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State-of-the-Art Manufacturing

Scotmann’s manufacturing processes are contained within complete HEPA/ULPA ceiling Class 100 “Clean Rooms” supported by a series of class 10000 and class 100000 “Service Rooms”. Ingredient preparation and solution compounding is performed in a Class 100 (for sterile products) and Class 100000 (for oral products) processing areas. All operations comply with current US FDA Good Manufacturing Practices (GMP).

Raw Materials

Scotmann directly purchases only the highest-grade raw materials having not less than 90% shelf life from proven and reputable sources to be put into product formulations. All raw material suppliers go through a stringent vendor qualification process, which includes a multi-step investigation including all aspects of the production, handling procedures and packaging, to ensure the highest level of product quality.

Formulations

Scotmann’s formulations have been developed through a highly skilled and experienced team of professionals who make up the core of our R&D department, the formulations are subjected to internationally accepted stability testing protocols to meet the standards of quality and efficacy. The products are, then, manufactured in state-of-the-art facilities to deliver unsurpassed purity and quality. Each manufacturing section at Scotmann goes through rigorous qualification measures to ensure high standards and that each batch is prepared according to stringent GMP procedures.

Quality Control

Each product at Scotmann undergoes strict quality control checks and testing procedures before reaching the consumer. At each stage of the manufacturing process, the product is tested and controlled. Raw materials are quarantined and tested for identity, in-process materials are tested for ingredient accuracy and formulation potency, and the final product is quarantined and tested to ensure that the product is in compliance with all formulation specifications, and meets all international standards for purity and potency.

Quarantine and Inspection Procedures

In order to ensure that every material received is pure and unadulterated, it is quarantined after being received at the factory. The material is inspected and tested for identity. It is made sure that the product is exactly what the product formulation requires. Lab analysis ensures the product is of the right grade, purity and free from bacterial contamination or other toxins. The material is only released after the product has been thoroughly tested and inspected at multiple levels and receiving the final confirmation from the Quality Assurance (QA) Department.

Processing

Once an ingredient is approved by (QA) for processing, the product goes through multiple control points throughout the production process. Extensive documentation takes place throughout the processing stage in order to verify each process was done according to the Master Manufacturing Record and meets cGMP guidelines including traceability. State-of-the-art equipment is used to blend the in-process material in capsule, tablet or ampoule form. Once the product has been encapsulated, tableted or ampouled, the product is inspected, weighed and measured to ensure that the product meets the manufacturing specifications of the formulation for potency and uniformity and the product is safe and unadulterated. If the product is found to be out of specification by QA, the batch is rejected and a material review is performed to check all control points and determine the cause of error. When the product is approved by QA, it is packaged and labeled using the same degree of control points used throughout the process to ensure product safety for consumption and sealed from outside contaminants. Documentation throughout this process, verified by QA, includes a master manufacturing record, production batch records and a finished product Certificate of Analysis. All these steps help verify that the finished product has met all product specifications for identity, purity, strength, composition and limits.

Sanitation

Sanitation is a vital component of producing high quality products, which is why Scotmann conducts periodic as well as random inspections of all its manufacturing sections. Each machine is inspected and thoroughly sanitized with pharma and food grade cleaning agents which are backed by Material Safety Data Sheets (MSDS). After each batch passes through a machine, the machine is inspected, sanitized and protected from any possible contamination in order to ensure the equipment is safe and sanitarily fit for the next batch. Scotmann also pays special onus on personal hygiene and sanitation.

Testing

Scotmann uses state-of-the-art analytical equipment for testing raw materials, inprocess materials and finished products. Our laboratories use scientifically validated testing methods and verify the appropriateness of each test being performed. Testing protocols are based on British Pharmacopoeial, United States Pharmacopoeial, European Pharmacopoeial and Japanese Pharmacopoeial Standards. It also includes the use of sensitive analytical equipment such as High Performance Liquid Chromatography (HPLC), Infra Red Spectroscopy (IR), Gel Permeable Reverse Phase Chromatography, FT-IR and ELISA analyzers. Our extensive testing process verifies identity of raw materials, ensures potency of the product and confirms purity of all components along with ensuring compliance with all limits for microbes, heavy metals and contaminants.

State-of-the-Art Water Purification System

Scotmann’s water purification system combines double Reverse Osmosis (RO) and ultra pure water technology for the production of high quality ultra pure sterile water. The system automatically monitors the purity and sterility of water and trips itself in case of a non-compliance.

Finished Product

Whether producing a product with one raw material component or many, each finished product is held to the highest cGMP standards and produced under rigid quality control parameters to ensure product safety, potency and uniformity. Our rigorous quality assurance and control processes ensure that our patients receive only the highest quality medicines that exceed industry standards and provide exceptional therapeutic benefits.

Quality Policy

At Scotmann high quality selected ingredients, dedicated professionals and non compromising standards complement each other in producing quality products comparable to any international standard. As a privately owned, independent entity, we supply only through a carefully selected network of distributors and retailers. We all depend on the integrity of the people and products with whom we deal. Since the day we went into business, Scotmann has pledged itself to that policy. The bottom-line is, if Scotmann manufactures it, it’s a proven high quality product.

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