SL.No.

Observation
1 Pictorial Diagram of Entrance and Exit
2 Room Temperature and Humidity Controlled
3 All machine Calibration Tag
4 Daily functional log book maintain
pH meter
5 GLP Training
6 House Keeping Practice 1. Waste management
7 SOP List and Review Date
STP List and it reviewed evaluated thoroughly and
8
Testing lead time
9 HPLC Colum list and performance test
10 Hazard or toxic Chemical Disposal system
11 Emergency Exit not Present
12 Instrument Log Book Printed Instrument Log Book Need
Reagent, VS,TS Need to arrange Alphabetically for
13 Reagent Arrangement need to update
easy tracing
14 Instrument cleaning after work doesn’t practice
Sophisticated Instrument GC, TOC Service off now
15
and Status Tag
Backdated Expired file, Source sample, and
16 Need to Disposal for clean QC and freeing the space
Retention sample full of wastage
Are any deviation from the specs, record or
17 justification? OOS result found and what are action
taken
18 Retest policy
Microbiology
o Cleaning: daily, weekly, monthly
1. Biological Safety Cabinets- Cleaning SOP Check
o Check for air flow
o Temperature Monitoring- daily
Incubators:
o Cleaning- monthly
o day of use
pH meters
o 3 levels of buffer solutions
SOP List
1.any have SOP action taken in case water analysis
failure
2. any have SOP action taken in case endotoxin o
failure
3. any have SOP action taken in case environmental
monitoring failure
Validation record for D.HS available (Dry heat
Sterilizer) Frequency 6 month organism Bacillius o
subtillis spore
Disposal of Media as per sop o
Test for disinfectant effectiveness are studied and
established in different concentration , where use o
in cleaning purpose