EU lab Co-ordination

EU Lab Name:

 DAU
 Eurofins
 Misom
 Pharmadox
 Meditrial

Forecast from SCM

Share the forecast to all our EU labs and get the analytical standards stock to
complete the batches.

We need to arrange the analytical standards (WS, Impurity, Placebo) based on the
request from labs.

 Aurobindo – All standards are arranged by supplier and no cost involved.

 Hetero - All standards are arranged by supplier and no cost involved. Only
Levocetirizine Impurities needs to be arranged Impurities from other approved
source (Chromachemie).
 Titan - All standards are arranged by supplier and no cost involved. We need to
arrange Impurities from other approved source (Chromachemie).
 Alembic – Working standard and placebo shall be arranged by supplier and no
cost involved. Only Impurities needs to be arranged from other approved source
(Chromachemie).
 Intas - All standards are arranged by supplier and no cost involved. Sometimes
we need to arrange Impurities from other approved source (Chromachemie).
 Medreich - All standards are arranged by supplier and no cost involved. Only
Naproxen WS and Lithium Clavulanate WS needs to be arranged by lab or from
other approved source (Chromachemie).
 Cadila - Working standard and placebo shall be arranged by supplier and no
cost involved. Only Impurities needs to be arranged by lab or from other
approved source (Chromachemie).
 Sharon - Working standard and placebo shall be arranged by supplier and no
cost involved. Only Impurities needs to be arranged by lab or from other
approved source (Chromachemie).
  Refer below path for Standards management Log.

I:\Batch Related\EU lab COA's\Lab materials\Analytical Standards management Log

Pre-Alert email.

 Enter the batch details in sequence to the batch release excel. Wait for the
mother batch details from BR team and finalize the micro testing frequency.
 Once all entries done, then prepare the sample order forms to lab and sampling
check list to DHL.
 Refer below path for batch release excel.

https://bluefishpharma.sharepoint.com/sites/qa/Shared%20Documents/Forms/
AllItems.aspx?id=%2Fsites%2Fqa%2FShared%20Documents%2FQA%2DM%20
and%20S%20Documents%2FQA%20Stockholm&viewid=ebba01f3%2Df876%2
D4300%2D95c4%2De363f5cb0481

 Refer below path for sampling check list and sample order form.

I:\Batch Related\Batch Related Documentation\Ordering of sample analysis 2014-04-

30\Sampling and data logger checklist DHL

I:\Batch Related\Batch Related Documentation\Ordering of sample analysis 2014-04-

30\Sample ordering QC-lab

 Refer below path for if any additional sampling requests.

I:\Batch Related\Batch Related Documentation\Additional sampling request

 Track with DHL until the sampling done. Share the tracking details to relevant EU
lab and get it acknowledged the receipt.
 Refer below path to archive the datalogger reports from EU lab samples .
I:\Batch Related\Batch Related Documentation\Data logger reports 2014-04-30-\EU
Lab Data Loggers

 Track the analysis at lab until CoA receipt.

Regulatory request

 Acknowledge and review the received regulatory request. Discuss internally and
finalize the actions. Follow up and complete the relevant actions.
 Refer below path for Regulatory request tracker.

I:\Batch Related\EU lab COA's\Regulatory request

Invoices
 EU labs shall share the Invoices after CoA/BRC is completed.
 Refer below path for Invoices. Archive the received Invoices and enter the
number on batch release excel.

I:\Batch Related\EU lab COA's\Invoice for EU testing

 Refer below path for service agreements.

I:\Quality System\Quality (Technical) Agreement\Supply - Commertial TA - QC

Laboratories\Active Labs

 Review the Invoices against the sample order forms and batch release excel. If
everything is clear , then create the PO in NAV.

Monthly report

 Review and update the monthly reports.

 Refer below path.

I:\QA Monthly Reports\2024

Digitally signed by Antrol Reji

DN: cn=Antrol Reji, o=Bluefish
Pharmaceuticals Pvt Ltd,
ou=Asst. Manager - QA,
email=antrol.reji@bluefishphar
ma.com, c=IN
Date: 2024.04.17 09:19:38
+05'30'