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that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.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.
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that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.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.
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.