我们能提供的GMP咨询服务

2022-06-10 · 法默康

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由于GMP法规的描述是概括性、开放性的,有一定的解读空间,因此不可能逐条按照法规来实施GMP----。正因如此,许多客户会产生疑惑:哪些法规是相关的?哪些是强制性的,哪些是非强制性的?一项要求需要如何落实?要选用什么样的方法以及需要什么样的文件?法规涉及公司哪些部门,需要在何时审核什么内容?……但可以确定的是:无菌生产、化工和现代生物技术企业的GMP的要求各不相同。

Since the description of GMP regulations is general and open, and there is a certain interpretation space, it is impossible to implement GMP according to regulations one by one. Because of this, many customers will have doubts: which regulations are relevant? What is mandatory and what is not? How does a requirement need to be implemented? What method should be used and what documents are needed? Which departments of the company are involved in the regulations, and what content needs to be reviewed at what time However, it can be determined that the GMP requirements of aseptic production, chemical industry and modern biotechnology enterprises are different.

GMP咨询顾问可以针对性地解决这些疑惑。我们有丰富的实践经验,并且能将专业知识和实践经验相结合 。

GMP consultants can solve these doubts pertinently. We have rich practical experience and can combine professional knowledge with practical experience.

实现GMP符合性

Achieve GMP compliance

咨询项目旨在快速确保GMP符合性,否则质量保证缺陷不仅会对产品质量和消费者保护产生影响,还会使产品不能及时上市,造成巨大的经济损失。为此。不仅提供GMP实施经验,还提供审计和检查的陪同、准备以及跟进服务。深知客户确切需要什么,能帮助客户可靠地解读GMP要求。

The consulting project aims to quickly ensure the GMP compliance. Otherwise, the quality assurance defects will not only affect the product quality and consumer protection, but also make the products unable to be listed in time, causing huge economic losses. For this purpose. Not only provide GMP implementation experience, but also provide accompanying, preparation and follow-up services for audit and inspection. Knowing exactly what customers need can help customers interpret GMP requirements reliably.

注重解决方案的可行性——建立在实践基础上的咨询

Pay attention to the feasibility of the solution -- consultation based on practice

理论性的、脱离实践的解决方案终将因为缺乏可行性而不能实施。在项目中参与GMP解决方案的实施,因此客户可以确信所提出的解决方案和理念是实践导向的、务实可行的。

Theoretical and practical solutions will not be implemented because of lack of feasibility. Participate in the implementation of GMP solutions in the project, so customers can be sure that the proposed solutions and concepts are practice oriented, practical and feasible.

更好的解决方案,避免无效工作

Better solution to avoid invalid work

客户常常担心顾问会站在保险的角度建议进行尽可能多的工作,但与合作,您不必担心这个问题。我们重视解决方案的经济性。我们深知:除了符合性和可行性,经济效率也相当重要,尤其在大规模生产低成本产品时,这点尤为重要。

Customers often worry that the consultant will suggest as much work as possible from the perspective of insurance, but you don't have to worry about this problem if you cooperate with them. We value the economics of solutions. We know that in addition to compliance and feasibility, economic efficiency is also very important, especially in mass production of low-cost products.

根据对监管要求的深入理解,设计出可持续和的解决方案。在适当的时间提供正确的咨询

Design sustainable and solutions based on in-depth understanding of regulatory requirements. Provide the right consultation at the right time

为客户提供多种咨询方案,方案终取决于产品、工艺和现有项目产生的任务要求。

Provide customers with a variety of consulting solutions, which ultimately depend on the product, process and task requirements generated by existing projects.

我们提供以下基本咨询服务:

We provide the following basic consulting services:

基本GMP问题的合规性咨询

Compliance consultation on basic GMP issues

验证、文件或整合概念的GMP咨询

GMP consultation for validation, documentation or integration of concepts

具体问题的专业咨询,例如:检查相关问题

Professional consultation on specific issues, such as checking related issues

GMP执行过程中的持续符合性咨询支持您将获得:

Continuous compliance consultation support during GMP implementation you will receive:

GMP法规及其要求的概述和解读

Overview and interpretation of GMP regulations and requirements

针对具体要求、产品、工艺和项目量身定制、切实可行的咨询方案

Practical consulting solutions tailored to specific requirements, products, processes and projects

由具备深厚专业知识、法规知识和多年实践经验的专家提供的咨询服务基于经济效益的合作伙伴式咨询服务

Consulting services provided by experts with profound professional knowledge, regulatory knowledge and years of practical experience cooperative consulting services based on economic benefits

本文的精彩内容由GMP咨询公司提供知识提供,本网站还有很多的精彩内容,更多的内容您可以点击进入:https://www.fmkgmp.com我们有专门的客服为您解答问题

The wonderful contents of this article are provided by GMP consulting company. There are many wonderful contents on this website. You can click to enter more contents: https://www.fmkgmp.com We have special customer service to answer your questions