MHRA and USFDA audit


(Manoj Singh) #1

What is difference in audit of MHRA and USFDA.


(Ankur Choudhary) #2

Both are of different country’s regulatory agencies and have their own guidelines to comply.


(Pharmabuddie) #3

Hi Manoj,
you are concerned about the auditing style or audit requirements?. However, both MHRA and USFDA are regulatory bodies of UK and USA respectively and both have their guidelines to follow. If you read between the lines they both talk about GMP and nothing else and requirements of both are almost same. GMP is just like water its H2O in india and H2O in anywhere else on this planet. This is the requirement part, if you want to know about auditing style, i want to make it in a simpler way…that MHRA approach is “I believe in you…just prove it”, however USFDA approach is “There must be some gaps…I need to find it”, Hope you are clear now. Both these are more concerned about cGMP aspect with concept of “Do whatever is right, not whatever is easy”. We always face this type of problem because we know what to do (referring guidelines, pharmacopias etc) but we dont know how to do…and there is always gap of How to do concept and all FDAs are looking that aspect only.
For more reading please refer


(Manoj Singh) #4

Thank u very much sir for valuable information.


(Ajay A) #5

But why we will give more preference to US FDA than MHRA ,Is there any reason behind that.


(Pharmabuddie) #6

Its our mindset only.
One is that US is very big market and loosing the market revenue is huge loss to business so people are more concerned.
Secondly, USFDA publish all the observations (483s) publically, where other agencies either they are not doing or at a very minimal level. Its a huge insult worldwide, also you may lose business to other regulatory agencies as well. Playing with reputation is like playing with fire.
Third, FDA guidelines are Code of Federal Regulations (LAW), any deviation to LAW is treated very seriously and a court filing will be done by FDA. Life time imprisonment and huge fine are already mentioned in their penal law.
Fourth, US treat their citizen very carefully and playing with their citizen’s life is next to crime, which most of the countries don’t bother or their law is so diluted that main culprits are always free.

I hope its well clear now.

Thanks


(Ajay A) #7

Thank you Sir, for your valuable information


(Ajay A) #8

Hi Sir,
I have a little doubt regarding the anti static garment, could you explain this one.

What is anti static garment,
Why we are using this one only,
Is there any recommendations from regulatory bodies for this one.
Tq


(Manoj Singh) #9

Anti static garments minimize the electric fields generated from their clothing. it also prevent accumulation of foreign particles to garments.


(Ajay A) #10

Tq sir