QUALITY CONTROL DEPARTMENT

END OF MONTH REPORT FOR DECEMBER 2022

From: Quality Control Manager
To: General Manager
Ref: HMA/QCM/MR/Vol.1/022/21
Date: JANUARY 1ST, 2023
Subject: DECEMBER, 2022 End of the Month Report

A. PHYSICOCHEMICAL UNIT
S/N ACTIVITIES DETAILS OF ACTIVITIES REMARKS

1. INPUT MATERIALS

i. Raw materials:
i Polypropylene 3 tons was supplied. All samples tested complied with
Solubility, acidity and reducing specifications of relevant
substance tests were carried out references.

2. INTERMEDIATE
COMPONENTS:
i Injection Molding:
 5ml Barrel 44 batches sampled and analyzed Blockages, Short Shots, Burn
 5ml Plunger 33 batches sampled and analyzed Marks, side leakage and flash, and
bad actuation force were discovered
 2ml Barrel 24 batches sampled and analyzed
early at different stages. Sorted out
 2ml Plunger 26 batches sampled and analyzed and anomalies corrected to
23 batches sampled and analyzed compliance level with relevant
 5ml Cap
13 batches sampled and analyzed specifications.
 2ml Cap 17 batches sampled and analyzed
 21G Hub

ii Printing:
40batches sampled and analyzed Printing defects manifested as
 5ml Barrel
19 batches sampled and analyzed
incorrect placement of Fiducial line,
 2ml Barrel non-clarity of divisions of nominal
volume and smudges, volume
verifications were checked for at the
early stage and any non-conformity
sorted out and anomalies corrected
to compliance level with relevant
specifications
 iii Syringe Assembly: 41 batches sampled and analyzed Any escapee Leakages, Blockages,
19 batches sampled and analyzed bad actuation force, bad printing, or
 5ml
any other non-conformity
 2ml discovered at this stage, were sorted
out and anomalies corrected to
compliance level with relevant
specifications

iv Assembled Needle:
 21G Needle 23 batches sampled and analyzed Samples were checked for bond
 23G Needle 12 batches sampled and analyzed strength; penetration tests and no
 18G Needle 3 batches sampled and analyzed non-compliance observed.

CHEMICAL ANALYSIS OF
FINISHED PRODUCTS:
 10ml Syringe & Needle 11 batches sampled and analyzed
3.  5ml Syringe & Needle All the batches analyzed for
41 batches sampled and analyzed
chemical parameters of reducing
 2ml Syringe & Needle 25 batches sampled and analyzed substance and Acidity/Alkalinity
 23G Needle 6 batches sampled and analyzed complied with specifications of
 21G Needle 7 batches sampled and analyzed relevant references.
 18G Needle 2 batches sampled and analyzed
 22G Needle 1 batch sampled and analyzed

PHYSICAL AND
DIMENSIONAL ANALYSIS
OF FINISHED PRODUCTS:
4.
 10ml Syringe & Needle 11 batches sampled and analyzed
 5ml Syringe & Needle 41 batches sampled and analyzed All the batches analyzed complied
 2ml Syringe & Needle 25 batches sampled and analyzed with relevant specifications for the
 21G Needle 6 batches sampled and analyzed parameters tested i.e. weight,
 23G Needle 7 batches sampled and analyzed diameter, dead space for needle and
 22G Needle 2 batches sampled and analyzed syringe etc.
 18G Needle 1 batches sampled and analyzed
 B. MICOROBIOLOGY UNIT
S/N ACTIVITIES DETAILS OF ACTIVITIES REMARKS

1. Sterility Test:
93 Batches were sampled and
analyzed which comprises of
 10ml Syringe & Needle 11 batches sampled and analyzed
 5ml Syringe & Needle 87 batches passed the sterility test while
41 batches sampled and analyzed
 2ml Syringe & Needle 6 batches are in progress
25 batches sampled and analyzed
 23G Needle 6 batches sampled and analyzed
 21G Needle 7 batches sampled and analyzed
 18G Needle 2 batches sampled and analyzed
 22G Needle 1 batches sampled and analyzed

100 batches of finished goods

were released:
 10ml Syringe & Needle 22 batches Released All batches passed sterility test
 5ml Syringe & Needle 45 batches Released
 2ml Syringe & Needle 17 batches Released
 23G Needle 8 batches Released
 21G Needle 5 batches Released
 18G Needle 2 batches Released
 22G Needle 1 batches Released
2. Environmental Control Test:

i. Temperature and Humidity 9 locations sampled (Physicochemical The Temperature and Humidity of Needle
lab, Assembly clean room, Injection Assembly A&B complies (i.e. 80%:90%
Molding A&B, Needle Assembly A&B, respectively of the sample collected during
Microbiology Sterility A & B, Air lock) the period under review while Injection
Molding A temperature and humidity
complies (i.e. 90%:95%) injection moulding
B Temperature failed throughout while
Humidity complies above 80%. Sterility
Room A &B Temperature and Humidity
complies (i.e. 85%:90%), Clean room
Temperature and humidity complies (i.e.
90%:75%) while physicochemical Lab &
Airlock Buffer Temperature and Humidity
complies above 90% respectively during the
period under review.

ii. Pressure Differential 14 locations sampled

(physicochemical/clean room, air lock/ Needle Assembly A/Injection Molding B
clean Room, Assembly clean room / failed in 95% of the samples taken in the
injection molding hall A, air lock/male period under review and Ware house/Needle
changing room, air lock / female Assembly B failed in 85% of the samples
changing room, female changing room/ collected during the period under review,
cross over bench, Sterility A & B/Buffer Male changing room/Cross over bench failed
Room, Microbiology passage/main in 80% of the samples taken in the period
outside passage, injection molding under review and Female changing
A/needle assembly A and Male Changing room/Cross over bench failed in 85% of the
room/ Cross-over Bench, Needle
samples collected during the period under
Assembly A/ injection molding B, ware
review while other locations complies above
house/needle assembly B.
50% during the period under review.
ii. Air particles concentration 13 locations sampled (Assembly Clean Clean Room failed above 95% of the
Room, physicochemical, Injection samples collected during the period under
molding A&B, Male & Female Changing review, Needle Assembly A&B, Injection
Room, Needle Assembly A&B, Air lock, moulding A&B failed above 70% of the
Sterility A&B, Laminar Air-flow cabinet samples taken during the period under
A & B). review, Male & Female Changing Room
failed above 50% of the samples taken
during the period under review while other
locations complies for most part of the period
under review.

iii. Illumination and Noise Levels 11 locations (Sterility Room A&B, All locations complied with specifications
Physicochemical Lab, Needle Assembly for the 2 parameters
A&B, Syringe Assembly, Male Changing
& Female Changing Room, Injection
Molding Hall A&B and Airlock room.

15 locations were sampled for the routine

iv. Air Volume Delivery Only 7 out of 15 locations complies with
Air Volume Check (Female changing
specifications (Female changing room A,
room A&B, Male Changing Room A&B,
Male changing room A, Laminar Airflow
Buffer Air Lock, Clean room,
A&B Buffer Air Lock, Sterility Room B)
Physicochemical lab, Injection Molding
while other locations failed to comply with
A, Needle Assembly I&II, Incubation
specification.
room, Sterility Room A&B and Laminar
Airflow A&B).

18 locations were sampled for routine For Routine Check: Only 3 out of 18
v. Environmental Bioburden
environmental, Pre-fumigation and Post- locations complies with specification
fumigation check (i.e. Sterility A&B, (Sterility A&B and Blister Section) while
Physicochemical lab, Male changing other locations failed to comply with
room, Female changing room, Packaging specification for routine bioburden check
I&II, Main passage, Quarantine 1&2, For Pre & Post fumigation:
Crushing, Ware house, Needle Assembly All 18 locations failed to comply with
1&2, Blister Section, Injection moulding specifications during the pre-fumigation
A&B and Syringe Assembly environmental bioburden check.
However, after fumigation 13 out of 18
location complied with specification, while 5
locations failed to comply with specification
(Male changing room, packaging 1&2,
Quarantine 2 and warehouse).
The above indicates 72.2% effectiveness of
fumigation.
S/ ACTIVITIES DETAILS REMARKS ACTION
N

vi . Personnel
Hygiene: 1 personnel each was sampled from One (2) out of 15 personnel sampled Enforcement of the usage
a Finger Dabbling 15 locations (i.e. Printing Section, (microbiologist & Printing operator) of IPA and training of
Syringe Assembly, Blister Section, complies with specification while other personnel on importance
Physicochemical, Housekeeping personnel failed to comply with of personal hygiene
unit, Injection Moulding 1&2, specification.
Crushing, Needle Assembly 1&2,
Packaging 1&2, Microbiology lab
and Maintenance unit).

Enforcement of the usage

1 personnel each was sampled from of IPA and training of
One (1) out of Ten personnel complies
b Glove Print 10 locations (i.e. Needle Assembly
with specification (Microbiologist) while personnel on importance
A&B Physicochemical lab, of personal hygiene
other failed to comply with specification.
Injection Molding A&B, Blister
Section, Syringe Assembly,
Packaging 1&2, and Microbiology).

1 personnel each was sampled from Only (4) personnel tested Negative for the
c Pathogen Test 15 locations (i.e. Printing Section, presence of [Link] (i.e. Injection
(Staphylococcus, Syringe Assembly, Blister Section Enforcement of the usage
Moulding 1, Packaging 1&2 and
[Link] & Other Physicochemical lab, of IPA and training of
Microbiologist).
Enteric bacteria) Housekeeping, Injection Molding personnel on importance
Only (3) out of 15 personnel complies
1&2, Crushing, Needle Assembly of personal hygiene
with specification (i.e. Microbiology lab,
A&B Packaging Unit 1&2, E.O, packaging 2 and Physicochemical Lab)
Microbiology Lab and maintenance while other failed to comply with
Unit). specification by showing the presence of
Staphylococcus aureus

7 out of 15 personnel complies with

specification (i.e. Maintenance Unit,
Needle 2, Microbiology Lab, Printing,
Syringe Assembly, Blister section and
Physicochemical Lab) while other failed
to comply with specification with results
showing the presence of other enteric
organisms.

9 Machines were sampled for All 9 machines complies with

d Equipment equipment hygiene check (i.e. specification.
Swab Laminar Flow A&B, Needle
Machine 001&002 e002, Injection
Molding 001&010, Blister Machine
001 and Syringe Machine)

Only (2) Locations complies with Increase in the frequency

e Floor Swab 11 locations were sampled for of cleaning and the usage
specification. (i.e. Physicochemical &
analysis (i.e. Needle Assembly 1&2, Female Changing Room) of the right disinfectant-
Cleanroom, Physicochemical lab, water ratio.
Male changing room, Female
changing room, Main Passage.
Injection Molding 1&2, and
Packaging 1&2)
 C. PYROGEN LABORATORY UNIT

S/N ACTIVITIES DETAILS REMARKS

Pyrogen Test:
 10ml Syringe & Needle 11 batches sampled and analyzed All the batches showed
 5ml Syringe & Needle 41 batches sampled and analyzed compliance.
 2ml Syringe & Needle 25 batches sampled and analyzed
 23G Needle 6 batches sampled and analyzed
 21G Needle 7 batches sampled and analyzed
 18G Needle 2 batches sampled and analyzed
 22G Needle 1 batches sampled and analyzed

Summary:
 The relevant SOP has been invoked to investigate the failure of the sterility test of these batches and the
investigation has been concluded and the report has been sent to the GED, GMD, GM, GHR and the Quality
Consultant of the Company in person of Mr. Omosebi. The next thing is for the management to arrange for
the discussion of the findings and the CAPA and other recommendations there in good time. This is because
the factors that were responsible for the failures past are still there in the system being obvious from the
present report. URGENT ACTIONS NEEDED! URGENT ACTIONS NEEDED!! URGENT ACTIONS
NEEDED!!! THIS IS A RED FLAG I WARNED.
 There were defects at injection molding ranging from short shot 5ml plunger and 10ml plunger 5ml barrel,
23G, 21G Hub blockages, flash and burn mark were common during the period under review. All these were
discovered. Bad Printing presented as blurred, smudges, fiducial line misplacement, breaking of lines of
division at the Barrel Printing, Non-clearance of Blistered printing and Blistered Leakage at Blistering
Sections were common during the period under review due to lack of right cartridge.
 At syringe assembly, there were syringe leakages most especially 5ml syringe due to short shot on plunger
been used. All these were encountered during the period under review and corrected as the case was during
last review.
 Two batches of Polypropylene Raw Material that failed reducing substance test were retested during the
period under review and they still failed. A further analysis by a third party was approved by the GM and the
test is still failed reducing substance, and certificate has been submitted to Gm.
 There is need for smoke detector inside the clean room. This has been raised severally. This is for reminder
purpose.
 The capacity extension of our facility is on-going, areas of potential risks have been identified. The
validation master plan and the reviewed site master file are work in progress awaiting some documents such
as drainage plan and Mechanical Electrical plan. It will be of great benefit if the stakeholders in the
construction of facility extension can meet together to dot the i’s and cross the t’s before the seal up of the
construction. It is very crucial to have a central components storage room if our material and personnel flow
will be effective in reducing cross contamination. The following recent observations were however made (1)
the bath rooms that are being constructed for non-clean room personnel has its waste water channel right in
front of the factory; this can be a source of uncontrollable offensive odour in the very near future, similarly
 the other set of bathrooms do not also have a soak-away. Nearly 50% of bath taking are accompanied with
excretion which can be a source of fouling the environment. For a reminder this is a sterile facility. (2)
Material and personnel movement is an important factor in ensuring sterility in a facility like ours, there is a
concern that this has not been adequately addressed.
 The environmental bioburden of our facility is on the rise again, the environmental bioburden of our facility
for the month of December deteriorated as only 8 locations complies with specification after the fumigation
exercise. There is reduction in the total bioburden of every location however, this reduction is not significant
enough for it to comply with the specifications in some locations. This could be as a result of some locations
being jam-packed thereby hindering the diffusion of the fumigation agent, also the use of unsealed and
unlabeled fumigation chemical (potassium permanganate) could be a factor and the harmattan season could
also contribute to the high level of fungi population observed.
 The Blistering Film recorded high Microbial load when analyzed. Proper storage of this material is
recommended to prevent contamination of our product thereby reducing product bioburden.
 The HVAC line system needs overhauling which should include the cleaning of the vents as only 29% of
them are performing optimally. Validation of the HVAC system is also recommended.
 There is high level of unwholesome practices in the handling of materials used in manufacturing. This is
more pronounced in raw material stores and crushing sections.
 Reports shows that there is slight improvement in the personnel hygiene of our workers when compared to
the previous month. However, the presence of microorganism and pathogens are still predominant which
could be as a result of non-compliance with the use of IPA by personnel.

SIGNED: Mayomi A.I.