GMP, the Chinese meaning is "production quality management practices" or "good practices," "good manufacturing standards." In a nutshell, GMP requires manufacturers of pharmaceuticals and foodstuffs to have good production facilities, reasonable production processes, sound quality management and strict testing systems to ensure that the quality of the final product, including food safety and hygiene, meets regulatory requirements.
Many pharmaceutical companies increasingly feel the difficulty of the new version of GMP certification. Among them, a considerable number of small and medium-sized pharmaceutical companies have fewer production lines and lack of risk prediction on the change of laws and regulations. There is no institutional regulation on their plant design and regular renovation and upgrading, which necessitates long-term transformation tasks before the new GMP deadline. However, discontinued production faces the threat of losing market without stopping production.
First, the verification activities in the role of pharmaceutical engineering
● To ensure the integrity of the pharmaceutical engineering quality derivation process
Since verification is the process of derivation of quality, then in order to ensure the integrity of the derivation process, verifying the professional participation in the whole process of the project is an inevitable choice. This is a qualitative requirement.
This is also true. Since 2010, many foreign-funded enterprises have clearly pointed out that when looking for a construction contractor, they need to verify the full participation of experts. It is interesting to note that more than 50% of these inquiry companies are not pharmaceutical projects or even life science projects. According to the pharmaceutical industry, these projects are not validated.
Systematic to ensure the smooth progress of pharmaceutical engineering
As a process of deriving quality, verification is done through a series of activities to ensure its effectiveness. This is a quantitative requirement.
As a result, many companies request engineering contractors to present verification management systems and successful project cases after they have been asked for verification. Verify execution has become an indicator to judge the project contractor's ability.
● Pharmaceutical engineering and end-user compliance an important part of convergence
Validation is a proactive activity for the project itself; for a pharmaceutical project, not only to meet the validation needs of the project itself, but also to validate the requirements described in the pharmaceutical industry regulations. In other words, at this stage, the contents of the validation of pharmaceutical engineering may be more stringent.
Now we can understand that: If the project management company and you talk about verification, it does not necessarily mean that the GMP verification; GMP consulting firm and you to verify that it must not be verified in the engineering sense; only focus on Pharmaceutical engineering project management company and you talk about the verification, it may be that we are concerned about the validation of the pharmaceutical engineering. Unfortunately, after experiencing the industry turmoil in 2011-2013, no engineering management company focused on pharmaceutical engineering validation exists in China.
Second, verify the management system and quality management system
● Verify the relationship between the management system and the quality management system
For the engineering management company, the quality management system is the company's ISO system, there must be; verification management system is a separate set of working documents, not necessarily an integral part of the quality management system.
● project verification management system and project quality management system
Project quality management system and project verification management system are developed by engineering contractors and pharmaceutical companies and act on the designated project management system. Both can be part of a project's implementation plan.
● project verification management system
For the pharmaceutical project, the project verification management system not only meets the requirements of project verification, but also meets the GMP requirements of pharmaceutical companies for all phases of pharmaceutical engineering. There are two elements here, one based on the project itself and the other based on a specific target industry.
Therefore, in the construction of pharmaceutical engineering verification management system, we should pay attention to include the following aspects:
➤ Engineering Industry Verification Requirements.
➤ Validation Requirements for Pharmaceutical Industry.
➤ Verification Requirements for Device Vendors.
It is important to point out that the construction of the project verification management system is the result of discussions among various stakeholders in the project. Here we must pay attention to identify a misunderstanding: equipment suppliers or contractors to provide a one-sided verification management system is limited and can not be directly used as a verification project management system for the use of pharmaceutical engineering.
Verification is a quality-derived activity. Equipment suppliers also have to do their own quality to derive their own activities. In other words, device vendor verification is not a true subset of pharmaceutical engineering validation.
Strictly speaking, the verification of equipment suppliers also covers the complete life cycle of their products. In this sense, the supplier verification required by our pharmaceutical engineering verification should be the intersection of complete supplier verification and verification of pharmaceutical engineering!
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