Capsules are solid dosage forms in which a drug formulation in powder, solution, suspension, liquid combination, or a simple liquid formulation is enclosed in a shell.
In the development of the capsule formulation and during their filling, a series of quality control tests are carried out, guaranteeing that the capsules comply with the conventional requirements established by each industry.
These tests will be discussed in three stages: the testing of the process, the finished product testing, and the shelf life testing.
Raw material quality
It is essential to have a thorough understanding of the origin of raw materials, including the traceability of each one of the suppliers and supply chains.
When choosing potential raw materials suppliers must undergo an auditing procedure. This audit shows the knowledge about the industry, the process technologies involved in manufacturing, the supply chain, and its capabilities for packaging, distribution, and other management systems that demonstrate the history of compliance with GMP (Good Manufacturing Practice).
Subsequently, the origin of raw materials and risk factors are analyzed by employing on-site audits to evidence the key ingredient origin and processes for capsule production, such as gelatin and HPMC. In addition, tests are carried out in different batches to guarantee functionality and stability, which are part of the qualification of the key ingredients to produce them.
It is important to note that the ingredients used in capsule manufacture, such as colorants, contain elements generally recognized as safe. However, although regulations in markets such as the United States, Europe, or Canada are usually similar for these components, they can also change. You should be aware of these different regulations and their constant evolution.
Controls in manufacturing and completion
The Pharmaceutical industry is committed to developing and producing medicines that improve human health through research and the development of new pharmaceutical products, which ensure quality according to international standards (IFPMA, 2014).
Quality control in the pharmaceutical industry is one of the most crucial steps to having safe and effective products. The manufacturing chain of a drug ranges from the receipt and approval of the raw materials to the finished product’s release.
Among the parameters for carrying out a regulated process are the Technical Reports of the World Health Organization (WHO); the rules and regulations governing medicines in the European Union, known as Eudralex; the United States Pharmacopeia (USP); and the guidelines of the International Council for Harmonisation (ICH).
Therefore, quality tests are of great importance in capsule manufacturing processes, which are carried out at intervals set by the staff. Subsequently, the data is recorded so that the results can serve as a guide for future processes.
These parameters allow determining characteristics that need to be considered both during the manufacturing process and in the finalization of the product.
Generally, these is the criteria that’s usually closely monitored and controlled during encapsulation of soft gelatin capsules: thickness and uniformity, seal thickness, capsule filling and shell weight, the moisture level of the shell, and a visual inspection.
Finished capsules are subjected to a series of tests following standards and regulatory requirements for capsule products. These are permeability and sealing, potency and impurity content, weight variation test depending on capsule type, content uniformity, dissolution test, moisture content, and permeability test.
Finally, these factors help identify whether the batch is acceptable for sale or for its intended use.
CapsCanada is up to date in quality
All processes implemented in during the manufacturing process are monitored at CapsCanada. Our company uses raw materials previously studied, not only during the distribution process but also during manufacturing. This guarantees the quality and good performance of the product.
CapsCanada is an ISO-certified company and all capsules are produced following current Good Manufacturing Practices. It has also adopted NSF/IPEC/ANSI 363-2016 GMP for excipients based on ISO 9001 principles to produce capsules for use in pharmaceutical products.
Regardless of their final use, all capsules are thoroughly checked during manufacturing to ensure that their color, weight, dimensions, and humidity remain consistent and within specifications.