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.
UL Over-the-Counter (OTC) Drugs Certification
The purpose of the UL® Retail Certification Program is to assess the extent to which an organization conforms to the applicable regulations and/or standards regarding the products being manufactured. Apotheca has successfully achieved and maintained certification since 2014, following inspection of its good manufacturing practices and quality system in conformance with UL’s certified management system 21 CFR Part 210/211. The scope of certification includes the manufacturing, packaging and warehousing of homeopathic liquids, homeopathic gels and creams and homeopathic tablets.
NSF Certification – Good Manufacturing Practices for Over-the-Counter (OTC) Drugs
Apotheca’s facilities are certified as conforming to all of the requirements of the NSF/ANSI 455-4 (OTC Drugs) standard, which is based on 21CFR Parts 210/211, 21CFR Part 11, 21CFR Part 7 Subpart C & ICH Q1, Q7 and Q10. NSF/ANSI 455 GMP standards are designed to strengthen safety, quality, and trust through the supply chain, as well as combine the regulatory requirements with retailer quality requirements.
The scope of this certification includes manufacturing, packaging, warehousing and distribution of OTC drug products.
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.
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.