A Review Article on Visual Inspection program for sterile injectable product
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
Tag: Pharma
Get copy of 483’s, Non-compliance report and GMP certificate online from Agencies
For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can also go to the FDA ORA FOIA electronic reading room and can find […]
Get Success in USFDA inspection
FDA Audit – The Do and Don’t List, How to Prepare for a FDA Inspection,FDA Basics for Industry > What should I expect during an inspection?,What to Expect When Being Inspected – FDA
FDA Inspections: Face the Challenge Through Proactive PreparationTips to Help You Prepare for an FDA Inspection,Inspection Readiness
US food and drug administration Indian site inspections: An experience,Dealing with a “difficult” FDA investigator
Strategies For Managing FDA Inspection Compliance Risks
Guidance on Gloves maintenance in Isolator and RABS
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects. Click here to read more
Tips for Successful FDA Audit
[slideshare id=85818745&doc=fdaauditreadynessguidepresbypalashdas-180107125018&type=d]
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 […]
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 […]
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, […]
Troubleshooting in pharmaceutical industry automation Vs Manual
New era of Indian Pharmaceutical industry is going to begin. Major regulatory pharmaceutical companies are under USFDA alert. Repeated/similar observation are reported against data integrity and GMP practices. Now a day’s process are dependent on the human being, however transition from human to automation is very high. But it is not like that automation can […]
Review and monitoring the sterility assurance level
One of the most critical operations in pharmaceutical manufacturing is the processing of sterile products. The production of sterile products, specifically the ones that cannot be terminally sterilized,involve complex and demanding processes to prevent the products’ contamination and require a great amount of resources. The objectives of review includes: Obtain information on operations impacting on […]