Manufacturing Formulae, Processing and Packaging Instructions (EU terminology), or Master Production and Control Records (US terminology) are documents that provide detailed batch size requirements and manufacturing instructions for products. These documents define how the product is produced, indicating specific types and quantities of components and raw materials used, processing parameters, in-process quality controls, environmental controls, yield requirements, storage requirements and packaging requirements.
PSC Biotech’s highly experienced staff can help you review your Master Production and Control Records and provide advice on how to ensure that this essential document passes regulatory scrutiny. Where required, we can produce new documents or revise your existing ones.
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