USDA Certified Organic
Organic certification is a rigorous process that ensures farmers and businesses adhere to stringent standards throughout the entire production process, from cultivation to processing and distribution. When you encounter the USDA organic seal, you can rest assured that the product meets the highest organic standards, containing at least 95% organically grown ingredients. Organic agriculture prioritizes natural processes and sustainable practices, promoting a harmonious relationship between human activities and the environment.
Regulatory Compliance / Third-Party Certifications
Apotheca is an FDA registered manufacturing facility and we comply with all FDA regulations. With our extensive experience in regulatory compliance of over-the-counter products, we can advise and assist with all requirements for FDA product indications, label copy, and ingredient listings. The FDA requires that all multi-ingredient over-the-counter remedies provide symptom relief, and we are able to guide you in making the appropriate “symptom relief” claims on your packaging. We will also file the appropriate drug product listing with the FDA for all over-the-counter drug products manufactured for U.S. sales.
What is GMP Certification?
Good Manufacturing Practices (GMPs) are a system of processes, procedures and documentation to exert control of the product manufacturing to assure quality and safety of the product. These GMP standards under NSF/ANSI 455 were developed in accordance to American National Standards Institute requirements.
NSF independently certifies manufacturers as meeting GMP requirements.The program is open to manufacturers and packagers of dietary supplements, cosmetics, and over-the-counter drugs who want to demonstrate their commitment to public safety. Independent certification from the global public health organization demonstrates a commitment to dietary supplement quality and compliance with U.S. GMP requirements.
ABOUT NSF
NSF is an independent and accredited nongovernmental organization whose mission is to protect and improve global human health. We do this by facilitating the development of public health and safety standards through our Standards group, and by testing and certifying products and systems to those standards through our service groups. Certified products and systems earn the NSF mark, which is respected by consumers, manufacturers, retailers and regulatory agencies. Deeply rooted in science, we are widely recognized as the “gold standard” for quality in such areas as water systems, food safety and health sciences including dietary supplements.
Product Consistency and Reliability
At Apotheca, every step of the manufacturing process is well documented according to GMP regulations, FDA guidelines and industry best practices. With quality raw materials, standardized manufacturing processes and stringent product testing, you can count on Apotheca to consistently deliver high quality products, order after order.
High-Quality Ingredients
Product quality begins with the sourcing of high-quality ingredients. We obtain quality raw ingredients and materials from ethical and reliable suppliers worldwide. Every supplier is qualified prior to purchases being made, and every lot is tested to confirm it meets Quality approved specifications prior to release for production use. We use state-of-the art in-house USP purified water systems for all manufacturing, including homeopathic dilutions involving water
Quality Control Testing
Each lot of each shipment of incoming raw material(s) is subjected to identity and quality testing. Materials must meet Apotheca’s specification criteria prior to release for use in production.
Critical quality attributes of each batch of product produced are confirmed through routine in-process monitoring and testing as well as finished product testing. No finished product is quality released until it has passed Apotheca’s rigorous series of finished product testing per pre-established specification criteria.
Our in-house laboratory offers a multitude of ingredient/product testing services, including physical, analytical/chemical, microbiological and sensory. Apotheca’s labs are equipped with trained staff and a variety of instrumentation necessary for performing specification testing, including: FTIR (fourier-transform infrared spectroscopy), UV-Vis spectroscopy, GC (Gas Chromatography), HPLC (High Performance Liquid Chromatography), HPTLC (High Performance Thin-Layer Chromatography), Soleris® Next Generation rapid microbiology system.
