Dear Mahesh Garu,

Find the comments for Pluto Stage 2 Low Yields

1. Using Fresh IPA or Recovery IPA , absolutely there is No impact on Yield loss
 Fresh IPA Used for 10 Batches & Average Yield         : 312 Kg (0.58) =    Old Process for PLU- 3
 Recovery IPA used for 3 Batches & Average Yield   : 326 Kg (0.62) =    Old Process for PLU- 3
 Recovery IPA used for 4 Batches & Average Yield   : 242 Kg (0.44) =    Old Process for PLU- 3
 Fresh IPA Used for 10 Batches and Average Yield    : 362 Kg (0.66) =    New process for Sun pharma Dispatch
Note : From the above by using recovery solvent , Yield is more compared to fresh IPA Usage (326 Kg/0.62)
Hence using recovery solvent is ruled out for Yiled loss 
Important Point Is Even with IPA slurry purification also, More Yiled obtained in Sun pharma route (362
Kg) , Existing process is capable to produce 312 Kg only )

             

PLU-2 Batch Details = Fresh IPA Used

S.No Batch No Input OutPut Yiled Remarks IPA
1 APLU-II 21009 525 363 0.69 IPA fresh
2 APLU-II 21010 531 273 0.51 Low Yiled IPA fresh
3 APLU-II 21011 526 368 0.70 IPA fresh
4 APLU-II 21012 527 359 0.68 IPA fresh
5 APLU-II 21013 542 258 0.48 Low yield IPA fresh
2. Batch No # 023 & 024 - Reaction monitoring TLC
6 APLU-II 21014 541 254 0.47 Low yield IPA fresh
7 APLU-II 21015 540 325 0.60 IPA fresh
not Passed till 5 samples , suddenly 6th Sample TLC
8 APLU-II 21016 541 340 0.63 IPA fresh passed.
9 APLU-II 21017 541 317 0.59 IPA fresh Brief process :
10 APLU-II 21018 551 264 0.48 Low Yiled IPA fresh
Average Yiled : 312 Kg (0.58) : IPA Fresh Used
PLU-I - 530 Kg , MDC- 2650 L, DMAP -
34.55 Kg at 0-5°C, slowly add TEA - 318
Kg /Clear SOL
Slowly add R104 - 275.6 Kg, 2Hrs – Stirring, TLC check - PLU-I Limit : NMT - 5%,
If Fails: Charge R104 -27.50 Kg, 2 Hrs. Stirring, TLC Check till complies, Extract with MDC

.        

 After 2 hrs maintenance, TLC checked 5 times & not passed (PLU-1 in PLU-2 : NMT-5%)
But during 6th Sample, TLC passed (PLU-1< 5%)
 As per QCD chemist in 6th sample PLU-1 spot not detected against 5% PLU-1 std in TLC plate,
He Surprised how the big spot PLU-1 disappeared immediately in 6th hr. sample.
for confirmation purpose, He tested twice and found same result. 
 As per His observation , all 5 samples have bigger PLU-1 Spots than 5% PLU-1 spot in TLC plate
Suddenly In 6th sample PLU-1 Spot disappeared, usually it will not happen until & Unless if Reaction
mass sample changed. 
  That means 6th sample TLC tested with approved sample. It was clearly managed in QCD for 23 & 24
Batches by Production team
results unreacted PLU-1 carry forwarded in PLU-2 stage
 Due to Unreacted PLU-1 (5.6 % & 3.4 %) in PLU-2 stage, Low yield obtained In Batch No 23 & 24

Finally, water washing to MDC layer

 water washing is providing to MDC layer to remove unreactant PLU- 1 < 5% , but 5.6 % & 3.4%
PLU-1 reported in 2 Batches even after water washings
Confidently we can be able to confirm that TLC manipulation is done 1st reaction itself.
 Further Personally I discussed TLC issue to Mahesh Aitha Garu & Sahadeva Reddy Garu too, but
they Ignored this point
And Investigation concluded without proper Justification.
 Moreover, this is well established process , 32 Batches Executed, but even though TLC was managed
in QCD ,  
And Without Taking any explanation by Block In charge and Shift In charges, What Explanation is
expecting from me by Lakshmipathi ,
I do not understand How I must take responsibility if somebody did mistakes and not even discussed
anything to me

3. Root cause: The higher PLU-01 content is identified (Batch No: 23 and 25) due to usage of same AOD pump
for both TEA and R-104 addition, which yield the neutralization of TEA and resulted lower yield.
Additionally, the water calculation from Rec.IPA was not considered by chemist and mistakenly total 2.4
volumes of water was charged and proceeded for reaction which resulted higher URD-1 content which further
resulted lower yield.

The Higher PLU-01 content is Identified due to AOD pump using for TEA and R-104 Addition,
which yield the neutralization of TEA and resulted lower yield
 As per process TEA - 318 Kg & R104 - 275.6 Kg, Point is can anybody neutralize these huge
quantities by Using AOD pump
 I do not think So , the hold Up Quantity in AOD may be 2 Lts only , this small quantity may not
impact to neutralize TEA & R104
 Further TEA and R104 is directly mixing in the Reactor, we cannot avoid neutralization process in the
reactor vessel    
 This is also stating Improper investigation and the same is accepted by Our senior team also

Additionally, the water calculation from Rec.IPA was not considered by chemist & mistakenly
total 2.4 volumes of water was charged and proceeded for reaction
 First 3 Batches was executed by Chemists with recovery IPA and Found good yields.
 Further 4 Batches , Chemist Mistakenly charged 2.4 vol of water with Recovery IPA and found lower
yield.
 Surprisingly all the 7 batches were executed by same chemists. But Initial 3 batches chemist did not
do any mistake further 4 Batches Mistakenly all four chemists added 2.4 Vol water , Can any Body
expect what went wrong and who influenced them. No We do not have enough answers
 Just to save some one, simply the Issue diverted on to Chemists and We report as Mistakenly Chemist
did mistake
 
which resulted higher URD-1 content which further resulted lower yield

 
                      
                            
                             Assuming that if the above statement is ok ,can we Justify the Following points
                             1st case
 In batch No # 002 – 355 Kg obtained ,  URD-1 (PLU-III) content in Rxn-2 is – 8.88%
 In batch No # 024 – 260 Kg obtained ,  URD-1 (PLU-III) content in Rxn-2 is – 8.77%
                       
Even URD-1 result is same, we lost 95 Kg yield, surprisingly in 2 nd batch 2.4 Vol water not added, but
URD-1 is same in both batches.

2nd Case:
 In batch No # 022 – 309 Kg obtained ,  URD-1 (PLU-III) content in Rxn-2 is – 11.7 %
 In batch No # 024 – 260 Kg obtained ,  URD-1 (PLU-III) content in Rxn-2 is – 8.77%

                        In 2nd Batch the chemist mistakenly did not added 2.4 Vol water, But URD-1 content is increased to
11.7% o how it is possible without adding 2.4 Vol water , The URD-1 is increasing.
                       
Concluding that the above statement cannot be justified, So TLC managing is the main Culprit
for yield loss.

Conclusion :
 In Batch No # 023 Actual - 150 Kg only obtained , but reported as -190 Kg by mixing with
old material ,
And almost 200 Kg Material loss obtained in this Batch.yield loss for this is batch is mainly
due to 6th sample
managed in QCD in TLC checking. PLU-1 - 5.6 % unreacted
 In # 024 also lower yield Obtained and this batch is also reported as 260 Kg (Material
adjusted from # 25 Batch )
yield loss obtained mainly due to Unreacted PLU-1-3.6 % in 1st TLC
 For 025 & 026 Batches Low Yiled is due to this batches Material adjusted for the batches 23
& 24
The average Yield for the Four batches are - 238 Kg instead of 330 Kg , almost 350 Kg Loss
Obtained

Dear Mahesh Garu, Just I want to bring to your notice that how the actual things manging in
different way in ALS from top to bottom

 PLU-1 content in PLU-1 - 6th Sample TLC is well managed in QCD

 TLC issue is not yet addressed in Investigation.
 We tried to Blame on AOD pump usage , which is not culprit as I said above
 In 23 & 24 Batches actual yields not reported by Shift In-charge & Block Manager to
me and to any anybody including you.
 If Higher side yield noticed in any batch, Part quantity Removing and mixing the
same quantity into Low yield observed batches.
(Material Mixing, Exact Quantity not declaring & keeping some quantity side and
mixing in low yield batches)
 Proper Investigation is not conducting by CFT , and Route cause is not establishing,
But Miss leading the Top management  
Simply we just protecting some employee’s interest. Example Chemists Mistakenly
Did Mistake, But Block In charge & Shift In-charges all are escaped from
Investigation . But even scientifically it was wrong as above     
 Koteswarao had not given any communication about yield loss, You know that very
well as per QAD conference hall conversation
 You directed him that further any yield loss , communicate immediately which is not
happening regularly by Koteshwarao
 Some employees Knowingly or unknowingly committing Mistakes , surprisingly they
were well protected by our senior team
Example in the above case, huge material loss Obtained but Block manager or shift
in-charge is not offered any show cause 
and they were not come under investigation scope  
 In PLU-2 - IPA - 4500 L to be used for sun pharma batches, but 3000 L only Indented
and the same consumed for 6 batches .
Remaining quantity – 1500 L not indented even after 10 Days, after 6 batches they
came to know that 1500 L indent missing ,
But Production Team & LP Garu well managed the documents, but no-Show cause
letter issued to anybody 
 Without PLU-1 approval , PLU-2 batch started, But PLU-1 is Under OOS
investigation as Lab error in HPLC
this is also well managed by LP Garu & Srinivas Reddy, fully quality Violation but
No action and show cause

 Everybody is thinking that Y. Srinivasaro is the only culprit for all these incidents,
with jet speed Show cause letter offered from Lakshmipathi . I never ever faced this
type of situations . Till date honestly, I discharged my duties at ALS
 I really Disappointed about this incident under your administration. If I am failing
means the entire ALS TEAM is also failing.
 Y. Srinivasaro alone cannot do anything
 All the ALS team must work as team, but here I found many teams working for their
self-interest and or some other. Requesting all give big hand to new Employees

Anyhow I resigned and relieving, but my sincere request is do not focus on