皮肤损伤的治疗最近取得了巨大进步。这种治疗包括同种异体和异种移植和皮肤替代品,如组织工程皮肤,培养细胞,和干细胞。本文的目的是讨论在细胞和组织产品制造中实施的质量保证和质量控制的一般概述,强调我们在MyDerm®制造方面的经验,一种自体双层的人类皮肤替代品。制造MyDerm®需要多个高风险的开放式操作步骤,如组织处理,细胞培养扩增,和皮肤结构形成。为确保本产品的安全性和有效性,良好生产规范(GMP)设施应建立精心设计的质量保证和质量控制(QA/QC)计划。应实施标准操作程序(SOP),以确保制造过程一致并以受控方式执行。所有起始材料,包括组织样本,文化媒介,试剂、和消耗品必须经过验证和测试,以确认其安全性,效力,效力和不育。最终产品还应进行QC测试系列,以确保产品安全,功效,和整体质量。洁净室操作员的无菌技术和设施的环境条件也很重要,因为它们直接影响优质产品的制造。因此,人员培训和环境监测对于保持GMP合规性是必要的。此外,风险管理实施是质量保证/质量控制的另一个重要方面,用于识别和确定风险水平,并在必要时进行风险评估。此外,应建立不符合项报告程序,以识别,调查,并纠正制造过程中出现的偏差。本文提供了组织工程和再生医学中心符合GMP要求的MyDerm®生产过程中QA/QC方面的见解和概述。医学院,马来西亚Kebangsaan大学。
Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting materials, including tissue samples, culture media, reagents, and consumables must be verified and tested to confirm their safety, potency, and sterility. The final products should also undergo a QC testing series to guarantee product safety, efficacy, and overall quality. The aseptic techniques of
cleanroom operators and the environmental conditions of the facility are also important, as they directly influence the manufacturing of good-quality products. Hence, personnel training and environmental monitoring are necessary to maintain GMP compliance. Furthermore, risk management implementation is another important aspect of QA/QC, as it is used to identify and determine the risk level and to perform risk assessments when necessary. Moreover, procedures for non-conformance reporting should be established to identify, investigate, and correct deviations that occur during manufacturing. This paper provides insight and an overview of the QA/QC aspect during MyDerm® manufacturing in a GMP-compliant facility in the Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia.