Compliance Verification in

Microbiology Laboratory-
March 2021

Prepared By
Robit Siddiki
Executive QA

08/28/2021 1

Robit Siddiki Tirupati Lifesciences pvt. ltd.

Key Focus Points
 Good Documentation practices.
 Best Microbiological practices.
 Good Laboratory Practices.
 Good Review Practices.
 Analytical practices.
 Environmental Monitoring program.
 Validation/Qualification and Hold time study.
Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 2
Good Documentation practices.
 Some of dehydrated Culture media kept in accessories door for daily use
purpose w/o proper labelling i.e. :-
I. Frasser Broth base:- 0000421344 media opened on 11/02/2021 for
qualified its GPT but till date checked by sign not done in status label
affix on it.
II. EE Broth mossel :- 0000395413 Media opened on 22/02/2021 for qualified
its GPT but till date checked by sign not done in status label affix on it.
III. Muller hilton agar:- 0000390495 Valid upto 01/07/2020, Sabouraud
dextrose agar:- 0000380925 valid upto :- 23/04/2020, Nutrient agar:-
0000357976 valid upto :- 25/06/2020, Simmon citrate agar :- 0000357976
valid upto:- 29/01/2020. As per the status label media not used for
further analysis but till date 09/03/2021 kept in door.
Continued……

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 3

 media consumption record of FBB TLS/QCM/003/F/02-01 Lot No:- 0000421344/01/10,
entry closed for page no. 305 on dated 08/03/2021 but till dated checked by sign not
done.
 19-Media plate reconciliation record for TSA (RODAC PLATES) used for PM on 01/03/2021
but till date 10/03/2021 checked by sign not done.
 Good Documentation practices SOP TRP/CQA/O/010-001 not followed during filling of
document ( i.e. more than two remarks are written in usages log book of Dual
chamber lower TLS/QCM/044/F/04-00 & Usages log book of Balance TLS/QCM/WB-03)
 Usages log book of incubator TLS/QCM/028/F/02-01 (TLS/QCM/BI-05) used for keeping
47 MLT pathogen tubes of MCB on dated 05/03/2021 at 17:35 and 43 MLT pathogen tubes
of MCB on dated 06/03/2021 at 16:59 but from 09/03/2021 to till date records not
updated.
 Usages log book of incubator TLS/QCM/028/F/02-01 (TLS/QCM/BI-03) used for keeping
SCDM for EEB bottle on dated 11/03/2021 at 10:38 hrs. but from this date to till date
record not updated while test completed on 14/03/2021.

Continued......

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 4

 09 No's of Primary packaging material sampled on 08/03/2021 and analyzed
on 11/03/2021, in which 03 TDS found incomplete i.e. date of sampling,
sampled by, Date of Analysis, sample quantity and media detailed not
completed as on till date 16/03/2021.
 Usages log book of dual chamber (Lower) TLS/QCM/044/F/04-00, 12 plates of
BGBA (MLT) incubated on 12/03/2021 at 17:40 incubated completed on
14/03/2021 but till date record not update.
 Double door Autoclave thermal graph of dated 15/03/2021 kept in folder w/o
signing off.
 Destruction of used media/Vials culture and other accessories
TLS/QCM/026/F/01-01, Page No;- 507 strike out by NA without provided any
justification.
 Daily Verification record of balance TLS/QCM/036/F/01-01 reviewed by
pending from 11/03/2021 to till date.
 Miscellaneous sample entry register TLS/QCD/015/F/08-00 incomplete from
28/01/2021 to till date i.e. Remark's, Received by, Given By, not filled
properly.
Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 5
Continued…
 UV light burning hour record maintain for Pass box TLS/QCM/PB-01 as on
routine basic even though UV light not in working condition.
 During review of Raw material inward register TLS/QCM/013/F/07-00, its
observed that incomplete sample status has been made in inward register
while sample has been analyzed and released 03/02/2021 and 09/02/2021
respectively.
E.g.1:- Isomaltose:- 430360, 430361 and Maltodexterin:- 430756, 430757. and
A.R . No. not generated yet.
E.g.2:- Vitamin B12:- 400600903 analysis on 06/02/2021 but till date 27/03/2021
released by/results and status pending.
 Specimen signature not match with documented signature of Mrs. Rinky. i.e.
Usages log book of LAF-01 TLS/QCD/014/F/01-00 signature not verified.
 Daily Calibration record of pH meter TLS/QCM/062/F/03-00 loose format kept
in door and from 25/02/2021 format not used neither entry closed, if binding
log book has been in placed.
Continued…
Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 6
 Cleaning record of Autoclave TLS/QCM/039/F/01-00 entry not completed i.e.
cleaned by/Checked by sign pending on dated 27/02/2021 and from
20/03/2021 to till date document not used whereas frequency is weekly.

 Total Non conformance :- 17

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 7

Best Microbiological Practices.
 pH Meter used for routine analysis having not any
calibration status label.
 10 ml micropipettes not available laboratory for routine
analysis of MLT.
 Time not synchronized for all incubators.
 Media approval and qualification procedure not
incorporate in SOP of Media Management.
 Excessive no. of oxygen bubble formed in water sample during
sampling

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 8

 Media pour in analyzed plates of MLT & Water without checked its
temperature via I.R Gun. (Deviation of SOP)
 Purified water sample PW-59 fail in pH test parameter against the limit 5.50
to 7.50
 Water sample analyzed on 05/03/2021 and released om 10/03/2021 in which
some sampling point PW-05, PW-06, PW-47, PW-59, PW-31 having TNTC and
PW-30 having 1000 cfu & PW-17 having 180 cfu .
 Incubator door open for once 35 to 45 min and second 15-25 min for cleaning
purpose of floated sample of prohance mom. That lead to destruction of
incubation time of samples incubated inside incubator TLS/QCM/BI-04

 Total Non conformance :- 09

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 9

Good Laboratory Practices
 Calibration status label not affix upon pressure gauge installed with Vertical
autoclave TLS/QCM/AT-02
 Many of the 70 % IPA spray bottle used for routine purpose without proper
labeling i.e. Date of Preparation and Use before date not legible.
 UV light burning hour record maintain for Pass box TLS/QCM/PB-01 as on
routine basic even though UV light not in working condition.
 GLP practices not followed during analysis i.e. LAF bench not clean frequently
during performing MLT.
 Two colony counter installed in microbiology laboratory for observing plates
count but both are not in working properly i.e.
(1) TLS/QCM/CC-01- beep continuously while working on it meanwhile base light
not emit properly for its correctness as required
(2) TLS/QCM/CC-02 - counting marker not available during operation is going on.
Robit Siddiki Tirupati Lifesciences pvt. ltd. Continued…
08/28/2021 10
 Weighing balance TLS/QCM/WB-02 observed is in off condition once operation
has been done. And also used for further purpose w/o verification done.

 Total Non conformance :- 06

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Good Review Practices.
 In MLT TDS Analyzed By Sign pending on confirmation test of S.aureus whereas
checked by sign and reviewed by sign done (Product Name:- Formula 1
Nutritional Shake Mix Batch No:- E81468G19)
 Wrong Batch No. mention in TDS sheet i.e. B4KOO001 instead of B4KOU001
(Product Name:- Reheptin Suspension Batch No:- B4KOU001)
 Incomplete Review checklist attached with MLT TDS i.e. Inference of Reviewer,
Remark and Reviewed by column not filled. (Product Name:- Afresh Peach Flv.
Batch No:-E81467C18)
 MLT TDS of Dinoshake chocolate Flv. Batch No. E81469G23; Checked by sign
pending for E.coli TDS whereas reviewed by sign done.
 Overwriting observed in Coliform TI Sheet for Date of Completion i.e. DOC not
legible whereas reviewed by sign done. Product Name :-Nitework Batch No:-
E81469B09

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 12

 MLT TDS of Nitework Batch No:- E81469B09;A.R. No. Not match with MLT TDS
and FG CoA i.e. TLSHL-FPF-066/21 written instead of TLSHL-FPF-0661/21
 Incomplete TDS i.e. Sample Quantity, Date of Released, Checked by sign and
analytical record review checklist not filled or done on Platimax Tablet RT-06
Batch No. :-M PXT20003.

 Total Non conformance :- 07

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 13

Analytical Practices
 Water sample analyzed on 05/03/2021 and released om 10/03/2021 in which some
sampling point PW-05, PW-06, PW-47, PW-59, PW-31 having TNTC and PW-30 having
1000 cfu & PW-17 having 180 cfu .
 Purified water sample PW-59 fail in pH test parameter against the limit 5.50 to 7.50
 Raw material Orange Pokoe batch No 8953 analyzed on 10/03/2021, TNTC observing
in both plates on dated 12/03/2021.
 Raw material Turmeric batch No 201 analyzed on 09/03/2021, TNTC observing in
both plates on dated 12/03/2021.
 Prohance mom Batch No. 63 enriched for salmonella spp. In two different
quantity i.e. 2000 gm & 175 gm in which due to gas formation one bottle of
2000 gm has been broken inside the incubator that lead fail to performed test
for further procedure.

 Total Non conformance :- 05

Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 14
Environmental Monitoring Program
 Active Air sampling has been done microbiology lab on dated 18/03/2021 and
released on 23/03/2021 found not satisfactory as there is no any expression
observed on to the sampled plate. Plates are similar to negative control.
 Air Sampling Plates of Class 100 Area having over count as per acceptance
criteria. i.e. Pass box-L3- 45 cfu, LAF-L2:- 36 cfu, LAF-L3:- 25 cfu, BSC-L2:- 10
cfu, Passbox-L2:- 11 cfu, Passbox-L3:- 17 cfu, Center:- 11 cfu.
 Trend data not prepared for EMP carried out in Microbiology laboratory.

 Total Non conformance :- 03

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Validation/Qualification and Hold time study
 Analyst qualification procedure not covered all the test parameter performed
in Microbiology Laboratory.
 Disinfectant validation not available in microbiology laboratory.
 Disinfectant efficacy test not available in microbiology laboratory.
 Garment &assoseries sterilization hold time study not available in
microbiology laboratory.
 Fumigation Validation not available in microbiology laboratory.
 UV Efficacy Test (effectiveness study) not available in microbiology
laboratory.
 Qualification of Biological indicator procedure not available in microbiology
laboratory.

 Total
Robit Siddiki Non pvt.
Tirupati Lifesciences conformance
ltd. :- 07 08/28/2021 16
 Total No. of Non Com pliance

Trend analysis of Compliance verification in

18
Microbiology Laboratory

16

14

12

10

0
GDP BMP GLP GRP AP EMP VQHTS
Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 17
Non Compliance With respect to
Abbreviation

 GDP :- Good Documentation practices

 BMP:- Best Microbiological Practices
 GLP:- Good Laboratory Practices
 GRP :- Good Review Practices
 AP :- Analytical Procedure
 EMP :- Environmental Monitoring program
 VQHTS:- Validation & Qualification/Hold time study

Thanks
Robit Siddiki Tirupati Lifesciences pvt. ltd. 08/28/2021 18