Basic errors that can be easily resolved through practice

1. COMMON WAYS TO AVOID THE
17 October
MOST FREQUENT GMP ERRORS
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Presented By :
MD. MOSARUF HOSSAN
ASSTT. PRODUCTION MANAGER

2. Intro… ..
"Most of the 483s and warning letters are issued because
of the common GMP errors. I have described common
mistakes (and ways to avoid them) in the following slides
based on the historical data and experience. Many
common good manufacturing practice errors in
pharmaceuticals can be easily avoided by following a few
simple rules. "
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3. Intro… ..
“Safety - First, Last, and Always”
"We all must observe safety ules, for our own safety and
to protect the product from contamination. We work with
ultramodern equipments, in our laboratories and facilities
that cost millions of dollars, and with exciting technology,
nevertheless, some of the products and materials we work
with are potently bio hazardous. Electricity running
through some pieces of equipment also presents a risk. “
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5. People :
People are a major source of contamination. The number of particles produced per
minute by people are-
Equipment
Friction & wear particles
Lubricants & emissions
Vibrations
Brooms, mops and dusters

6. Intro… ..
"Guards, such as on packaging equipment, are there for a
reason. Locating eyewashes, fire extinguishers, and
yourequipment "emergency stop" buttons,
company's evacuation procedures. If you
maintenance on vessels, tanks, steam lines,
learn
clean or do
or
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lyophilizers, learn the appropriate safety precautions and
follow them thoroughly without any shortcuts and
deviations. That includes company policy regarding work
orders and lockout and tag out procedures to ensure that
the equipment is not in use before you begin maintenance.

7. Example ( Symbol )
Eye Wash
Fire Extinguishers
Emergency Exit
Emergency Stop

8. Check points:
1. Personal & Product Safety:
One common GMP mistake is not wearing your
safety glasses. Your eyes are too precious, we have
to protect them.
Always wear your safety glasses, safety shoes,
respirators, and other personal protective
equipment. Take the time to think things
thoroughly. Stay alert, and trust your instinct.
Avoid situations that look potentially dangerous,
and let your supervisors or others know about it.
Read the Material Safety Data Sheets (MSDS) for
all the materials that you work in your work place.
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9. Example :

10. Check points:
2. Labelling Instructions:
vendor had
manufacturing
changed
due
Identifying and suspecting that a
the process
the change
in a raw material
in label instructions
"looked different from our routine supplies" Read all the labels
and signs carefully. Check for "released" labels. Ensure that the
material has not expired and that it’s the correct material.
Caution and warning signs in your plant should be printed in the
local language spoken in the plant.
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11. Check points:
safety
before
home,
3. Alertness in Work: Be especially careful around breaks,
when you are tired, called away, and so on. GMP regulation and
violations occur most often right before break times,
lunch, before your shift is over, when it's time to go
when someone interrupts you or breaks your train of
thought, and so on
Be especially vigilant during those times.
The most common injuries in our business
seem to be hand and back injuries, so use
proper lifting techniques, slow down, and
think about what you are about to do before
putting your hands or back at risk.
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12. Check points:
4. Gowning Practice:
Wear only appropriate clothing. Supervisors are
responsible for providing on-the-job training (including
training in proper attire, such as sterile gowning) and
then monitoring employees to make sure that they are
wearing appropriate clothing.
One common GMP error is not wearing your lab coat
while you are in the laboratory (or visitors or contractors
not wearing hair coverings, shoe coverings, lab coats,
and so on). Splashes can be dangerous and can ruin
your clothes. While visiting bulk drug plants, don't wear
designer suits or shoes.
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13. Check points:
4. Gowning Practice:
Another common error is wearing your lab coat or plant
uniform outside the building and also proceeding to
wash room with the same.
Some 483 observations noted that employees were
smoking outside of buildings while wearing their plant
uniforms. Jewellery is not allowed in certain areas.
Check with your supervisor if you're not sure..
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14. Check points:
5. Cleanliness:
Keep surfaces and equipment clean. Follow approved
cleaning procedures, and use approved cleaning
solutions, People may become sick and in the most
serious case due to cleaning was inadequate, and the
cleaning process had never been validated. One of the
first things that investigators or visitors notice while
they visit your plant is the facility's general cleanliness.
Ensure that each equipment was cleaned by checking
the "Cleaned Equipment" status tag and equipment
logbook. If possible, open the equipment and look
inside to make sure that no rinse solvent was
accidentally left behind.
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15. Check points:
6. Health & Hygiene:
Wash your hands. Most pharmaceutical plants
have signs in the bathrooms reminding
employees to wash their hands before
returning to the plant or work area. If you've
ever put your hand on a plate and cultured
the bacteria present, you know that bacteria
are everywhere, in large quantities, although
omnipresent in life, they are not something
that any one of us wants in our medicines or
injectables.
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16. Check points:
7. Report an Illness: Working personnel should notify their
supervisors when they have a cold or any viral infections. It is a
GMP requirement that employees and temporary employees do
this. On those days when you're not feeling up to par, you can
be assigned to attend GMP classes, revise SOPs, or catch up on
your scintillating GMP reading, such has articles like this one.
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17. Check points:
8. Use of Approved Material: Use only Approved & Released
raw materials, packaging components, and labels. Use no expired materials.
Under cGMPs, only released materials can be used in all clinical and commercial lots of
product. A common error is to store expired materials with current materials. Proper
segregation is required and Remove and/or destroy all expired materials.
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18. Check points:
9. Committing Mistakes due to shortfall of TIME:
Even though the pace of our industry is fast, and everyone has
more to do than they can possibly get done, everyone deserves
the time to think things through. Hence, think before plan and
plan before doing the work or committing the time lines...
All the time, everybody will be rushed in their work area, where
there is greatest possibility of committing the critical mistakes in
work area which hampers the GMP status of the product / activity.
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19. Check points:
10. Documentation:
Always fill in the blanks. Record all requested
information. If it’s truly not applicable, write
N/A; your initials, and the date. If pages or
sections of forms are not applicable, line
through them, write N/A, your initials, and the
date. The correct information must be entered
on batch records, equipment logbooks, and
test result forms, otherwise, your QA /
Regulatory Inspector will find out with you soon
why you didn't complete the work and
sometimes it leads to in complete
documentation for the activity is been done.
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20. Basic Documentation Rules

21. Check points:
11. Use Indelible Ink:
The industry standard is black / blue indelible ink because it
photocopies well and does not smear. Pencil is unacceptable
because it smears easily and can be erased and also it releases
graphite particles which cannot be controlled in clean rooms
especially.
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22. Check points:
12.Banish the
correction fluid:
Using correction fluid is prohibited.
13.Line through, Initial, and
date all changes:
The correct way to make a change is to line
through the error once using your indelible
ink pen, clearly write the correction above or
beside it, and initial and date the correction.
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23. Example :

24. Check points:
14. Constructive Thoughts
/Actions:
Take action to make things better. we may
reach a conclusion faster than someone else.
Have the courage to bring up things that need
to be improved. Be the responsible employee
who picks the piece of paper from the floor
rather than steps over it.
As your move up in your career, people
are going to trust you with information that is
confidential and sensitive. You must honour
their confidences but also take action.
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25. Check points:
15. Calibration Status: Ensure
that equipment is calibrated before using it.
Equipment that must be calibrated in a
manufacturing or laboratory environment
typically has an equipment calibration tag on
it which indicates the date
the equipment was last calibrated, who did the
calibration, and next calibration due date.
Check to make sure that your equipment is
within calibration before you use it. Otherwise,
your results or measurements could be
inaccurate.
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26. Check points:
16. Numbering System:
Record ID, part, lot, document, revision, and other control numbers. When
something goes wrong with a product lot, trying to determine the true source
of the problem is often like solving a mystery. The GMPs require that you
assign and use unique numbers on each lot of your raw materials, reagents,
documents, and all lots of produced product to permit traceability should there
ever be a problem.
While, filling out a batch record or recording your results, record equipment,
lot, sample, reference sample, and document and revision numbers.
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27. Check points:
17. Eatables are Prohibited in Work area: Do not bring
food, gum, tobacco, or house plants into production and
laboratory areas. A common GMP error is bringing drinks into a
laboratory. Smoking, eating, and drinking are prohibited in a
GMP facility. You do not want to have food inside a GMP facility
because rodents and other pests will try to enter the area to get
the food. A beetle can bore through 0.125 inch of solid plastic to
get to food or the glucose or sucrose stored on pallets in your
warehouse. Houseplants may have insects on their soil and
leaves.
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28. Check points:

29. Check points:
18. Pest & Rodent Control:
Check your pest control devices frequently with
the ID no and location of it. If you use an
outside pest control service, test it by placing a
plastic mouse in one of the traps. If the service
doesn't find it, it's not doing a thorough job
inspecting and cleaning the traps. Because rats
like to run along walls - they do not see well,
and they feel safer against a wall - rodent traps
should be placed along walls.
Antidotes should be available in the site in
case of any situation of inhaling or taking it
inside.
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30. Check points:
19. Thorough Review of Document:
Before signing on any document / record,
check for data accuracy, for completeness,
and correct calculations. In our industry, a
signature is a legal and an ethical
responsibility. If you have signature
authority and are asked to sign on
something, you must do to the best of your
ability, review it thoroughly and completely,
make sure that everything that needs to
be attached is attached, and make sure
that all calculations are correct. Never sign
something without thoroughly reviewing it
first. Never sign something that you know
to be wrong. Get it corrected and then sign
it.
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31. Check points:
20. Duplication of Data is Prohibited:
Record data directly on the appropriate form or notebook. Do
not write original data on scrap paper, napkins, or paper towels
and then transfer the information to the appropriate form or
notebook. If you accidentally record your data on a piece of
scrap paper, staple it to the form or notebook, because it is
original data. Always attach printouts and labels where
indicated. Never throw away original data.
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32. Check points:
21. Secondary Check:
Have another person perform double /
secondary check as Indicated in the batch record / Document / Record.
Double checks are mandatory for critical steps, like weighing and adding
raw materials, because people have discovered that historically those are
problematic areas.
Secondary check means that one person performs the work while
another person observes and makes any suggestions or corrections.
Individuals then sign or initial the batch record where indicated. GMPs
require that you have sufficient staff to do this.
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33. Check points:
22. Proper closing of inter
linked Doors:
Keep shipping,receiving, and other doors
closed. A common error is to leave shipping
and receiving doors open after a delivery
has arrived - an open invitation for pests of
all kinds. Owls, snakes, rats, and mice have
been found in warehouses looking for food,
water, and shelter. A field mouse only needs
0.25 inch to get under a door, so check the
bottom of your outside doors. If there is a
gap, you could be inviting a rodent problem.
The cGMPs require that you have an
effective pest control program; keeping your
receiving doors closed will help.
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34. Check points:
23. Continues reading / reviewing of SOP’s:
Read and become familiar with all SOPs and other documents
that relate to your work. You must know your SOP’s.
A common 483 observation continues to be "Firm failed to
follow its own SOP." If an SOP needs to be revised, tell your
supervisor and offer to help revise it and get it approved.
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35. Conclusion:
Apart from the above mentioned, following also to be
required to ensure avoiding the GMP Errors like Self
discipline, Attitude in work area, Co-operation, Team work,
Cordial relations in work area with supervisors and with
sub-ordinates, loyal to the company / position or
designation and finally professional attire in our part.
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36. Page
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Thank You
Any Question