By Steve Dobbs, Jane Miller, Julian Gilbey
Written to compare the contents of the Cambridge syllabus. information 2 corresponds to unit S2. It covers the Poisson distribution, linear combos of random variables, non-stop random variables, sampling and estimation, and speculation checks.
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Additional info for Advanced Level Mathematics: Statistics 2
1 Inspectional Approach The FDA notes that the inspectional approach for coverage of a BPC operation is the same whether or not that the BPC is referenced as an active ingredient in a pending application. The purpose, operational limitations, and validation of the critical processing steps of a production process should be examined to determine that the firm adequately controls such steps to ensure that the process works consistently. Overall, the inspection must determine the manufacturer’s capability to deliver a product that consistently meets the specifications of the bulk drug substance that the finished dosage form manufacturer listed in the application or the product needed for research purposes.
If the need for special storage conditions exists, for example, protection from light, such restrictions should be placed on the labeling. It should be noted that reserve samples of the released BPCs should be retained for one year after distribution is complete or for one year after the expiration or reevaluation date. In addition, documentation of the BPC manufacturing process should include a written description of the process and production records similar to those required for dosage form production.
4 Disintegration Testing Similar to dissolution testing, disintegration testing has a two-stage sample plan. In the first stage (S1 ) of disintegration testing, six dosage units are tested. The requirements are met if all six units disintegrate completely. Complete disintegration is defined as that state in which any residual of the unit, except fragments of an insoluble coating or capsule shell, that may remain on the test apparatus screen is a short mass with no palpably firm core. If one or two units fail to disintegrate completely, repeat the test on 12 additional units at the second stage (S2 ).