Pharmaceutical product manufacturing involves a series of complex processes aimed at producing medications that are safe, effective, and of high quality. The process typically begins with research and development (R&D), where scientists identify potential drug candidates and conduct preclinical studies to assess their efficacy and safety profiles.
Once a promising drug candidate is identified, it undergoes rigorous clinical trials to evaluate its safety and effectiveness in humans. Regulatory authorities review the trial data to determine whether the drug can be approved for commercialization.
Once a drug is approved, the third party manufacturing process begins. It starts with sourcing raw materials, such as active pharmaceutical ingredients (APIs), excipients, and packaging materials, from approved suppliers. These materials undergo quality testing to ensure they meet regulatory standards.
The manufacturing process itself involves several steps, including formulation, mixing, granulation, drying, compaction, and coating, depending on the dosage form of the medication. Each step is carefully controlled to ensure uniformity and consistency of the final product.