Safety starts with quality control.
Steroids undergo quality control in multiple stages. They begin by verifying the origin of the materials they have purchased. Source verification involves the process of guaranteeing the initial supplies come from reliable vendors and meet specific quality criteria. This may include transaction and logistic verification procedures.
Once the materials are in the lab, the facility moves on to the second stage, purity testing. This is to ensure raw materials are 100% free of impurities. Materials undergo thorough testing to ensure the accuracy of their components. The quality of materials is confirmed to be 100% before moving on to the production stage, which follows standard operating procedures enforced by the law. Process control ensures uniformity in quality for every unit produced. During the production stage, there are multiple milestones set for micro-process monitoring and active reporting of parameters from temperature to pH level at each step. Recorded and analyzed to ensure each unit is produced within specified ranges.
Identyfying The Chemical Components
High-performance liquid chromatography is used to identify the ingredients of the stedoid mixture. Most pharmaceutical companies utilize it widely for safety reasons. The Process (HPLC—Coming Soon) in another article.
Nuclear magnetic resonance is also a method used to confirm the identity and concentration of a product. Most facilities have a microbiological testing department that conducts the analysis of microbial contamination, a legal requirement to guarantee sterile products.
In short, the process is:
• High-performance liquid chromatography identifies mixtures and ingredients.
• Nuclear magnetic resonance confirms product identity and concentration.
• The microbiological testing department handles microbial contamination analysis for sterility.
Testing the stability of the product is also done to maintain storage safety under different temperature and pressure conditions. This process can take months to ensure accurate results. Stability and compliance departments usually have to take two major things into consideration. Primarily the stability of the product but also the regulatory compliance like good manufacturing practices along with proper documentation of each step taken along the line to ensure safety of use.
Regular quality assurance is conducted at every facility. Extensive audits and inspections that involve strict preventative actions, such as CAPA.
