Endo pharma vp compliance quality12/29/2023 You might not be able to cite all the regulations, but an awareness of the GxP or regulatory requirements applicable to your job is necessary. Not all of us hold a role in Quality or Compliance, but we are all contributing to quality and compliance. Hence we always say: Quality beyond Compliance – if we aim to achieve product quality, compliance comes naturally. They often lay down the minimum requirements in order to achieve product quality, and without implementing those measures you can barely achieve product quality consistently. The regulatory requirements are established for the whole industry with various technology and experience levels. While the terms ‘quality’ and ‘compliance’ are sometimes used interchangeably, there’s a significant difference. When medicine manufacturers establish and execute their policies and procedures in accordance with those regulatory requirements, guidance and consensus standards, they are in compliance. ISO), have been developing requirements, guidance and standards to regulate and guide the industry, hence, to safeguard the patients. To achieve the above, health authorities, together with professional organisations (e.g. Safety is to ensure any potential risks like carcinogenicity, genotoxicity and reprotoxicity are uncovered and well understood.Įfficacy provides the patients with the right strength of medicine to be effective, yet not toxic. The quality of medicines is achieved through controls defined in GxPs and more. physical, chemical and microbiological specifications) throughout the whole shelf life. Quality focuses on medicinal products meeting the pre-defined specifications (e.g. However, regardless of the complexity of technologies and regulations, there’s only one ultimate target for everyone – to assure patient safety by delivering medicine with the required quality, safety and efficacy.
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