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Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, [1] uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation ...
The European Committee for Food Contact Materials and Articles (CD-P-MCA) [37] is tasked with developing and strengthening harmonised measures that supplement EU and national legislation to ensure the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported by two subordinate bodies: the ...
A raw material, also known as a feedstock, unprocessed material, or primary commodity, is a basic material that is used to produce goods, finished goods, energy, or intermediate materials that are feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck assets and are required to produce other products.
Process manufacturing is common [3] in the food, beverage, chemical, pharmaceutical, nutraceutical, consumer packaged goods, cannabis, and biotechnology industries. In process manufacturing, the relevant factors are ingredients, not parts; formulas, not bills of materials; and bulk materials rather than individual units.
Special food contact materials are used when the package is in direct contact with the food product. Depending on the packaging operation and the food, packaging machinery often needs specified daily wash-down and cleaning procedures. [56] Health risks of materials and chemicals that are used in food packaging need to be carefully controlled. [57]
The Standard typically applies to (a) components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up (b) systems that are a critical part of product manufacture [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage].
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
Food rotation is important to preserve freshness. When food is rotated, the food that has been in storage the longest is used first. As food is used, new food is added to the pantry to replace it; the essential rationale is to use the oldest food as soon as possible so that nothing is in storage too long and becomes unsafe to eat. Labelling ...