API: Active Pharmaceutical Ingredients, What is CGMP and its requirement in brief

03 of 2019

Hello Friends,

In earlier blog we have communicated about KSM and Intermediates and their role in API industry. 

Link are as below(If you have not read):

https://phamra.blogspot.com/2019/05/api-active-pharmaceutical-ingredients.html

Now we shall move forward about the industry, what is the most Important part for API industry at present. 

The person who is working in API industry, they are well known about the key point of API industry i.e., cGMP(Current Good Manufacturing Practices )

You would surprise to know that in other industry customer shall ask only about the final quality of Final Product, but in Pharmaceutical Only quality of final product is not sufficient to sell drug in Market !!   OMG

Why Why Why.........................

If the final product quality is Okay then what is the issue now?

The answer is cGMP. 

cGMP is huge topic about to discuss, we shall definitely take each and every aspects of it one by one

Actually Pharma Industry is compulsion requirement is to follow cGMP, cGMP is regulatory requirement, where c stands for Current. Therefore cGMP means Current Good Manufacturing Practices, It means you have to follow the good manufacturing process to manufacturing a drug  and the process should be in Practice or we can say the standard practice should be in Habit. 

Current means standard practice should be updated with current FDA guideline. also it should be updated with latest systems and techniques. 

You can not follow 2009 GMP for continuously you have to update your standard procedure timely for regulatory approval. And without regulatory approval you can sell your product/drum in Market. 

Now the question is why it is required by all regulatory agencies ?

If you are purchasing any Car , watch, bike ; then you can take its trial, looks etc. before purchasing these assets, but in medicine these options are not available and you can't judge medicine by it's cover, its shape , its smell. Also the testing of drug is very costly one testing cost normally in 5digit. So each and every tablet or strip testing is not possible. Testing is being conduct by a small quantity of any batch, and after conformation of results whole batch released for distribution. But the testing is done by effective highly accurate system. Mostly the Purity of drug is more than 99%. For these boundation following of cGMP during whole manufacturing is must required, to ensure manufacturing of a quality product. 

   ......Cont.

Other blogs:

1 of 2019: API: Active Pharmaceutical Ingredients Working and Experiences: Pharma Industry

Link:  https://phamra.blogspot.com/2019/05/hi-im-anupam-working-in-pharmaceutical.html

2 of 2019: API: Active Pharmaceutical Ingredients, Key starting material and its role in API

Link: https://phamra.blogspot.com/2019/05/api-active-pharmaceutical-ingredients.html

If you required more clarity on the topic than you can also comment or can Email me on anupamdubey16@gmail.com. I'll try to resolve your problems or help ! Till than Good Bye. 

API: Active Pharmaceutical Ingredients, Key starting material and its role in API

02 of 2019

Hello Friends,

In the first blog we have talked about the API and Excipients, Now we can move forward about the Industry.

Mainly the tablets are made by two forms:

1. API 

2. Formulation

Here we are understanding about the API, 

For manufacturing of any API, required Raw Materials , KSM(Key Starting material ), and Solvents.

For manufacturing of drug so many raw material are used along with water/ solvents, but  here plays an important role by KSM: Key starting material. 

As the name is, It is 'Key' material which is must required for manufacturing of drug, KSM may be one or more than one for an API. KSM is also a raw material , It is also known as 'Starting Material'. 

Now the question is why it called KSM or Starting material  ? 

An API starting material is a raw material, intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

I think you required more clarity on it .

As we know that every chemical compound or solvent having as chemical structure, therefore every raw material and solvent having a chemical structure including KSM and API is also have a chemical structure. So according to the definition A part of the chemical structure of KSM, proceeded upto manufacturing of Finish API, and you can notice this part of structure in final API, 

Several reactions going on during the manufacturing of an drug but KSM remain available as a part of structure. But the other raw materials only available in the structure for a particular reaction

Here you noticed a new word "Intermediate" in the definition, 

Intermediate is a product which is produced in between the reaction, it is isolated in between and can be hold for sometimes before starting the next stage, It is also normally analyzed by HPLC analysis to confirm the reaction completion or process is going correctly. For an example any API is produced in 5 stages, than API is produced after 5th stage, but Intermediate product isolated after 1st , 2nd , 3rd and 4th stage.  In other way we can assume them as intermediate is in-between stations of API. 

                                                                                             ......Cont.

Other blogs:

1st of 2019: API: Active Pharmaceutical Ingredients Working and Experiences: Pharma Industry

Link:  https://phamra.blogspot.com/2019/05/hi-im-anupam-working-in-pharmaceutical.html

3rd of 2019: API: Active Pharmaceutical Ingredients, What is CGMP and its requirement in brief

Link: https://phamra.blogspot.com/2019/05/api-active-pharmaceutical-ingredients_9.html

If you required more clarity on the topic than you can also comment or can Email me on anupamdubey16@gmail.com. I'll try to resolve your problems.

API: Active Pharmaceutical Ingredients Working and Experiences: Pharma Industry

01 of 2019

Hello Friends,

HI ! I'm  Working in Pharmaceutical industry since long time

Here in the blog we shall communicate about API  "Active Pharmaceutical Ingredients" Industry and the experiences.

If you are working in a Industry of Pharmaceutical , then you have to understand the meaning of API:

A substance used in a finished pharmaceutical product, intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.

If you are a fresher and going to prepared for interview in Pharma industry then you have to know about the industry and the works.

First you should be proud on the industry because it not just a work, here we manufacture LiFe SaViNg DrUgS. and API is a key life saving ingredients. Whatever the doctor of Allopathy (the treatment of disease by conventional means, i.e. with drugs having effects opposite to the symptoms) industry subscribed the drug is having API. 

Now the Question is Tablets only have APIs ?

No....

Actually Tablets are combination of API and Excipients. 

Now the question is what is Excipients ? As the word already made by "Except" mesas "Other than", It means other than API whatever in tablet is available is called Excipients. Eg. If you are taking 5 mg Cetirizine ( Antihistamine used to relieve allergy ), then in the tablet the API-Cetirizine is 5 mg in the tablet, Now if you weigh the tablet than obviously it is more than 5 mg, So whatever in the tablet other than API is used is called Excipients. Now it is more clear for you. 

And you can understand now "An excipient is a substance formulated alongside the API of a medication, It is normally use for stability to the powder api and bulking of solids , used for dilution etc.

                                                                                                    ......Cont.

More blogs:
2 of 2019: API: Active Pharmaceutical Ingredients, Key starting material and its role in API
Link:https://phamra.blogspot.com/2019/05/api-active-pharmaceutical-ingredients.html


If you required more clarity on the topic than you can also comment or can Email me on anupamdubey16@gmail.com. I'll try to resolve your problems.