The most important word in the pharmaceutical industry. Usually number of audit concluded based on the “What” and How? Few important examples are quoted below, What is the equipment requalification frequency? What is the HEPA replace frequency? What is the calibration frequency? Once you provide the reply of their next question will be, how you […]
Understanding and analysis of Equilibration Time will tell, how your cycle is consistent. Recently an article in PDA journal (1) was published to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the reduction of the equilibration time. Based on the all demonstrated study in the […]
This article is based on the practice experience gained by performing hundreds of validation test conducted on the dozen of steam sterilizer of various manufacturer. It is primarily intended that personnel who performed validation testing on steam sterilizer may benefit from these experience, and that it will assist in ensuring a high level of compliance […]
For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, for example, live organisms and radiological hazards. In such cases monitoring during routine equipment set-up operations should be […]
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
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 […]
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
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
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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 […]
