Pyrogen testing is important in the pharmaceutical industry because it detects the presence of pyrogens, which are substances that can cause fever. Pyrogens can contaminate pharmaceutical products during the manufacturing process and can cause serious health problems if they enter the body. Pyrogen testing helps to ensure the safety and quality of pharmaceutical…
Latest fatal incidents with contaminated medicinal syrup during 2022/2023. The presence of numerous cases that have caused several hundred deaths due to the use of excipients of inappropriate quality in pharmaceutical formulations continues to be a global concern. Some new cases of contaminated medicinal syrups occurred during 2022 and 2023 resulting in more…
Statistical Process Control (SPC) metrics like Cp and Cpk are crucial for assessing and maintaining the quality of manufacturing processes. Cp (Process Capability) measures the potential capability of a process to produce output within specified limits, indicating how well the process can meet specifications when it is centered. Cpk (Process Capability Index) considers…
Companies selling medical devices or pharmaceuticals are required by applicable regulations and standards to monitor the quality of the raw materials, components, and services that go into their products. For this reason, it is crucial that manufacturers have systems in place to ensure that purchases meet acceptable quality requirements. One essential and prevailing tool…
Supplier qualification is a process in which the organization assesses its suppliers regarding their licenses, authorizations, and compliance with regulatory requirements for the distribution of drug products. The organization should establish a written procedure for how suppliers are selected and evaluated, including the criteria for qualification and the period for requalification on a risk-based approach….
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety…
Supply chain planning has become a priority for most of the pharmaceutical companies. However, it is difficult to map which capabilities are required to solve specific supply chain planning challenges. There are many reasons for such difficulties, including but not limited to long lead times, capacity constraints, various operating models, multiple regulatory requirements etc….
Pharmaceutical supply chain is a crucial department in pharmaceutical industry. This department is responsible for smooth supply of materials. The major responsibilities of a supply chain professional mentioned below – Read also:
