Saturday, May 3, 2008

FDA Validation compliance

Q - difference between GMP & cGMP ?
Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products. An added benefit of prefixing their legislation is that the FDA have made their standards immediately identifiable; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). By saying that firm X employs cGMP indicates that they are following 21 CFR 210 and 211 and no other.
Also i have listed some of the good trainings which you can view online

Related Training -
Efficient Computer System Validation - 10 Easy Steps
Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Master Planning for Computer System Validation
Risk Based Validation of Software and Computer Systems
Assessment of Computer System Risk as a Basis for Validation
Verification vs. Validation

Q -how do you calibrate a thermometer ?

Ans -for calibration of the thermometer put thge standard and the TUC (both should be of same range)in the silicon oil bath and slowly raise the temperature and check the temperature difference between both of thew thermometers and note the difference,set some criteria for the temperatiure difference

Q -Please explain the worst case in cleaning validation with examples.

Ans -worst case in cleaning validation is the study of product preparing the matrix in part a, b, c, part a as selection of product based on its solubility and min. strength, part b mean mac calculation by considering the selected product in part a, and part c mean equipment train contact surface area calculation, swab aea or rinse volume, and calculating for ppm allowable limit per equipment per product in respective mfg. area.
in other ways it can be studied by grouping the products in to the matrix as high to high, low to low , low to high and high to low.

Related Training - Cleaning Validation - Chemical & Microbiological Aspects

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