¿Cuáles son los pasos para mantener un sistema de calidad GMP?

Maintaining a strong GMP quality system involves a comprehensive QMS, document control, regular training, structured change management, CAPA for deviations, risk management, monitoring key performance indicators, ensuring supplier compliance, internal audits, process/system validation, continuous improvement, data integrity, staying updated on regulations, and fostering effective communication. This ensures ongoing GMP compliance, quality, and safety in manufacturing processes.

I agree. In general, policies are the 'what'. These establish the stratigic state of compliance aligned with the regulations knowning that the 'how' is specified in detail in lower documents.

The Quality Policy is the simplest way to communicate your company commitment to Quality. Some important things to remember: 1) Ensure it is reviewed periodically to make sure it is up to date - update with goals you want to improve on! 2) Make sure it is visible to all - best location I’ve seen is on the back of company ID cards! 3) Keep it short, something everyone can remember. No more than a few lines, maximum!

Agree on the importance of defining a Quality Policy in clear and simple language; however, it is also important to make sure that all members of the organization understand it and understand their responsibility within.

Ensure to continuously improve on the facility's existing GMP Program so as to eliminate any lags in between the process to enhance effectiveness

It is important that SOPs and Work Instructions are written by or at least with input from the users and operators that perform the activities. When procedures are imposed on operations without their involvement in defining the procedure, they tend not to be followed. If the procedure doesn't reflect actual practice it is useless.

It is expedient to write down procedures to avoid omission and also to ensure compliance which the end result is good quality product.

Internal audits are an important aspect of quality assurance. They help a regulated company be confident that the quality controls built into operating procedures are working effectively. While it is important for the evaluations to be independent, it is important that operations understand internal audits are primarily part of the process to protect patient safety and product quality and not to find fault or blame. In that respect, Quality Assurance should be more partners than police.

In a manufacturing environment it is important to listen to the shop floor personnel…. The machine operators, the preventive maintenance personnel…. They are the ones more hands on and they know the exact problems …. They probably also have critical inputs to correct the issues which ultimately helps in revising your QMS during various reviews.

A robust regulation intelligence process will assure systematic and proactive input into your quality manuals with new and updated regulations that are essential to stay compliant.

It is important that the SOPs and Work Instructions continue to be effective and therefore they should be regularly reviewed and kept up-to-date. Each review is an opportunity to consider the purpose, to check if the activities are really required, and whether complexity could be removed. There is a tendency for SOPs and Work Instructions to grow over time. It is important that what is intended as improvement doesn't become counter-productive and make it harder for the user/operator to follow the instructions consistently. For example, responses to audits often result in updates to SOPs and Work Instructions. But it is important to consider whether the instructions could be improved by removing unnecessary detail, rather than adding more.

I would like to add. SOPs and Job Plans play the most important role here. Making sure they are created with the highest accuracy possible and always up to date, also regularly doing internal audits to make sure the staff complies with them. Lastly, the quality system efficiency has to be culturally impregnated in the staff, recognizing each and every one of the personnel that shows commitment in following the flow step by step, and doing it right from the first time. A "top of the line" quality system should be built by smart and realistic minds that understand human psychology.

Seeking external certification will open your eyes and your mind, fresh perspective from organizations that "have seen it all" will help you put your feet on the ground and start making the most effective changes to your GMP quality system. The brand of your industry will grow exponentially by making public the certification of an external audit from a prestigious organization. It will also prepare even more your personnel for future changes and innovations. Making your own staff proud to be certified and in compliance will make them feel even more bonded with their career and the company.

This aspect is key in GMP, Its helps to ascertain a genuine inspection has been conducted and it is helps to identify where there is lapses during the entire process so that correction and amendment can be made where necessary.

Continuous improvement is the key to staying in the game for years to come, we all know how many others have drifted away from compliance from time to time because they have stayed in their confort zone. Innovation, changes(revisions), challenges and a open mind will keep the organization on track for success and quality compliance. Finding ways to make processes more reliable and compliant is a task that needs to be done regularly. This is the primary reason why SOPs need to be regularly revised to ensure that processes remain effectively aligned with the quality policy.