How can you use GMP quality audit results to improve your manufacturing processes?

1. ensure that all processes within your organization are running effectively according gmp std to the way they were designed. 2. you can identify sop /methods gap assessment processes and take immediate action to respective mfg areas for improvement. 3. The mfg related all gmp documents that are available ready before the actual audit the better because these can be evaluated without compromising the on-site audit time and process flow. 4. Ensure that your staff has the necessary training and preparation & ready for the audit.

These audits will give you a great insight about areas of improvement in your facility and you can chart down detailed corrective actions about observed non conformance. Must focus on highlighted issues along with other areas which could lead to potential risk. Trend analysis over months for such audits will give you good insight about required resources, investment on human resource and infrastructure to strengthen the system

We have experienced from GMP audits that outsourced inputs often contribute to the non-compliance which has silently crept in. When relying on outsourced inputs, maintaining control over the quality and consistency becomes crucial. The outsourcing process introduces additional variables and potential risks that can impact the final product. Effective control measures should be in place to ensure that the quality and characteristics of outsourced materials or services align with the established standards and requirements. GMP audits have surely helped us in the identification of such changes.

The statement looking good. I also agree to get a great plan before initiation the steps. So first prepare an out line with deep understanding. Than start conversation with skilled stakeholders.

Os resultados obtidos na auditoria servem para mostrar onde melhor dentro do nosso processo de produ??o, é através dele que teremos um processo mas detalhado.

See root cause analyses can be done different ways. Before starting Root cause analyses, find the right method. That can save time and Money. As well as will show the propre way to resolve the issue. So again, it needs experts people with enough experience. Experience people know the success and failure. They can see probable future from their experience.

The leader of the correction action for nonconformity team should’ve set team members from different backgrounds and expertise to perform different methods of root cause analysis when one method usually doesn’t work.

After the GMP quality audit results, first you have to identify the critical observations identified by the auditors and initiate a thorough investigation to determine the root causes of those observations and implement an effective CAPA. Then for the minor observations, you can determine their root causes too and provide hands on training and evaluation to personnel.

It is elementary to conduct a thorough root cause investigation for every non conformance. For a NC of manufacturing, its helps to reflect Quality culture of the organization and to keep QMS documents audit ready in case of any future complaints associated with the Batch/ lot in question. Root cause analysis can also identify lacuna, if any and thereby fill into the gap associated with the NC. Assessment of these Gaps can further strengthen QMS.

This step is the most important to get right. If you can't identify the true root cause of the nonconforming problem then the remaining steps are a waste of resources. Take the time to talk to the employees doing the work and people in different departments to get the full picture. There is typically more than one singular thing that causes nonconformaties.

Recordar que el enfoque principal de las GMP es la prevención y mejora del proceso así que no debemos centrarnos en la magnitud del problema, si no en la extensión de la posible respuesta buscando conseguir la estructura ideal del proceso o servicio. Que genere la productividad desea qué busca la auditoria. Recordando qué la meta< cerrar la no conformidad> no es el camino total, si no un puente para la obtención de un proceso más controlado.

As ACP, s?o importantes pois nos permite prevenir as próximas actividades, e também nos permite corrigir oque está mal através desse plano da ac??o corretiva conseguimos precaver muitos problemas que nas próximas Auditorias ser?o minimizadas.

Así que se debe recordar que cada acción sea correctiva o preventiva debe estar provista de una planeación, ejecución, verificación y ajuste , complementantando un seguimiento, implantación, control , normalizado, y eliminación de la desviación. A través de estándares medibles, comparables, repetibles,reproducibles, qué validarán la efectividad de dicha acción.

Toda Auditoria depois de gerar os resultados, ele passa numa processo de monitoriza??o, oque tem haver com acompanhamento de tudo que foi auditado e se na verdade está se cumprir com rugosidade.

Así que es importante recordar que las GMP son estándares qué han demostrado su fiabilidad y competitividad, buscando eliminar el error a través de la comprensión de las diversas fuentes de variabilidad.

Depois de gerar resultados através dos relatórios, é importante padronizar de formas que todos colaboradores tenham uma vis?o sobre actividade a executar, fazendo isso, estaremos em condi??es de amenizar as n?o conformidades.

Use the results of GMPs audits as input to the food safety culture process within the company: the method is simple (choose points from the audit , considered important in the company's GMPs and ensure their resolution by considering them as important points in food safety culture of the company Therefore the results will be achieved with great involvement of the workers........and will be sustainable

A prática è compartilhamento de métodos, processos e padr?es deve vir amparada por bons registros. Documentar, organizar e reter informa??es e documentos é a chave para garantir que a padroniza??o fa?a parte da cultura.

Perform root cause analysis of deficiencies reported in quality audits. Identify causes that are systemic in nature or indicates weakness in process robustness. Example- Sometime auditors are great at catching up some trends that are not highlighted during regular review as they could be well within limits. Go back to process validations/process performance data and challenge yourselves in view of new findings. Example I encountered was about high number of reprocessing batches produced by one Mfg site that I audited few years ago. They tried to defend by saying reprocessing is validated and filed. But high number didn’t go well with us and we issued an observation to have relook into process robustness.

Understanding that a quality audit is exactly that, an opportunity to improve procedures. Getting out of the mindset that quality audits are a test with a pass / fail outcome, will help to take the next steps in correcting any findings. Always assume that findings are systematic in nature, and begin a root cause analysis with that assumption.

GMP Audit purpose to get objective evidence of implementation of all requirements. Output of the audit to have the conclusion of the status of compliance against requirements e.g fully compliance or partially compliance or if there is a gap or area for improvement to work on it. So if there is any nonconformity or area of improvement then going through an action plan to achieve it is a cycle of Continuous improvement.

Depending on Continuous Improvement “KAIZEN” for improving the manufacturing processes and saving cost and improving the productivity and morality also continuous improvement principle will improve the quality of the product and the process itself, in some advanced industries we also can use some additional advanced techniques to improve the processes and reduce the defects which will cause of decreasing the scrap rate.

Root cause Analysis is a good technique to protect the Quality. I always consider practicing using this technique for minor quality issues while others prefer to not spend time on Minor Quality issues. In my opinion, the benefits are: a) Major and Minor Quality issues usually have the same root cause. By spending time to mitigate the reason for the minor issue we prevent future Major issues from occurring, so we are saving money. b) It is good training for your team to work and understand the procedure so that when the Major issues happen, your team is ready c) we implement a culture of Quality in the company.