Reference standards are the cornerstone for potent active pharmaceutical ingredients acceptance. Each pharma client follows mandatory standards applicable to their country for production of medicines in any form. Simson Pharma has a complete laboratory to measure each feature to match the standards with best practices. We conduct lab testing to meet a country’s regulations and that of the client as a certified exporter.
Several methods are used for analysis and assessments with respect to potency quality, impurity, safety. Each medical product has a unique standard for testing on a continuous basis. This procedure is critical to ensure product acceptability in the country where the client is based. We try to make it suitable worldwide if the need arises. This makes our valuation essential for making tablets, capsules, oral medication, liquids and syrups.
Quality of testing APIs
The strength of api for pharmaceuticals is dependent on primary and secondary reference standards is well known. Tests are conducted for impurity of substances for validity of the effectiveness. Samples are matched with other unknown substances and material composition to check contamination before the production is scaled up.
Compliance towards cGMP and stamp of approval
There is an entire documentation required for a pharma company involved in manufacture of APIs. FDA, the main authority allows companies to fulfill their obligations towards the processes required. We supply samples with proper documentation to USA clients with compliances. Our regulatory work is dedicated towards fulfilling the client’s brief so that their business sees growth. As medicines are for human consumption, compulsory care is taken to ensure quality for preclinical trials, studies and traceable products.
Our lab staff is trained regularly to follow SoPs and best practices.
Proper documentation is essential for:
- Traceability and manufacturing processes api in pharmaceutical industry.
- SimSon Pharma ensures development, distribution, maintenance and control.
- Keeping project batch records for each client is important for inspections by regulatory authorities.
- Multiple database is created for step-by-step manufacturing procedures.
Cost saving when outsourcing reference material standards
Many countries choose Asian manufacturers specially in India for cost-savings. The end goal of all pharma companies is to release their products in the market quickly and step up the demand when needed by consumers. If there are impurities in the scale up production it can be disastrous. Hence, choice of the right reference standard company makes the difference to a brand’s image.
