FROM CONCEPTUALIZATION TO COMMERCIALIZATION
CERTIFIED FDA REGISTRED FACILITY
QUALITY & COMPLIANCE
We have adopted the “Quality by Design” approach to ensure quality is built into the product by assuring each step of the process, from product development to shipping out, is verified by our trained Quality Assurance staff. We support our customers with any quality and compliance-related questions even after the product is shipped out.
Our trained QA team ensures that each step of the manufacturing and packaging operations is verified, and appropriate documentation is completed before moving to the next step.
We believe in the best quality and always go above and beyond to provide the highest quality products and services to our customers for dietary supplement products. We strive to meet or exceed our customers’ expectations by delivering consistent, safe, and pure products with skills, hard work, and sheer passion.
Our commitment is not limited to certifications. Every product we produce at SMK is developed very carefully by a team of highly qualified product development scientists. Each selected ingredient is of the very best quality for maximum nutrition and the most delicious product in the market, whether they are organic, kosher, gluten-free, vegan, or otherwise.
QC LAB &
3rd PARTY LABS
ANALYTICAL, MICROBIAL, STABILITY TESTING
RETAIN & RESERVE SAMPLES
ALLERGEN CONTROL PROGRAM,
QUARANTINE & RELEASE PROCESS
ENVIROMENTAL MONITORING PROGRAM
SOME EXAMPLES OF IN-PROCESS
QA VERIFICATIONS INCLUDE:
Verification of the ingredient COAs
Verification of ingredient weighing and pre-batch staging
Equipment and room clearance before production
Verification of batch record documentation
Compilation of all relevant documents
In-process checks (i.e. weight variation, metal detection, etc.)
Final pallet verification prior to shipment
Allergen verification in every step of the process by documentation and product/ personnel isolation practices.
FDA REGISTERED FACILITY
We put product safety and quality above everything else. We have achieved this by incorporating industry-leading current Good Manufacturing Practices (cGMP) in our sourcing, purchasing, manufacturing, and packaging operations. We are an FDA-registered Manufacturing Facility.
NSF GMP REGISTRATION CERTIFICATION
NSF International is a leader in GMP food safety audits and certifications for manufacturing facilities. SMK Global is proud to have earned “GMP Registration Certification” and “Certified for Sport Certification” from NSF International, for outstanding quality standards and practices through a set of rigorous audit processes. that follow NSF/ANSI 173, Section 8 which includes FSMA and cGMP (21 CFR 111), (21 CFR 117).
NSF - GMP FOR SPORT
The audit process for “Certified for Sport Certification” follows NSF 306, Section 6 (GMP for Sports Requirements). By meeting this product-based requirement, it gives our customers, and athletes/sports personnel an assurance of avoiding cross-contamination from all WADA-banned substances.
QAI ORGANIC CERTIFICATION
Quality Assurance International (QAI) is a USDA-accredited, globally operating, and one of the leading certification agencies for Organic Certification to National Organic Program standards. SMK Global has earned organic certification from QAI by exhibiting the supply chain controls and material handling during manufacturing and packaging operations to maintain the organic integrity of the products.
SMK Global has successfully completed the facility inspection from OK Kosher, one of the widely recognized kosher certification agencies by demonstrating sound practices, followed to ensure all ingredients, derivatives, tools, and equipment have no trace of non-kosher substances in Kosher certified products.
GMP NJ GOOD MANUFACTURING PRACTICES
Additionally, we are certified for Good Manufacturing Practices (GMP) by New Jersey Department of Health, Consumer, Environmental and Occupational Health Service following a successful inspection.
We take consumer safety very seriously when it comes to allergenic ingredients, WADA-banned substances, and pathogen testing in our facility. All allergenic ingredients are distinctly identified with color-coded labels for each specific major food allergen as per the Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA).
Validated equipment cleaning, and cleaning verification swab sampling processes are employed after manufacturing a product containing any food allergen to ensure that allergen is not carried over to the next product. We are committed to not purchase any banned substances as listed by WADA (World Anti-Doping Agency).
ENVIROMENTALL MONITORING PROGRAM
Additionally, to provide safe and pure products, we have established an excellent Environmental Monitoring (EM) program by employing the prerequisites, such as Air Quality Program, Water Quality Program, Preventive Maintenance Program (Internal & External), Calibration Program (Internal & External), Equipment & Facility Cleaning and Sanitization Program.
These programs are verified by using various air, water, and surface sampling and testing protocols. Our EM program ensures that all equipment and production areas are suitable for operations. We have qualified and employed some of the most advanced technologies for this purpose, such as SAP-based ERP system, 3M food safety, Vaisala Data Loggers and ViewLinc system.
IN HOUSE QUALITY CONTROL LAB
All dietary ingredients we purchase, and the finished products must undergo a set of established quality analyses at our in-house state of the art Quality Control Laboratory.
Raw ingredients are quarantined until tested and released. Raw ingredients and finished products are tested against established specifications.
We maintain a reference library for all ingredients and finished products on site. Reserve and retain samples of all dietary ingredients and finished products are collected and stored on-site for compliance, and continuous and future improvements in product formulations.
PARTNERSHIP WITH QUALIFIED TESTING LABS
We also have qualified third-party laboratories that can perform a wide range of testing for us who have many years of extensive experience in dietary ingredient and supplement testing.
Our testing capabilities include:
Identification and other physical Testing
Chemical / Analytical Testing
Stability (Shelf-Life) Testing
QUALITY DEPARTMENT GLP & GDP PRACTICES
Along with ingredients and finished products, all packaging components are also analyzed against their established specifications prior to release. Finished products are released after receiving acceptable analysis results and a certificate of analysis for each batch/lot is issued.
Our quality department is trained to follow all SOPs, use accurate, scientifically valid, and reliable test methods along with employing current good laboratory practices (GLP) and good documentation practices (GDP) to produce reliable data for total quality management.