Sr.

No Tube Filling : Inspection Remarks

Whether all the machines are labeled with correct status?

Are the operators wearing full sleeve garments /gloves?

Is the room clean and free of any evidence of other products?

Is there more than one product in the room?

Are the following In-process controls being exercised by QA

personnel:

a) Weight variation

b) Crimping & embossing check

c) Cap tightening check

Whether the Operation & Cleaning log-books for the Filling

Machine maintained & updated:
 Is the filling record being compiled concurrently?

BOTTLE FILLING : INSPECTION

Is there any packing / raw material or finished goods belonging

to other products present in the department?

Does the filling machine bear appropriate label?

Is the fill volume checked?

Are the operators wearing full sleeve garments /gloves?

Is the room clean and free of any evidence of other products?

Are the following In-process controls being exercised by QA

personnel:

a) Weight variation
 b) Crimping & embossing check

c) Cap tightening check

Whether the Operation & Cleaning log-books for the Filling

Machine maintained & updated:

JAR FILLING : INSPECTION

Is there any packing / raw material or finished goods belonging

to other products present in the department?

Does the filling machine bear appropriate label?

Is the fill volume checked?

Are the operators wearing full sleeve garments /gloves?

Is the room clean and free of any evidence of other products?

 Are the following In-process controls being exercised by QA
personnel:

a) Weight variation

b) Crimping & embossing check

c) Cap tightening check

Whether the Operation & Cleaning log-books for the Filling

Machine maintained & updated:

KIT FILLING : INSPECTION

Is there any packing / raw material or finished goods belonging

to other products present in the department?

Does the filling machine bear appropriate label?

Is the fill volume checked?

Are the operators wearing full sleeve garments /gloves?

Is the room clean and free of any evidence of other products?

Are the following In-process controls being exercised by QA

personnel:

a) Weight variation

b) Crimping & embossing check

c) Cap tightening check

Whether the Operation & Cleaning log-books for the Filling

Machine maintained & updated:

Miscellaneous : Production Floor Inspection

Ampoules Preparation done in separate Space/Room

Are footwears and uniforms dedicated to components

preparation area?

Is record of compressed air filters cleaning maintained?

Is record for DM water filters cleaning maintained and updated

Is SOP for Cleaning the machine operating instructions

written?

Are operators using hand gloves?

Are operators trained for the job?

Is batch preparation record compiled concurrently?

What is the maximum temperature in filling rooms?

What is the humidity in filling room?

 Are operators training program record maintained?

Is supervisors training programme record maintained?

Are the equipments cleaned properly after change of product

Are log books for operation and cleaning of

Equipments/Machines maintained separately and properly and
Updated

PACKING INSPECTION

Check packing records at random. Line clearance for batch /

product changeover SOP.

Is pack profile for all products available?

 Inspection Check List for Storage of Packing Materials

Are incoming material and components quarantine until

approved for use?

Are all materials stored off the floor.

Are materials spaced to allow for cleaning and labeling?

Are the packing materials of different products properly

segregated

Is the area adequate for physical separation between different

materials to prevent mix-ups?

Is material stored as per their status: quarantine, approved /

released or rejected?

Are the quarantine, approved / released or rejected area

completely demarcated?
 Whether each pack holding packing material appropriately
labelled?

Are the printed labels kept under lock and key?

Is there a separate arrangement for printing of particulars as per

coding record?

Are coded materials kept separately?

Is there a stock rotation program if yes, is it followed.

Crosscheck five random readings.

Is the FIFO & FEFO system being followed?

Are the SOPs for the following maintained & Updated:

a) Cleaning of packing material stores area
b) Handling of Obsolete (Rejected Printed/ Unprinted)
packing material
c) Issue of packing Materials and transfer of issued materials
from packaging material store to production
Are the labels with complete information and duly signed by
QC and written clear and legible text?

Is sampling done as per the sampling plan by QC?

Is there a provision for dispensing of extra or additional

material is it followed?

Check if the list of employees is available and updated.

Observer dispensing operation:

i. Is it conducted by authorized person under supervision of
production /QA?
ii) All the calculations / weights checked by production / QA?
iii) Observe the area after completion of dispensing?

Is the movement of man & material movement logical within

stores and from stores to the production area?

Is there a SOP for return of excess material e.g. online rejects

etc. from the production to stores?
 Inspection Check List for Documentation / Quality Assurance

Are master copies of all the SOPs kept lock & Key?

Are process deviations recorded?

Is the disposition of deviation being done by department head
of QA?
Are corrective actions taken and recorded?

Does the current lists of all the SOPs available?

Is the current list of approved vendors available?

Is the list of vendor’s segregated material wise?
Are the vendors approved by QA verified the records?

Is the list of RM / PM available & verify the code numbers?

Are market complaints processed and recorded by QA?

Verify from the records and check the action taken on any 3
complaints.
Does a person of QA Deptt. remain present at the time of
dispensing of RM?

Are the Production and packing processes checked during

production?
 Inspection Check List for Personnel

Verify if the list of employees is current.

Is there a SOP for induction program of new recruits, Check

records.

Verify if responsibilities of key personnel’s are clearly

designated and documented.

Check induction and medical records of new joinee, select any

2 or 3 employees.

Is a list of personnel and the responsibilities available?

Is the first aid box provided at all the key locations?

Inspection Check List for Premises including personnel facilities & Sanitation / Housekeeping

Is the facility maintained in a clean and sanitary condition?

Are the buildings constructed to facilitate adequate cleaning,

sanitation and pest/rodent control?

Verify, if schedule for cleaning and sanitation are available for:

walls, floors, ceiling and fixtures?

Are all the wash basins of all the change Rooms kept neat &
clean?

Check if cleaning records are maintained?

Are the cleaning material kept at their proper places?

Check if cleaning records are maintained?

 What is the level hygiene: Good (G)/Excellent
(E)/Satisfactory (S)/Bad (B) (especially check nail, hair, etc.)

Is the canteen or eating room facility neat and clean?

Check if fire extinguishers are installed, checked, properly

labeled and are fire safety drills performed as per schedule?

Is written procedure describing safety measures is available?

Are lighting and ventilation adequate to facilitate comfortable

working?

Check if the emergency exits in the building are maintained

and unobstructed?

Check if toilet cleaning and maintenance record are

maintained,

Availability of soap, hot and cold water air dryers, single

service towels?
Is waste being segregated as – plastics, organic, metal etc.?
 Maintenance of buildings and Equipments

Are written procedure established for maintenance of equipment

and utilities?

Are utilities maintain and monitored as per schedule?

Is the preventive maintenance of major utilities being

performed?

Air Handling Units (AHUs)

Compressed Air
Vacuum Pump
Air Conditioners
Chiller Plant
Boiler
All Filling Machines
Revender /Printers
Carton Packing Machine/Shrink Tunnel

Is the cleaning procedure available for?

Cooling towers

Chiller plant

Air handling units / duct / dampers

Raw / DM Water storage tanks

Are the services pipes clearly marked & indicate direction of

flow (air, water, vacuum, LPG, Compressed Air)?
Is there a schedule for the maintenance of service pipes? If yes,
check the records.

Is there a SOP on building maintenance? If yes, check the

records?

Does calibration planner is available and check for the

compliance?

Is the preventive Maintenance of all the Machine done

according to their preventive maintenance schedule and
records maintained?

Is the proper record regarding re-filling and monthly

verification of conditions of Fire Extinguishers installed at
various places maintained properly?

Is the record of breakdown of machines maintained properly?

Are the STP & ETP logbooks maintained?

Are the Logbooks of all the DM Water tanks maintained?

Are the Logbooks of all the Air Compressors maintained?

Is the Logbook of the Electricity Meter Reading maintained?

Are the Logbooks of Operation & service of Generators

maintained?

Is the Logbook of Operation & service of Boiler maintained?

Is the Logbook of DM Water Plant Charging maintained?

Is the list of critical spare parts for all the machines /

equipment’s available?

Check the list of critical spares for equipment; one each from
production and utility.
Check the stock ledger for the spare parts.
Is the validation / calibration of equipment’s / gauges
performed as per schedule

Check the validation / calibration records of minimum three

equipment

Check the record for job orders received and executed?

 Inspection Check List for Equipment

Does all equipments used for manufacturing / processing are

Suitable in their size / capacity?

Are the location of the equipment / machines in the facility

acceptable?

Are the equipment / machines properly design and installed?

Are machine surfaces that direct contact the materials or

finished goods non-reactive, non-absorptive and non-adaptive
so as not to affect the product?

Is the ideal equipment stored in a designated area?

Is equipment cleaned promptly after used?

Are written operating procedures available for each equipment

used in manufacturing / processing or holding of components,
in process material or finished product?
Does the startup procedure ensure that equipment is thoroughly
cleaned?

Are all equipments have an identification no.?

Do the major equipment have usage logs, cleaning logs,

preventive and maintenance logs.

Are the relevant components of the machines calibrated and

records maintained?
 Inspection Check List for Production and In-process Control

Is the procedure for line clearance followed?

Are the in process checks being verified by QA personnel

Are there any physical separation between packaging lines?

Is the procedure for process deviation implemented?

Check records

Does the machine indicate batch details and stage of processing

of the batch?
 Inspection Check List for Quality Control

Is the lab neat and orderly with enough space for working
space?

Lab Reagents:
Reagents bottles properly labeled (Name, date of preparation,
use before date, prepared by)

Reagents bottle properly closed

Placed as per temperature requirements

Is there a ledger maintained for stock of chemicals

Instrument Calibration / Maintenance

Check out three instruments, check calibration SOP and

records.

Is there a specific program schedule of calibration?

All the instruments been calibrated in the operational range?

 Testing and Analysis :

Are all tests being performed as per Standard Test Procedure?

Are the testing report signed and dated by analyst?
Are the testing records counter checked by QC in-charge
before release of sample?

Is there a SOP on out of specification results?

Are the glass wares cleaned properly?

Are the testing records maintained regularly giving all the

required particulars?

Is daily pH and conductivity of Purified water record

maintained?

Is chemical analysis of Purified water done daily and record

maintained?

Are all the instruments kept on shelves in orderly manner?

Is Controlled samples register maintained?

Is the Room temperature record of Control sample room
maintained?