Can anybody explain the entire process of QA (Quality Assurance) in Pharma manufacturing?
please explain me anybody the process of QA. As I searched the entire web and not even one site is able to explain the process. even wikipedia is also failed to expalin. I know that Quality Assurance covers all activities from design, development, production, installation, servicing and documentation. But, I need stepwise explaination. So, If anybody knows the process kindly give me the answer.
Answer:
Please visit the following web-sites :
whqlibdoc.who.int/publications...
www.portal.nelm.nhs.uk/QA
www.ateliervision.de/gmp/quali...
strQuery=pharmaceutical+qualit...
www.ateliervision.de/gmp/quali...
You will get what you require.
HELLO
GIVING ANSWER IS VERY BIG FOR ENTIRE Q A
I THINK IT IS FOR ISO PURPOSE. THEN YOU HAVE
TO APPROACH AN ISO CONSULANTS.
IF YOU NEED MORE DETAILS ?????!!!
I CAN.....
Quality Assurance, as the name implies, assures that the quality of the product they produce passed standards and can be released to market. In Pharma setting, the QA process is quite strict; otherwise, the drug that they produce can harm instead of cure.
Usually, QA is a one big division in the company which comprises of sub groups: Chemistry Lab Dept, Microbiological Lab Dept, Physical Lab Dept, New Products Development Dept, Technical Services Dept, CGMP (Current Good Manufacturing Practices) Dept, and Documentation Dept. The labs do routine testing to ensure that correct quantity of the ingredients are added in the product, nutrients/active ingredients are on the right levels, no pathogens in the product, no foreign materials in the product, and that the product is of the right texture, density, etc. The New Products Development Dept do research to come up with new product lines and/or improve existing product lines. The Technical Services Dept is responsible for Validation Technology and Change Management in the plant. The CGMP Dept is responsible for maintaining the high standard of manufacturing the products. And the Documentation Dept is responsible for maintaining good documentation practices, following regulations, and keeping all the records.
Of course, these are just simple description. Details of their jobs are more complicated and need more time to explain.
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Answer:
Please visit the following web-sites :
whqlibdoc.who.int/publications...
www.portal.nelm.nhs.uk/QA
www.ateliervision.de/gmp/quali...
strQuery=pharmaceutical+qualit...
www.ateliervision.de/gmp/quali...
You will get what you require.
HELLO
GIVING ANSWER IS VERY BIG FOR ENTIRE Q A
I THINK IT IS FOR ISO PURPOSE. THEN YOU HAVE
TO APPROACH AN ISO CONSULANTS.
IF YOU NEED MORE DETAILS ?????!!!
I CAN.....
Quality Assurance, as the name implies, assures that the quality of the product they produce passed standards and can be released to market. In Pharma setting, the QA process is quite strict; otherwise, the drug that they produce can harm instead of cure.
Usually, QA is a one big division in the company which comprises of sub groups: Chemistry Lab Dept, Microbiological Lab Dept, Physical Lab Dept, New Products Development Dept, Technical Services Dept, CGMP (Current Good Manufacturing Practices) Dept, and Documentation Dept. The labs do routine testing to ensure that correct quantity of the ingredients are added in the product, nutrients/active ingredients are on the right levels, no pathogens in the product, no foreign materials in the product, and that the product is of the right texture, density, etc. The New Products Development Dept do research to come up with new product lines and/or improve existing product lines. The Technical Services Dept is responsible for Validation Technology and Change Management in the plant. The CGMP Dept is responsible for maintaining the high standard of manufacturing the products. And the Documentation Dept is responsible for maintaining good documentation practices, following regulations, and keeping all the records.
Of course, these are just simple description. Details of their jobs are more complicated and need more time to explain.
The answers post by the user, for information only, FunQA.com does not guarantee the right.
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