital Saint Camillus de Ouagadougou (HOSCO), 09 BP 444 Ouagadougou 09, Ouagadougou, Burkina Faso. 
2. Faculté des Sciences de Santé, Université Saint Thomas d’Aquin (USTA), 06 BP 10212 Ouagadougou 06, Burkina Faso.
3. Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA) 01 BP 216 Ouagadougou 01. Burkina Faso.
4. Département de Médecine et Pharmacopée Traditionnelles-Pharmacie (Mephatra-PH), Institut de Recherche en Science de la Santé (IRSS/CNRST), 03 BP 7047 Ouaga 03, Burkina Faso.
5. Global Access to Affordable Essential Medicines and Safe Alternative Therapies, P.O. Box 458, Kampala, Uganda.
6. University of Milano-Bicocca, Department of Earth and Environmental Sciences, Piazza della Scienza 1, 20126 Milan, Italy.
7. NBFC – National Biodiversity Future Center, 90133 Palermo, Italy.
8. Pharmacie Saint François d’Assise
9. Agence Nationale pour la Sécurité Sanitaire de l’Environnement, de l’Alimentation, du Travail et des produits de santé (ANSSEAT), Ouagadougou, Burkina Faso
10. Université Joseph KI-ZERBO (UJKZ), Ouagadougou, Burkina Faso

 

 

Over 2,500 years ago, Hippocrates proclaimed: 'Let food be thy medicine and medicine be thy food.' This statement, from the Father of Western Medicine, highlights the fundamental role of nutrition in the promotion of health and the prevention of disease.^1–7 Indeed, the relationship between diet and human health has been consistently substantiated by robust scientific evidence.^3,5,8–12 It is well known that a balanced diet is one of the essential pillars of public health.¹³

In addition, a balanced and healthful diets contribute significantly to both immediate and long-term well-being, in the management of numerous health issues.¹ Thus, diet plays a fundamental role in maintaining health and preventing disease. Moreover, nutraceuticals are at the interface between nutrition and pharmacology and paves the way for seeking new therapeutic alternatives for the prevention of nutrition-related diseases.^14–20 

Food supplements, defined as concentrated sources of nutrients such as vitamins and minerals, are consumed to reach the normal diet and guarantee adequate intake of specific components over a defined period.¹⁴ However, the fundamental challenge is the absence of global consensus in regulating the use of category of products known variously as dietary supplements, natural health products, complementary medicines or food supplements in different countries.²¹ Another important challenge is how to harmonize and standardize these food supplements production practices.

Aside from rigorously upholding the cornerstone principle of primum non nocere in every aspect of human health management, it is imperative that food supplement manufacturing be both harmonized and standardized. Therefore, by aligning manufacturing protocols across regions and enforcing uniform specifications for raw materials, processing methods, dosage forms, labelling, and stability testing, manufacturers will minimize variability, prevent contamination, and reduce the risk of adverse interactions. In this way, harmonization and standardization serve as the practical embodiment of the primum non nocere, translating the ethical imperative of “first, do no harm” into concrete measures that protect public health. Hence, harmonization and standardization are mandatory tools in the quality control process.²²

Thus, the implementation of consistent, internationally recognized production and quality‑control standards, such as Good Manufacturing Practices (GMP), and relevant pharmacopeial monographs, can ensure that supplements not only comply with regulatory requirements, but also reliably safeguard consumer safety and well-being. In this same spirit, and in order to improve Burkina Faso’s evolution toward genuine food sovereignty, there is a growing emphasis on the valorisation and on-site processing of local agri-food products,^23,24 for instance ginger bread cookies and candies and moringa capsules.^25,26 

The dietary supplements defined as foodstuffs have the purpose to supply the normal diet and  they are a concentrated source of nutrients.^27–29 The ingredients constituting food supplements can be plant compounds substances with a nutritional or physiological effect additives, flavourings and processing aids.^30–34 Therefore, in the manufacturing process of food supplements, the selected ingredients are integrated into the excipients. Then, the homogeneous mixture obtained is presented in a galenic form and marketed with the opinion of the Directorate General for Competition, Consumer Affairs and Fraud Control (DGCCRF). 

This manufacturing process should be precise and enriched at each step by quality controls.^30,35,36 In fact, when coupled with harmonized, standardized manufacturing practices in‑situ processing can ensure that locally produced foods and supplements meet rigorous safety and quality benchmarks. However, the harmonization and standardization of the production of Dietary supplements remain a major challenge worldwide and in Burkina Faso in particular. Therefore, the main objective of this work is the implementation of a harmonization and standardization procedure in order to optimize the manufacturing practices of four food supplements in the production unit called ‘Sarepta Production’ in Ouagadougou, Burkina Faso.

The production of food supplements was performed at ‘Sarepta Production’, a production unit in Burkina Faso, created in 2019, for the promotion of natural products, specializing in the design, processing and enhancement of plant-based products. The microbiological tests of the finished products obtained were carried out at the Directorate of Food Control and Applied Nutrition (DCANA), of the National Agency for the Health Safety of the Environment, Food and Health Products (ANSSEAT). 

 Laboratory Materials and Equipment

The laboratory was equipped with precision weighing tools, production and sterilization equipment (water baths, autoclave, ovens), refrigeration units, and quality control instruments (pH meter, colony counter, laminar flow hoods). It also includes tools for supplement preparation (grinders, mixers, packaging devices) and essential glassware for microbiological procedures, ensuring accurate, sterile, and controlled experimental conditions.

 Study Methodology

Protocols and Processes of Dietary Supplements

This involved the writing and development of protocols and procedures for the manufacture and harmonization of production practices for the four food supplements i.e., Tonus Powder, Moringa Nutri Plus Energy, Moringa Nutri Mix with Parkia Biglobosa (Soumbala) Seeds and Ginger Sweetener, at ‘Sarepta Production’, according to GMP and GHP guidelines.

Powder production process

The production of powders for the manufacturing of food supplements was carried out using processes written within the ‘Sarepta Production’ unit. The main steps of the production process are reception of the raw materials, storage of the powders, manufacturing, i.e., drying, grinding, mixing, and sifting, awell as packaging, labelling and storage of the final products. All these steps are carried out under quality control, in order to minimize the cross contamination as well as the microbial contamination.

Preparation of culture media

Plate Count Agar (PCA) culture medium: 11.75 g of PCA is diluted in 500 mL of distilled water. The pH of the resulting solution is adjusted (pH = 7.0 ± 0.2). The solution is sterilized in an autoclave at 121°C for 15 minutes. After the autoclave, the solution is cooled in a water bath to 45°C.

Violet Crystal Neutral Red (VCBL) Bilinked Lactose Agar Culture Medium: 20.25 g of VRBL was dissolved in 500 mL of distilled water. The solution is homogenized. The pH is adjusted to 7.4 ± 0.2. The prepared solution is brought to a water bath at 45°C.

Glucose agar culture medium with yeast extract and Chloramphenicol (YGC): 20.05 g of YGC was dissolved in 500 mL of distilled water and then sterilized in an autoclave at 121°C for 15 min until completely dissolved. The pH is adjusted to 5.6 ± 0.2.

Microbiological Analytical Methods

The germs tested and the analytical methods employed are summarized as follows. Total Aerobic Mesophilic Flora (TMAF) were enumerated according to the NF ISO 4833:1991 standard using Plate Count Agar (PCA), with incubation at 30°C for 72 hours. Yeasts and molds were assessed following the NF ISO 7954:1988 protocol, utilizing Yeast Glucose Chloramphenicol (YGC) agar and incubated at 25°C for 5 days. Total coliforms were detected using the NF ISO 4832:1991 method on Violet Red Bile Lactose (VRBL) agar, with incubation at 37°C for 24 hours. Thermotolerant coliforms, including Escherichia coli, were quantified according to the NF V08-017:1980 standard, using VRBL agar at 44°C for 24 hours. For the detection of Salmonella spp., the NF V08-6579:2002 method was applied, involving culture on EPT, XLD, and SS media, with incubation at 37°C for 24 hours.

The abbreviations used refer to standard microbial analysis protocols: TMAF stands for Total Aerobic Mesophilic Flora; NF ISO refers to the French Standard aligned with the International Organization for Standardization; PCA is Plate Count Agar; YGC denotes Yeast Glucose Chloramphenicol; and VRBL stands for Violet Red Bile Lactose agar.

Preparation of stock solutions and decimal dilutions

• 25 g of powder was placed in a sterile bottle containing 225 ml of peptone water used as a thinner. This stock solution call Mother Solution (MS) corresponds to the 1/10 or 10^‑1 dilution according to the international standard NF ISO 6888‑1: 1999. A cascade dilution is then carried out.
• 2 mL of the MS is introduced aseptically through a sterile graduated pipette into a sterile screw tube containing 18 ml of the same diluent: this dilution then corresponds to 1/100 or 10^‑2.
• 2 mL of dilution 1/100 or 10^-2 is then introduced into a sterile screw tube, containing 18 mL of the same diluent using a sterile graduated pipette to form the 1/1000 or 10^-3 dilution.
• The other diluted stocks were obtained through the same process. The dilution was aimed to reduce the concentration of microorganisms as the cascade dilutions are carried out, in order to facilitate the reading of the analysis results.

Germ counts

The microorganisms were enumerated on solid media. In fact, the inoculation was done according to the method of mass inoculation. Using a sterile pipette, 1 mL of each dilution was introduced into a sterile petri dish into which approximately 15 to 20 mL of the culture medium was supercooled at 45°C; then the inoculum was homogenized and the culture medium by circular movements; the mixture was allowed to solidify at laboratory temperature. Then, the petri dishes were incubated at temperatures of 25°C, 30°C, 37°C, 44°C respectively for 24 hours and 72 hours. Incubation, reading and calculation of the number of germs were done according to the standards in force for each microorganism.

Total Mesophilic Aerobic Flora (TMAF)

The total flora, i.e., mesophilic aerobic flora, was enumerated according to the international standard NF ISO 4833: 1991;[37] inoculation was done on Plate Count Agar (PCA) agar medium and the petri dishes were incubated in the oven set at 30°C for 72 hours. Colonies were counted and calculated at the end of the incubation period.

Petri dishes with a content of less than 300 colonies were used to calculate the number ‘N’ of microorganisms present in the sample. The calculation was made using the colonies of two successive dilutions using the following formula: 

N: number of microorganisms per gram of product expressed by a number between 1.0 and 9.9 multiplied by 10 x (where x is the appropriate potency of 10)

SC: Sum of the colonies counted on all the boxes retained from the two successive dilutions

V: The volume of inoculum applied to each box 

n₁  : Number of boxes retained at the first dilution 

n₂  : Number of boxes retained at the second dilution 

d: dilution factor corresponding to the low dilution (the first one)

Total, thermotolerant coliforms and E. coli

Total coliforms were counted according to the NF ISO 4832:1991 ³⁷ standard and thermotolerant coliforms and E. coli according to the NF V08-017:1980 standard. Inoculation was done on Lactose Bilié agar medium with Violet crystal and Neutral Red (LBVN). The petri dishes were incubated in the oven at 37°C and 44°C respectively for 24 hours. Characteristic colonies were counted after the incubation period.

For the calculation of the number of microorganisms per gram of sample, the same formula was used. After the specified incubation period, boxes containing fewer than 300 colonies are retained after counting. This quantification will be used for the identification of E. coli. In case there are characteristic colonies.

Yeasts and molds

The international standard NF ISO 7954:1988 was used for the enumeration of yeasts and molds. Seeding was done on selective YGC medium. The petri dishes were incubated at 25°C in the oven for 5 days. At the end of the incubation period, the number of colonies was calculated. The number N of microorganisms per gram of sample was determined using the previous formula.

The search for Salmonella was carried out in accordance with the NF V 08-6579: 2002 standard. The MS was incubated with peptone water (EPT) at 37°C for 24 hours. Then, selective enrichment was done by transferring 0.1 mL of the resulting culture into a tube containing 10 mL of RV medium and 1 mL of the same culture into another tube containing 10 mL of KTT broth. RV medium at 42°C is incubated for 24 hours and KTT broth at 37°C for 24 hours.

From the culture obtained in the RV medium after incubation of 24 hours:

• The inoculation was done with a handle on the surface of a box of the first selective medium XLD;
• The same operation was carried out with the second selective medium Hecktoen.

From the culture obtained in the KTT broth, the operations described above are repeated. The cans are incubated at 37°C for 24 hours.

At the end of the incubation, the presence of characteristic colonies of Salmonella is sought, identifying these colonies by their black colour.

Criteria for Interpreting Microbiological Test Results

The criteria for the microbiological assessment of spices, condiments and similar products were used by default given the compositional similarities.³⁸ 

The interpretation of microbiological test results was conducted based on the criteria established by the National Center for Studies and Recommendations on Nutrition and Food (CNERNA, 2012). According to these standards, Total Aerobic Mesophilic Flora (TMAF) are considered satisfactory when their count is less than 5 × 10⁵ CFU/g, acceptable when between 5 × 10⁵ and 5 × 10⁶ CFU/g, and unsatisfactory when exceeding 5 × 10⁶ CFU/g. For yeasts and molds, results are deemed satisfactory if the count is below 10⁵ CFU/g, acceptable between 10⁵ and 10⁶ CFU/g, and unsatisfactory above 10⁶ CFU/g.

Thermotolerant coliforms are interpreted as satisfactory if below 10² CFU/g, acceptable between 10² and 10³ CFU/g, and unsatisfactory above 10³ CFU/g. In the case of Escherichia coli (E. coli), levels are satisfactory below 10³ CFU/g, acceptable between 10³ and 10⁴ CFU/g, and unsatisfactory above 10⁴ CFU/g.

Regarding Salmonella spp., their absence in 25 grams of sample indicates a satisfactory result, while their presence in 25 grams renders the sample unsatisfactory; no acceptable intermediate level is defined.

 Manufacturing Process

Food Supplement General Manufacturing Process

Four different food supplements were chosen for this study: Tonus Powder, Moringa Nutri Plus Energy CR, Moringa Nutri Mix with Parkia Biglobosa (Soumbala) Seeds, and Ginger Sweetener. The composition and appearance of the various supplements is shown in Figure 1.

 

 

 

Figure 1: Physical characteristics of the raw materials and finished products of Tonus Powder (A), Moringa Nutri Plus Energy CR (B), Moringa Nutri Mix with Parkia Biglobosa (Soumbala) Seeds (C), and Ginger Sweetener (D).

Figure 2 is a schematic representation of the different steps of the production of the four chosen food supplement preparations. 

Figure 2: Dietary supplement manufacturing diagram.

 

Specific Manufacturing Process

Figure 3 and Figure 4 represent the specific steps of the production of Tonus Powder Figure 3 (A), Moringa Nutri Plus Energy CR Figure 3 (B), Moringa Nutri Mix with Parkia Biglobosa (Soumbala) Seeds Figure 4 (A)and Ginger Sweetener Figure 4 (B). 

The food supplement "Tonus Powder" was made using six ingredients i.e.,baobab (Adansonia digitata) pulp powder, ginger (Zingiber officiale) root power, black peper (Piper nigrum) powder, cocoa powder (Theobroma cacao L.), turmeric (Curcuma longa L.) powder and cane, white granulated sugar (sucrose) from qualified suppliers. The manufacturing process is shown in Figure 3 (A). It results from the mixing of these different ingredients according to the defined proportions. This production process consists of three main steps, such as weighing, which takes approximately 10 minutes (based on an average of 2 minutes per ingredient); mixing, which requires 5 minutes to ensure homogeneity; and sieving, which takes about 3 minutes to achieve a uniform particle size.

"Moringa Nutri Plus Energy CR" is a food supplement consisting of a mixture of eight elements, i.e.,baobab (Adansonia digitata) pulp powder, moringa (Moringa oleifera Lam.) leaf powder, Spirulina (Spirulina platensis) powder, milk (whole milk) powder, cocoa powder (Theobroma cacao L.), turmeric (Curcuma longa L.) powder, cream of rice (Oryza sativa L.) and cane, white granulated sugar (sucrose) from qualified suppliers. The manufacturing process shown in Figure 3 (B) results in a dry mixture of a homogeneous powder. This manufacturing process involves three main steps: weighing, which takes approximately 16 minutes based on an average of 2 minutes per ingredient; mixing, which lasts 5 minutes to ensure a homogeneous blend; and sieving, which requires about 3 minutes to obtain a uniform powder consistency.

"Moringa Nutri-Mix with Parkia Biglobosa (Soumbala) Seeds" is a food supplement based containing the following ingredients, moringa (Moringa oleifera Lam.) leaf powder, ginger (Zingiber officiale) root power, turmeric (Curcuma longa L.) powder, garlic (Allium sativum L.) powder, paprika (Capsium annum L.) powder, onion (Allium cepa L.) powder and soumbala (fermented African locust bean from Parkia biglobosa) powder from qualified suplliers. The manufacturing process shown in Figure 4 (A) results in a homogeneous powder from a mixture of eight ingredients. This modus operandi comprises six main steps: weighing, which takes approximately 15 minutes based on an average of 2 minutes per ingredient; mixing for 5 minutes to ensure uniform distribution; sieving for 3 minutes to achieve a consistent particle size; grinding, which lasts 15 minutes to obtain a fine texture; and roasting, which requires 5 minutes to enhance flavor and improve microbiological safety.

Ginger Sweetener is a dietary supplement consisting of a blend of baobab (Adansonia digitata) pulp powder and ginger (Zingiber officiale) root power from qualified suppliers. The manufacturing process is represented in Figure 4 (B). This production process involves four key steps: weighing, which takes approximately 4 minutes based on 2 minutes per ingredient; mixing for 5 minutes to ensure a uniform blend; drying, which is carried out over a period of 10 hours at a controlled temperature of 46 °C to reduce moisture content and ensure product stability; and sieving, which takes 5 minutes to achieve a consistent and fine powder texture.

 

 

Figure 3: Diagram of the manufacturing process : Tonus Powder (A) and Moringa Nutri Plus Energy CR (B)

 

Figure 4: Diagram of the manufacturing process : Moringa Nutri Mix with Parkia Biglobosa (Soumbala) (A) Ginger Sweetener (B).

 

 

The manufacturing processes for each of the four food supplements have been successfully realized as described in the methodology part in Figure 2. 

The organoleptic and physical characteristics of the tested extracts are described as follows. Tonus Powder presents a dark beige color with a characteristic odor, a slightly tangy taste, and a fine powdery appearance. Moringa Nutri Plus Energy CR is identified by its fine green color, a slightly characteristic odor, a slight bitterness on the palate, and a fine powdery texture. Moringa Nutri Mix with Soumbala exhibits a Veronese green color, a slightly characteristic odor, a slightly bitter taste, and a moderately fine appearance. Ginger Sweetener is characterized by a creamy yellow color, a very distinctive odor, a spicy taste, and a moderately fine texture. Figure 1 indicates the physical characteristics of the raw materials and finished products.

3.2 Critical points and control measures 

Table I provides a comprehensive overview of the identified critical control points (CCPs), along with the specific preventive and corrective measures established to ensure process control, product quality, and compliance with applicable regulatory standards.

 

 

Table I: Critical Control Point (CCP) and control measures.

Production Operation	Type of hazard	Control measure
Reception	Containers and raw materials arriving from outside can be a source of biological and physical contaminants.	CCP1. At the reception, the reception bins are labelled (blue, green, red), and clean; clean hands, implementation of controls upon receipt of raw materials
Mixture	This operation is carried out with small equipment. Insufficient cleaning can be a source of biological contamination.	CCP2. At this stage, users must scrupulously follow the basic rules of hygiene, namely washing and disinfecting hands and utensils thoroughly before handling.
Packaging	Moisture recovery if the seals are not watertight or if the packaging is not very resistant. Proliferation of biological contaminants	CCP3. Observe the rules of hygiene and hand cleaning before packaging and choose good quality packaging and check seams.
Storage of finished product	Moisture recovery and insect infestation. It is can be a source of biological contamination.	Keep finished products on clean shelves. Avoid storing them on the ground. Avoid storage in direct sunlight to prevent deterioration of packaging material.

 

 

3.3 Finished products microbiological characterisation

The results of the microorganism count of the samples produced at different periods are displayed in Table II. In addition, Figure 4 illustrates the microbiological profile of the microorganisms investigated during the three production periods for each food supplement.

 

Table II: Microbiological Testing Results.

T: Tonus Powder; EG: Ginger sweetener; MS: Moringa nutri mix with Parkia Biglobosa (Soumbala) Seeds; ME: Moringa Nutri Plus Energy CR; FAMT: Total mesophilic aerobic flora; TC: Total coliforms; CTh: Thermotolerant coliforms; E. coli: Escherichia coli; LM: Yeasts and moulds

Figure 4: Tonus Powder (A); Moringa Nutri Plus Energy CR (B); Moringa Nutri Mix with Parkia Biglobosa (Soumbala) Seeds (C); Ginger Sweetener (D).

 

The standardization of production practices implemented at the ‘Sarepta Production Unit’ reflects a structured approach to ensure repeatability, traceability, and quality in the manufacture of plant-based food supplements. As noted by the French Agency for Standardization, establishing a clear documentary system with procedures and instructions is crucial to promoting effective internal communication and consistent quality outputs ^39,40

From raw material reception to packaging, each step was carried out according to West African Economic and Monetary Union (WAEMU) GMP guidelines. During the raw material reception stage, all incoming materials were carefully inspected and documented. This included identity verification, physical integrity checks, and compliance with predefined specifications, critical actions for avoiding contamination through foreign matter like sand or metal particles ^41–43 Proper documentation and traceability through labeled and signed delivery records ensured full conformity to quality assurance protocols.

The transformation phase followed a rigorous sequence of operations: drying, milling, sieving, weighing, and mixing. Specific attention was paid to avoiding cross-contamination, particularly with odoriferous ingredients like soumbala (Parkia biglobosa). As recommended in GMP sheet No. 5, equipment cleaning and production scheduling were optimized to prevent flavor and microbial cross-contamination, especially given that small-scale operations often rely on shared tools.^44–46

The packaging stage used sealed aluminum food-grade bags, with 25 g and 50 g formats. Heat sealing preserved the integrity of the product and minimized exposure to moisture, air, and light, factors that can degrade quality and promote microbial growth. All labels complied with Codex Alimentarius guidelines,⁴⁵ including the product name, composition, batch number, expiry date, and net quantity, thereby supporting consumer information and traceability.⁴⁷

4.2 Critical Control Points and Quality Management

Two major critical control points (CCPs) were identified: physical impurities like sand in the powders and biological hazards (microbial contamination). The physical risks were addressed through meticulous cleaning of storage containers and good hygiene practices among staff, recognizing that most physical contaminants in such environments originate from human handling ^48,49. Biological risks were mitigated by training staff on GHP and targeting high-risk ingredients, such as soumbala, with additional decontamination steps like roasting at 100°C.

The comprehensive implementation of GHP, GMP, and HACCP system aligns with best practices observed in similar contexts ⁵⁰. Although HACCP implementation in artisanal and small-scale industries is often challenged by complexity and documentation burdens, preliminary efforts in training and awareness significantly reduce microbial and physical contamination risks.^51,52

4.3 Microbiological Quality and Process Improvement

Microbiological analysis across three production cycles showed a progressive reduction in contamination levels, underlaying the effectiveness of the implemented process controls. The first production revealed moderate levels of FAMT, yeasts and molds, and coliforms, though all within acceptable safety limits. No pathogenic microorganisms, including Escherichia coli or Salmonella spp., were detected.

Subsequent production runs showed an important improvement:

• FAMT decreased from 1.7 × 10⁵ CFU/g to 3.3 × 10² CFU/g.
• Yeasts and molds dropped from 2.7 × 10³ CFU/g to 1.7 × 10 CFU/g.
• Total and thermotolerant coliforms fell from 1.0 × 10⁵ CFU/g to 0 CFU/g.

These results demonstrate an increasing level of microbiological control and process reliability, likely attributed to stricter hygiene procedures, enhanced staff training, and the use of HACCP-aligned preventive measures. Notably, the consistent absence of Salmonella and E. coli in all samples reinforces the sanitary integrity of the production process ^53,54.

Nevertheless, the detection of coliforms and yeasts in earlier batches indicates the importance of maintaining strict hygiene protocols. Coliform presence may indicate fecal contamination, typically linked to poor personal or equipment hygiene. Meanwhile, the presence of saprophytic flora and molds can impact product stability and organoleptic properties, especially if storage conditions are suboptimal ^55–57.

This study aimed to improve the quality and safety of plant-based food supplements produced at the ‘Sarepta Production’ unit by implementing standardized manufacturing practices. Drawing on GMP and GHP, the team developed and applied Standard Operating Procedures to enhance process consistency and reproducibility.

Microbiological assessments conducted on three successive production batches demonstrated an important decline in total microbial load, coliforms, and fungal contaminants (yeasts and molds), with no detection of pathogenic microorganisms such as Escherichia coli, Salmonella spp., or Staphylococcus aureus. These results highlight the effectiveness of integrating GHP, GMP, and HACCP principles in improving both the microbiological safety and the organoleptic properties of locally manufactured plant-based supplements.

The observed improvements were attributed to a continuous process of optimization and the systematic application of HACCP for identifying and controlling critical points. The study thereby contributed to the formalization of structured manufacturing protocols and reinforced the importance of documentation, personnel training, and preventive quality strategies. These outcomes are consistent with international recommendations, which emphasize that the success of quality assurance systems bases on the foundation of strong hygienic practices prior to the full deployment of advanced tools such as HACCP.

Conflict of Interest: The authors declare no potential conflict of interest concerning the contents, authorship, and/or publication of this article.

Author Contributions: All authors have equal contributions in the preparation of the manuscript and compilation.

Source of Support: Nil

Informed Consent Statement: Not applicable. 

Data Availability Statement: The data presented in this study are available on request from the corresponding author. 

Ethical approval: Not applicable.

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