NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

DEPARTMEN NON-COMPLIANCE OBSERVED ACTIONS TO BE TAKEN RESPONSIBILITY

T
Maintenance: 1.Three Used/Expired fire extinguisher Used/Expired fire extinguisher cylinders MM/GM
cylinders seen in the department need to be refilled

2. The generator house is congested and littered with The generator house should be MM/GM
unserviceable/ repairable equipment parts, junks and decongested by auditing of the
out of use machines. abandoned parts and equipment by
sorting out the serviceable, non-
3. serviceable, junks and out of use items
4. for appropriate action and alternative
5. space be provided to keep out of use
6. machines and parts
7.
3. Leakages of fuel observed from the generator’s fuel No leakage of fuel should be allowed in MM
supply line. generator house get it fixed

4.Uniforms are not well arranged in the office looks Uniforms should be well arranged and MM
unkempt. the office should be well kept.

5.Housekeepers not doing their job properly. Housekeeper work should be checked Supervisor

6.The plastic chair used by manager should be The manager’s chair should be changed. GM
changed.

Store 1. Finished goods quarantine has no release Tags should be placed on each batch of Store officer
date tag on them finished goods quarantine indicating date
of release.

2.Raw materials were stored in finished goods’ Raw materials should be removed from
quarantine. FP quarantine immediate

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 NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

There should be proper3.non-disarray

Finished products were not well arranged for
arrangement within the ware
easyhouse
access and identification. STORE

4.High concentration of dust in the warehouse. Dust extractors should be installed GM

5.Some cartons were found bursted by the corner edge. Number of cartons in a stack that is safe
should be investigated and adhered to. STORE/QC

6.The raw materials were not arranged orderly. The raw materials should be properly
stacked away from the wall and must all STORE
be on pallet

7.Used dirty cartons were packed together with These dirty cartons should be removed
new ones in ware house. immediately to prevent mix-up
STORE
Rearrangement should be done to pave
8.The packaging materials in warehouse is jam way for easy access and exit
packed Blocking an exit and accessibility STORE
The ware house should be well
9.The warehouse is poorly illuminated. Illuminated.
STORE/IM
Used raw materials and virgin materials SUPERVISOR
10. Virgin raw materials were co-stacked with used should be properly arranged and
materials with used materials raw material stores. separated. STORE/INJECTION
MOULDING
SUPERVISOR
E.O 1.Sterilization machine not properly cleaned Machine should be properly cleaned. SUPERVISOR
Sterilization:
2.Leakages observed at the water pump area Leakages should be blocked. GM/MM

3.House- keepers cleaning materials not well kept Housekeepers working tools should be SUPERVISOR
properly kept and concealed
4.Water heating tank not regularly cleaned Cleaning of the water tank should not be MM

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NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

annually but biannually and there should

be protocol and record for each cleaning
operation

5. maintenance of the EO machine brain box not yet Proper maintenance of the E.O
done sterilization machine mostly the brain
box should be sought out and put into GM/TOP
action with records maintained. MANAGEMENT

The section should be properly

6. A lot of organized mix-ups is going on here demarcated and organized GM/STORE

E.O section should be reconstructed to

7.Storing of sterilized materials in wrong place is safety standard with demarcation as GM/TOP
common here with a very thin or no line of advised by expert. MANAGEMENT
demarcation between sterilized and non-sterilized
products
Housekeepers should improve on their
8.House keeper not doing their job properly here job in the section. ADMIN/
SUPERVISOR
Revisitation of maintenance preventive
9.Impact of preventive maintenance mild here schedule GM

Admin 1. Departmental list of workers (total number of staff All to be complied with
department: should be made available)
2.Current Staff medical test reports should be made HR
available.
3.Retainership letter with hospital: HR
4.S.O.P for exit and entry, for grievances procedure,
5.SOP for covid-19, should all be made available: HR
6.SOP for recruitment
Sop for employee health, safety and hygiene Retainership letter with hospital should HR
Sop for personnel training be made available: HR

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NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

Attendance list with signature of attendant of training S.O.P for exit and entry, for grievances,
Training schedule and assessment etc for covid-19, should all be made
available.
Most of the soap dispensers are either not available at
the appropriate locations or nonfunctional or empty Soap dispenser needs to be fixed at the admin
without soap appropriate places and soap must also be
made available at all times

Production Male changing room:

department: 1. Clothes littering the room Clothes should be well arranged on the PM
hanger

2. The sink is dirty and the floor littered with water need thorough washing and mobbing up Admin/PM
of littered water always
3. Space constraint. more space needed

Female changing room:

1.Clothes littering the floor. Clothes should be well arranged on the
hanger provided and more hangers should PM/admin/
be provided procurement
Needle assembly:
1. Congestion with components everywhere. Mop up the components through
proactive planning
2. personnel clothes are dirty. Personnel needs to appear neat
always/their uniform needs to be changed PM/SUPERVISOR
to another color
3. Machine not well cleaned. Machines should be properly cleaned

4. Needle store not well arranged and also littered The needle store should be properly
Reject needles arranged and rid of unusable components

Level of stacking should be reduced

Injection moulding:

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NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

1. Level of stacking is too high might affect the New collection trays should be provided.
components. PM/SUPERVISOR
2.broken and cellotaped receiving trays in use More extractor fans needed.
Crushing room: The floor needs to be repaired and well
1. Temperature is too high at 35oC. cleaned.
2. Dirty floor with component and crevices. Storing of raw materials more than what
is needed should be discontinued.
3. Crushing room is over congested with materials SUPERVISOR
that are not immediately needed
Components should be well arranged
and properly stacked.
Syringe assembly:
1. Components are not well arranged but scattered New napkins should be provided. PM/SUPERVISOR
2. Too much/wrong stacking method

3. Dirty, blackish napkins observed Machines should be properly kept and the PM/
broken parts should be fixed PROCUREMENT
Printing machine: Machine is not properly cleaned
and some feeder hoper covers are broken; This should be properly cleaned with PM/MM
bleaching materials (i.e coke and hypo).
Blister packing machine: New napkins should be provided.
1.Machine working area is dirty with printing ink; GM/PM/MM
The air pressure to needle assembly
should be increased.
2. Dirty Napkins PM/procurement
Unused cartons should be moved out.
Packaging section: Bad bulb should be replaced PM/SUPERVISOR
1.The air pressure to 10ml packing section is not
enough The area should be well arranged and
2. Packaging section is filled up with unused illuminated
cartons
3. Illumination is poor because some bulbs are not
working PM/MM

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NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

4. The packaging area Is not well arranged.

1. Paper back Note books are being used for in- Hard cover should be used for in-process SP
Physioc process results as against hard cover result taking.
hemical 2. Parameters checking are not enough. Parameters should keep increasing.
Lab.: 3. The laboratory is congested. More space needed. SP
4. Forms are not properly and fully filled. Forms should be properly and fully filled
A pH meter should be provided
5. No functional PH meter. Table top hygrometer (digital) needs to GM/QCM
6. Table top hygrometer is faulty. be replaced

Good chairs are needed.

7. Bad chairs. SOPs should be put in place for all GM
8. SOPs are not properly placed. machines and STPs. QCM
Soap dispenser should be made available
9. No soap dispenser in the required locations. GM

There should be Proper checking of drugs

10. The first aid kit is not properly checked for and medical consumables in the first aid
update of contents kit SUPERVISOR

Microbiology:
1. No soap dispenser Should be made available GM
2. Space constraint More space needed GM
3. Incubators in the lab are not enough. More incubators needed
4. LAL reagent in the lab is expired LAL reagent should be made available GM

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NAFDAC MOCK INSPECTION FIRST INTERNAL AUDIT, DATED 02/04/2022

Pyrogen 1. Bushy area Needs to be cleared GM

2. Clothing curtain in the test are being eaten window blind should be provided GM/PROCUREMENT
up by rabbits. for test room

3. Using of analog clock in the test room is Digital clock is needed GM/PROCUREMENT
not proper
4. Using of digital thermometer is injuring the Infrared thermometer is needed GM/PROCUREMENT
rabbit
5. Congestion of cages More cages are needed. GM
6. No enough space More space is needed
7. No curtain in the office window Curttain should be made available GM/ PROCUREMENT
for office window
8. Ceiling fans are dirty Cleaning of ceiling fans should be Admin
regular
9. Broken Net door observed The net door needs to be fixed PROCUREMENT