Revision - Manufacture of Sterile Medicinal Products

The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024.

Terminally Sterilized Products - Manufacturing Controls

Terminal Moist Heat Sterilization Process

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,   

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.

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.

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.