June 14, 2020

7 GOLDEN LESSON LEARN FROM A CHILD





It is inevitable that as we get older, we would like to become more childlike. The solution is sort of obvious. Children are free from responsibilities, can make mistakes & escape with it and are still learning the beats of this wonder called “Life”! Isn’t it beautiful? Who wouldn’t want to be a child? Well, today we are getting to mention what we will learn from children. Well, it's never too late to try!

1. Hearts Speak more powerfully then Mind:

Have you ever seen a children thinking an excessive amount of before speaking? this is often because most youngsters speak from their hearts & not their minds. Don’t you “think” it's an excellent quality to adapt? numerous of our relationships suffer because we are unable to place our feelings to words and only consider meeting others’ expectations.

2. Purity:

Kids are innocent. this is often mostly because they're distant from the “corrupt” adult life. But what truly makes adulting seem “corrupt” is that the incontrovertible fact that we stop becoming childlike. We drop our innocence within the big bad world then expect great things to happen to us. Can such negativity ever reap positive results? as long as we stop watching the planet around us with such cynical viewpoint can we regain our innocence.

3. Clarity:

With kids, it's simply a yes or a no. there's no mid-way. Now, in fact it’ll be stupid to expect such transparency in adult-life. But we should always aim for such clarity in making our important life decisions a minimum of . Kids don’t second-guess or enter the grey area. they're very sure of what they need and the way to urge it. If we could too, half our problems would get away .

4. Lot of Questions:

Children are never quiet. this is often mostly because they question tons . They question everything. Why is that the sky blue? Why can’t I fly? Why can’t I eat chocolate everyday? Where is Pluto? Why can’t I touch the Moon? it's endless! However, we never question our circumstances. Why can’t I be happy? Why do things need to be so bad? Why am I so limited? Well, if we question our lives, we may strive to seek out a solution too!

5. Learning is never ending process:

Kids are always hungry to find out more & more every day . they need to understand everything. this is often why they're so ego-less. They don’t care about what others think, they need to find out everything there's to life. If you actually believe it, a number of the talents that you simply are a master of today is because you started learning them in class or at a really young age. But what we fail to understand is that it's never too late to find out .

6. Free Energy:

Have you ever seen a children getting uninterested in playing around? No? Why is that? Because kids are free & filled with energy. In thought also as physically. they will mould themselves into whatever they need to be. But adults are always shying away. We are always physically uptight and are making excuses. Unless we've such childish freedom, we will never truly be happy!

7. Satisfaction is a Myth:

Kids are restless which is why they're never satisfied. They always want more & more & more..and then some more! this is often one among the foremost important qualities to imbibe. Never be satisfied. Learn to require more from life – because you deserve it all – then some more!

Hope this post will rejuvenate you and provides you the motivation to be more childlike. If you think that of more such qualities that we will learn from kids, please do share on our comments section. Let’s help one another out!

June 11, 2020

GxP in Pharmaceuticals.

What is GxP?

GxP is the bio/pharmaceutical quality guidelines and regulations created to make sure that bio/pharmaceutical products are safe, meet their intended use, confirm to quality processes during manufacturing, control, storage, and distribution.

"GxP were established by USFDA."

USFDA is the pharmaceutical regulatory governing body who are responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.*
*Source: https://www.fda.gov/about-fda/what-we-do

GxP is acronym which elaborate as follow:
G = Stands for Good 
x = Stands for Variable of application like M is for Manufacturing, D is for distribution, E is for Engineering, L is for Laboratory, C is for Clinical, R is for Review, S is for storage etc. 
P = Stands for Practice

Guideline mostly focus on below criteria:
  • Data Integrity: Making sure that the data is accurate (ALCOA)
  • Accountability: Who has done activity and when the activity has performed and it's sole responsibility.
  • Traceability: Easily identified and proper back track to make sure to resolve problems instantly.

Below are the Industries Impacted by GxP:
  • Pharma,
  • Food,
  • Medical devices, and
  • Cosmetics.

GxP contains varied sets of regulations, but GCP, GLP, and GMP are the most common:

GMP (GOOD MANUFACTURING PRACTICE)
GMP consolidates the practices required to comply with the guidelines recommended by agencies controlling authorisation and licensing for the manufacture and sale of food , drugs and active pharmaceutical products;
Such standards include minimum requirements that must be met by a pharmaceutical or food product manufacturer to ensure that the goods are of high quality and do not pose a danger to the consumer or patients.

GCP (GOOD CLINICAL PRACTICE)
GCP is an international quality standard established by the International Conference on Harmonization ( ICH), an international body that sets guidelines that can be transposed by governments into legislation for human clinical trials.
It controls human experimentation done in medical sciences for the sake of advancement and serves as a quality benchmark as well as a moderator to keep such experimentation in check.

GLP (GOOD LABORATORY PRACTICE)
These are the standards set by the FDA for non-clinical laboratory tests and studies performed to assess the product's safety and efficacy.
GLPs are a set of standards that specify the structure for a non-clinical study and state how it should be performed, measured, published, etc.
For a product to be sold on any market , a must comply with the GxP regulations.

7 GOLDEN LESSON LEARN FROM A CHILD

It is inevitable that as we get older, we would like to become more childlike. The soluti...