Category Archives: Validation

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 … Continue reading

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GAMP 5 computer system categorization

Software Classification Categories Comparison of software categories in GAMP 4 and GAMP 5 As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the … Continue reading

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Discussion for establishment of risk based approach on airflow visualization in cleanrooms

Smoke study or air flow visualization is the important factor in clean room qualification. My query to some experts were as following 1. What will be the requalification frequency for Smoke study?2. If there is no significant changes in the … Continue reading

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Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas?

  Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face. Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact … Continue reading

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Few qualification facts of Sterilization and Depyrogenation tunnel

How to calculate conveyor speed in Tunnel? Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory … Continue reading

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Design BMS (Building Management System) in Pharmaceuticals Industries

Building Management System (BMS) is monitor and control the parameters of HVAC system like temperature, relative humidity and air quantity to maintain a controlled environment.

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Qualifying Disinfection for Critical Environments and Cleanrooms

How are Disinfection Qualification Studies Regulated? The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized … Continue reading

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Start Clean Room Qualification

Clean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a … Continue reading

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Water System Design In Pharmaceutical Industry In Sterile Injectable Facility

1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System

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Equipment cleaning and use log as per regulatory requirment

CFR – Code of Federal Regulations Title 21 [Code of Federal Regulations][Title 21, Volume 4][Revised as of April 1, 2013][CITE: 21CFR211] TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C–DRUGS: GENERAL  PART 211 CURRENT GOOD … Continue reading

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