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:
Supplier qualification is a critical process for pharmaceutical companies to ensure the quality and reliability of the materials, components, and services provided by their suppliers. Here are some key steps and considerations for approaching supplier qualification: 1. Define Supplier Requirements: Start by clearly defining the specific requirements for suppliers based on the type of…
Samples are retained to fulfil two purposes; Reference sample A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages or intermediates,…
