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Personnel & Training – Checklist

No.
Question
Options
1
Is the Organizational Chart updated and displayed?
Yes
No
N/A
2
Are all Units have an adequate number of Staff?
Yes
<10% not ok
>=10% not ok
No
N/A
3
Is each of the Units under proper supervision?
Yes
<10% not ok
>=10% not ok
No
N/A
4
Is the Qualification and Experience of each person corresponding with the Job description?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
5
Are managerial responsibilities of each technical personnel specified in writing with the job description?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
6
Is an updated Technical Staff List documented and available with all the information like- Name, Qualification, Years of Experience of Responsible Pharmacists, a Chemist in Production, Quality Assurance, and Control, etc.?
All ok
<10% not ok
>=10% not ok
Not ok at all
N/A
7
Is periodic check done to confirm that no Gaps or unexplained overlap of responsibilities present for each personnel?
All done
<10% not done
>=10% not done
Not done at all
N/A
8
Are all the Training Materials available and enclosed?
Yes
<10% not ok
>=10% not ok
No
N/A
9
Are the GMP(Good Manufacturing Practice) training syllabus and materials available and enclosed?
Yes
No
N/A
10
Are the SOPs (Standard Operating Procedure) for the training of staff available?
Yes
<10% not ok
>=10% not ok
No
N/A
11
Are every Staff get the required training in the time of joining?
Yes
<10% not ok
>=10% not ok
No
N/A
12
Are every Staff get the required training whenever needed during their job tenure?
Yes
<10% not ok
>=10% not ok
No
N/A
13
Are all the staff getting updated training for GMP(Good Manufacturing Practice) periodically?
Yes
<10% not ok
>=10% not ok
No
N/A
14
Are the Records of all training details given to every in-house staff available and enclosed?
Yes
<10% not ok
>=10% not ok
No
N/A
15
All the Training assessed by proper assessment/questionnaire?
Yes
No
N/A
16
Is specific training provided to the staff working in Clean Areas, Highly Active and Toxic Materials Handled Areas, etc.?
Yes
No
N/A
17
Is hiring every staff followed by a Medical Examination?
Yes
No
N/A
18
Is Medical Checks for all the employees done periodically during their job tenure?
Yes
No
N/A
19
Is Medical Assistance available always during the working hours?
Yes
No
N/A
20
If any staff got any Health Issue, does he/she immediately removed from the worksite until he/she recovered fully?
Yes
No
N/A
21
Is a proper system available for Reporting Back after illness?
Yes
No
N/A
22
Are every Staff wearing Clean Uniforms, Hair Covering Caps, and other protective equipment?
Yes
No
N/A
23
Are there proper Washing, Changing, and Resting areas available for the staff?
Yes
No
N/A
24
Proper instruction provided to each staff about how to wear Protective Clothes, and when to change?
Yes
No
N/A
25
Are the adequate number of clean Uniforms and other Protective Equipment for the staff available?
Yes
No
N/A
26
Are the adequate number of all Protective Equipment available for the visitors/outside personnel entering in production areas?
Yes
No
N/A