Hi, It's
Md. Saddam Nawaz,
a pharmaceutical QMS, QbD, data integrity and validation practitioner from Bangladesh. I'm helping life science organizations rapidly access the industry's best practice in every stage of the product lifecycle.
Check section to learn more about my core areas of expertise.
Md. Saddam Nawaz,
a pharmaceutical QMS, QbD, data integrity and validation practitioner from Bangladesh. I'm helping life science organizations rapidly access the industry's best practice in every stage of the product lifecycle.
Check section to learn more about my core areas of expertise.
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Welcome to "GMP GEEK".
This site is intended to create a unique platform to share 21st Century Pharmaceutical Manufacturing related issues with the GEEK professionals, as well as with the NOVICES who are newbie in a Pharmaceutical GMP (Good Manufacturing Practice) Environment.
Who is GMP GEEK (GG)?
There are two definitions for the word GEEK:
-a person who is socially awkward and unpopular : a usually intelligent person who does not fit in with other people
-a person who is very interested in and knows a lot about a particular field or activity
So, we may call them “GMP GEEK” who are bright, likewise subject matter expert (SME) on GMP topics (e.g. process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance).
Also, there are two definitions for the word NOVICE:
The first is that a novice is a person new to or inexperienced in a field. Yes, this site is addressed to novices in good manufacturing practice. A novice is also described as a person who has entered a religious order and is under probation before taking vows. Perhaps this is a stretch, but many GMP professionals (particularly the older ones) believe that the field of GMP is not unlike a religious order—once entered, you are in it for keeps. And when is your probation over? What do you have to know before you are confirmed? When is a novice no longer a novice? Are we all novices forever because there is always some- thing more to comprehend, to learn, and then apply? Do even the high priests of the discipline understand the mechanism of biological equivalence of two proprietary preparations of a drug? Such meditations are probably way too philosophical. So let’s say to the novice GMP professional: please just learn what’s in this site, and you will be ready to take your vows.
This site is intended to create a unique platform to share 21st Century Pharmaceutical Manufacturing related issues with the GEEK professionals, as well as with the NOVICES who are newbie in a Pharmaceutical GMP (Good Manufacturing Practice) Environment.
Who is GMP GEEK (GG)?
There are two definitions for the word GEEK:
-a person who is socially awkward and unpopular : a usually intelligent person who does not fit in with other people
-a person who is very interested in and knows a lot about a particular field or activity
So, we may call them “GMP GEEK” who are bright, likewise subject matter expert (SME) on GMP topics (e.g. process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance).
Also, there are two definitions for the word NOVICE:
The first is that a novice is a person new to or inexperienced in a field. Yes, this site is addressed to novices in good manufacturing practice. A novice is also described as a person who has entered a religious order and is under probation before taking vows. Perhaps this is a stretch, but many GMP professionals (particularly the older ones) believe that the field of GMP is not unlike a religious order—once entered, you are in it for keeps. And when is your probation over? What do you have to know before you are confirmed? When is a novice no longer a novice? Are we all novices forever because there is always some- thing more to comprehend, to learn, and then apply? Do even the high priests of the discipline understand the mechanism of biological equivalence of two proprietary preparations of a drug? Such meditations are probably way too philosophical. So let’s say to the novice GMP professional: please just learn what’s in this site, and you will be ready to take your vows.