Capsules, as solid dosage forms, encapsulate drug formulations in various states – powder, solution, suspension, or liquid – within a shell.
The formulation and filling of capsules involve extensive quality control testing to ensure they meet industry standards. These tests occur in three phases: process testing, finished product testing, and shelf life evaluation.
Quality of Raw Materials
Understanding the quality of raw materials, including their origin and the traceability of suppliers and supply chains, is critical. Suppliers of raw materials undergo thorough audits, assessing their industry knowledge, manufacturing process technologies, supply chain, packaging capabilities, and compliance with Good Manufacturing Practice (GMP).
Particular attention is paid to the origin and risk factors of raw materials like gelatin and HPMC. This involves on-site audits and batch testing for functionality and stability, ensuring the quality of key ingredients.
It’s important to note that capsule manufacturing ingredients. For example; colorants, which are typically safe, but must comply with evolving regulations in various markets.
Control Manufacturing and Finishing of the Product
Quality control is paramount in pharmaceutical manufacturing, covering the entire process from raw material receipt to final product release. This process adheres to guidelines from the World Health Organization (WHO), Eudralex in the European Union, the United States Pharmacopeia (USP), and the International Council for Harmonisation (ICH).
Therefore, regular quality tests during capsule manufacturing are crucial. These include monitoring capsule thickness, uniformity, seal thickness, filling, shell weight, moisture level, and conducting visual inspections.
Completed capsules undergo tests for permeability, sealing, potency, impurity content, weight variation, content uniformity, dissolution, moisture content, and more, to ensure they meet the required standards and regulatory requirements.
Ultimately, these meticulous processes determine the suitability of a capsule batch for sale or its intended purpose.
FOREFRONT Nutraceuticals, with its extensive stock of capsules in sizes #000, 00, 0, 1, and 3 in both HPMC and Gelatin, located in The Netherlands, exemplifies the rigorous standards and practices essential in capsule manufacturing. Our commitment to quality and safety ensures that every product meets the highest industry standards.
