USCGMP
ULTIMATE SOURCE OF CURRENT GOOD MANUFACTURING PRACTICES
Thursday, August 25, 2022
Revision - Manufacture of Sterile Medicinal Products
Friday, January 14, 2022
Sunday, January 9, 2022
Thursday, August 17, 2017
Compliance to regulatory requirements in Pharmaceutical industries
Current regulatory inspection is come up with lots of recommendations.
In this article will be discussing regarding the different regulatory requirements.
This is the time to evaluate our existing procedure and mitigating the risk.
Here will discuss about the recommendation which received different regulatory
authority. Keep your eyes to our blog
and check whether you are complying to below mentioned recommendations,
Monday, August 14, 2017
Global Challenges for Indian Pharmaceutical Industry
The Indian pharma
industry is on a good growth path and is likely to be in the top 10 global
markets by value by 2020. High burden of disease, good economic growth leading
to higher disposable incomes, improvements in healthcare infrastructure and
improved healthcare financing are driving growth in the domestic market.
Pharma companies are growing both
organically and inorganically. Inorganic growth is happening through licensing
and partnerships as high valuation of assets is making acquisitions difficult.
Further, companies are organically improving their operations and productivity
by increasing field force sizes, penetrating in Tier II and III cities and by
expanding their product portfolios.
Tuesday, July 4, 2017
Recipe control in manufacturing system
Now a day’s regulators looking for control on the product
/system recipe. Recipes are very critical
part of process. Because process are control through validated recipe. If firm calming
that their system complying 21 CFR par 11/EU annex 11, in that case they should
ensure that their system is capable for following mentioned control,
a) System
should available with the audit trial and it should capture in case any change
in individual recipe
b) Recipe
edition, modification and deletion to be assign to only administrator, these
mentioned options should not accessible to other authorization level.
Sunday, July 2, 2017
Design, Operation, Qualification and maintenance of Isolator
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling.
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