Self-Assessment

Myself Miton Chowdhury (ID:40231). I joined in ACME Laboratories Ltd. on 21st April 2016. I

am working as Executive in section Process Validation under the Validation Department.  I am
evaluating my self by considering following 5 points

1) Knowledge
2) Communication Skill
3) Extra Activity
4) How Company will be benefited by me
5) Regular Acticvity

1. Knowledge

a) Trained the new joiner about PV SOP.

b) Shared the knowledge about PV activity with intern.
c) Provide idea to update the BMR, Protocol and PO report.
d) Provide different proposal to enamul vai during preparation of PV SOP.
e) Provide idea for preparation of schedule of hold time sampling.
f) I have knowledge of preparation of protocol and report of product hold time study.
g) I have knowledge of preparation of APQR.
h) I have knowledge of investigation of deviation.
i) I have knowledge of sampling of cleaning validation.

2. Communication Skill

a) I maintain communication with my supervisor and team member and keep update
about my activity.
b) I maintain the random communication with R&D, production, warehouse and also
engineering when required for smooth production.
c) I maintain communication with production and R&D about execution of PV batch in
floor.
d) Communicate messages, ideas and expectations with responsible person for better
output.

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 3. Extra Activity

a) I have done Investigation of 3 deviation including deviation of chlorzoxazone.

b) Review the protocol deviation investigation and give correction .
c) Keep record the protocol deviation.
d) Monitoring the CAPA Implementation of protocol deviation.
e) Preparation of Change control Evaluation report.
f) Monitoring of execution and batch review of the following regulatory product:
I. Chlorzoxazone (FDA)
II. Zinc-Sulphate (WHO)
III. Metronidazole (MHRA)
IV. Hemorrhoidal Suppositories(OTC of FDA)
V. Bisacodyl Suppositories (OTC of FDA)
g) Cleaning validation sampling
h) Surveillance Audit.
i) I have prepared product list of BLS unit for the site master file.
j) I have faced QMS Audit.

4. How Company will be benefited by me

a) If required I would be provide support to Hold time study activity because I had
involved in many hold time study such as Metronidazole, Chlorzoxazone nidozox
PFS etc. which will may keep hold time study update before audit.
b) If required I would be provide support to cleaning validation because I had
experience of sampling of cleaning validation.
c) If required I would be provide support to APQR because I have experience to
prepared almost 40 APQR of both BLS and Soid Unit.
d) I have handled extreme job pressure during regulatory audits such as FDA Mock
Audit, UK-MHRA, Peru Audit, Save The Children Audit, DGDA Audit and few others
audit. So, I am capable to handle extreme pressure during audits.
e) I am able to take decision about process validation activity which will beneficial for
the company

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 5. Regular Activity

a) Checking of PO/PV protocol approval of protocol.

b) Preparation of PV report as soon as possible to reduce time of commercial
production start.
c) Checking of PO report and approval.
d) Check the checklist of before PO activity and verify that all are ok.
e) Prepared the PV checklist before PV activity
f) Before PV activity check the following things:
I. PV
g) Monitoring the PV and PO batch during manufacturing and packaging.
h) Prepare PV file after completion of Process validation.

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