GMP rules for maintenance

Hi, 

Any specific requirements like BRC? 

;)

I generally have top level program that describes what measures should be considered for maintenance and construction that take place.  Describe a need for controlling contamination, things like partition walls surrounding the area, notices for employees to keep out, QA tech to observe the process and ensure no cross traffic is permitted, etc., and then calling for proper sanitation to occur once the work is complete.  The program also calls out for each job to be written up with the work order or other supporting planning documents on how we will mitigate foreseen risks. 

Basically every job/project will usually have unique challenges you'll want to address, and it's up to you to document a plan on what needs to be done to mitigate them.  At the end of the job, document that sanitation was performed, whether any risks were present to product and whether it required any remediation.

If you're talking about larger projects like construction/rebuilding jfrey's post above covers it well. The action you'll need to take to uphold GMP are going to be pretty situational based on the project at hand. Better to do a thorough assessment for reach project rather than try to write rules that cover every conceivable thing. Also, these larger projects are (hopefully) rare enough that it won't be too burdensome to write something into the project scope every time.

For more common maintenance activities like equipment repair or upkeep, procedures typically state that the equipment must get a full cleaning and inspection after maintenance. Special care must be taken to ensure the site is free from tools or debris left behind by maintenance crews.

jfrey123, le 02 oct. 2023 - 6:12 PM, a dit:

J’ai généralement un programme de haut niveau qui décrit les mesures à envisager pour l’entretien et la construction qui ont lieu. Décrivez un besoin de contrôler la contamination, des choses comme les cloisons entourant la zone, les avis aux employés de rester à l’extérieur, le technicien d’assurance qualité pour observer le processus et s’assurer qu’aucune circulation transversale n’est autorisée, etc., puis demander que des mesures sanitaires appropriées soient effectuées une fois les travaux terminés. Le programme exige également que chaque emploi soit rédigé avec le bon de travail ou d’autres documents de planification à l’appui sur la façon dont nous atténuerons les risques prévus.

 

Fondamentalement, chaque travail / projet aura généralement des défis uniques que vous voudrez relever, et c’est à vous de documenter un plan sur ce qui doit être fait pour les atténuer. À la fin du travail, documentez que l’assainissement a été effectué, si des risques étaient présents pour le produit et s’il nécessitait des mesures correctives.

 

Hello,

 

Thank you for your answer

Could you please share with me some documents?

This is the first time for me and I have no idea how to manage this

 

Regards

 

 

Hello,

I think this list of document you should have to control GMP for maintenance activity

1. Personal hygiene for maintenance member

2. Special tools only used inside of the production area 

3. Make sure there is no cross traffic in your working area.

4. SOP maintenance activity

But , If you're talking about larger projects like construction/rebuilding jfrey's post above covers it well

and i think you should do this activity only when day-off (no production activity)

Thanks