GMP Inspection Process
The Inspection
Notes for group session 2
Group 3: BS Pharmacy 2A
Stephanie Breguera
Edgar Manuelle Canta
Charmaine Camille Castro
OBSERVATION
1.1.3
The masses used to calibrate the balances had not been certified. (The 1kg one had sticky
material adhering to it).
DEFECT CATEGORY
Major Defect
QUESTIONS
How would you report these to the company?
If you found out that one of the masses used to calibrate the balances had not been
certified, one should report to the quality assurance managers/supervisor because
they are the one who manages and maintain that things are calibrated and correct.
Calibration is important because it helps ensure accurate measurements, and accurate
measurements are foundational to the quality, safety and innovation of most products
and services we use and rely on every day and also improves assurance of precise
measurements required in research, development, and innovation, as well as the
production of millions of products and services worldwide.
What immediate action and follow-up is required?
Equipment that are not calibrated on a regular basis or doesn't have maintenance
should be taken out of service and be clearly labeled (out of service- out of use). This
will prevent others to further use these equipment until repaired and shown by
calibration or test to perform correctly.
All equipment should be certified and must filled for certification to ensure the
quality and standard of the equipment that they will used. Laboratory personnel shall
examine the equipment and if there is any error Procedure for Corrective Action is
required to be implemented. From then calibration records shall be maintained and
associated with the unique identifier of each piece of equipment and also provide a
policy that every equipment should be always clean before and after using it and
store it in a proper place.
OBSERVATION
1.3.4
In batch nnn of product xx out-of-specification results for refractive index and for cineol
were each reported as a “pass” In another example, eucalyptus raw material lots no nn
with pinene and cineol limits of 9 – 14% and 80 – 85% respectively were passed with
results of pinene 7% and cineol 88% and the raw material lot no. xxx had a cineol peak,
apparently only measuring 2% and apparently mislabeled.
DEFECT CATEGORY
Major Defect
QUESTIONS
How would you report these to the company?
This is a major defect wherein there was a mislabeled product. The product is useless
because of mislabeling. I will disclose this to the production manager and quality
control manager along with the material inspection section and quality coordination
office. I will ask the material inspection how come the material was mislabeled
wherein they are responsible for sampling and examining all the raw materials. I will
also ask the quality coordination office why is so they did not double-check the
labeling of the product whereas their main responsibility is to document all of the
products.
What immediate action and follow-up is required?
I will immediately put a yellow sticker on the product so that this will hold in the
quarantine area for further inspection. Once confirmed that the product was
mislabeled the previous sticker will be removed and changed to a red sticker which
means the product was rejected or been useless. I will recommend holding the
production to be able to trace what was wrong. So that it saves money, helps to
control quality, reduces manufacturing costs, reduces rejection losses, and assign
causes for the production of a defective product.
OBSERVATION
1.7.3
There was no evidence for zxc capsules indicating that there was requirement in the
stability programme for disintegration testing.
DEFECT CATEGORY
Critical Defect
QUESTIONS
How would you report these to the company?
If you observed that there was no evidence for zxc capsules indicating that there was
requirement in the stability programme for disintegration testing immediately report.
To avoid non-functional product and life-threatening that may lead to adverse effect
and serious health risk. Disintegration is often a pharmacopoeial testing requirement
for the vast majority of solid dosage forms. It provides critical safety data on drug
bio-availability in the body without having to utilize in vivo methods. Establishing
consistency and uniformity across all batches using this method is a critical quality
control step. Each pharmacopoeia specifies its own standard conditions for the
performance of disintegration testing.
What immediate action and follow-up is required?
The immediate action and follow-up is to inform the Quality Control Department in
the Manufacturing Company of the zxc capsules to forcefully stop the production of
that batch of certain drugs to avoid the possible miss-dose of the patient.
Conduct an inspection and further investigation to assure the safety performance of
the product.
OBSERVATION
4.8
There was no mirror in the changing room to check that operator's hair covering was
properly fitting.
DEFECT CATEGORY
Minor Defect
QUESTIONS
How would you report these to the company?
Notify the factory manager or hygiene manager if they have one, since they are the
one who is responsible for supporting good Health and Safety practices within the
Manufacturing process, through the development of the cleaning processes and
equipment used, and training provided. Specially in those rooms used for changing
proper attire of personnel in the factory.
What immediate action and follow-up is required?
Every room used for changing the attires of the employees must be check and
immediately provide or install a mirror inside the room so that they can see if the
attires are worn correctly. All employees that has long hairs should be shortened, all
employees must be check before they go to their working stations to ensure
cleanliness and practice proper hygiene.
OBSERVATION
12.1
Although a lot of GMP training is carried out there is no overarching SOP.
DEFECT CATEGORY
Critical Defect
QUESTIONS
How would you report these to the company?
As per inspecting it was a critical defect because they neglected to comply with the
SOP. Without SOP the manufacturing company is not organized and we know that
Standard operating procedure (SOP) gives us accuracy, precision, quality, safety, and
efficacy of a product. SOP along with the good manufacturing procedure is vital
especially when it comes to a manufacturing company. So when this is neglected, it
would be life-threatening. Therefore, I will straight away inform the factory manager
so that it will give action immediately.
What immediate action and follow-up are required?
I will hold the production at once and inspect those products that were produced to
be able to lessen the damage that it will cause. All of the products produced will be
put on a yellow sticker or for a quarantine period. Before the workers can operate
again to normal, they should undergo training again to be able to fully understand the
importance of GMP and SOP then that is the time where they can return to their
work.
