What are the important thing to be considered for
Planned Power shut down for 2 weeks and power
What are the relevant documents to be maintained!!
Thank you Mr. Sajjad
well come bro
How about the Stability chamber? What actions need to be conducted when cut down the power?
The document shared by Mr. Sajjad is really important . I have read it before and it was very useful
The power supply to the Stability chamber should be supplied through generator or any other source.
Moreover, additional datalogger should be placed in-order to monitor the temp and RH conditions.
Dear Mr. Sajjad,
i have some queries,
- For phase-II Could you please provide the contents for Audit (plant review) and signoff checklist, i mean what should be the content of it–just for reference.
- Suppose unplanned changes conducted or done–maintenance work, during shutdown period how it can be covered? or handled through QMS.
- Is it required to wait for microbial results, before starting full production?
- which case equipment may require revalidation or verification check after resume.
In shut down if equipment and area having major break down should be on requalification.
Equipment having major changes of parts during maintenance should be revalidated.
It is better to conduct microbial testing after major maintenance work but some may relay on just non viable particle count which have many risks.