Centre of excellence
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 areas. Ingredient preparation and solution compounding is performed in a Class 100 (for sterile products) and Class 100000 (for oral products) processing areas in adherence to the current Good Manufacturing Practices (cGMP).
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Active pharmaceutical ingredients
Scotmann directly procures only the highest-grade APIs having not less than 90% shelf life from proven and reputable sources. All our API suppliers have to go through a stringent vendor qualification process, by way of a multi-step investigation process, which includes all aspects of production, handling procedures and packaging in order to ensure the highest level of final product quality.
Formulations
Scotmann’s formulations are developed by highly skilled and experienced team of professionals, The formulations are subjected to internationally accepted stability testing protocols to meet the standards of quality and efficacy. The products are 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 GMP procedures.
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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. APIs are quarantined and tested for identity, In-process materials are tested for ingredient accuracy & formulation potency, and the final product is quarantined and tested to ensure that the product is in compliance with all formulation specifications, meeting international standards for purity and potency.
Quarantine & 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 analyses ensure the API is of the right grade, purity and free from bacterial contamination or other toxins. The material is only released after it has been thoroughly tested and inspected at multiple levels and receives 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. 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.
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.
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 Products
Whether producing a product with one API 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 consumers receive only the highest quality medicines that exceed industry standards and provide exceptional therapeutic benefits.
