MedSpace

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REPEATABILITY:

REPEATABILITY Aim: To determine the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogenous sample. Method: 1.      Using test method, prepare 6 sample solutions and record the accurate sample weights. 2.       The assay according to a method, injecting each sample solution in duplicate. 3.       Calculate the content of each sample as % and determine the mean and % RSD. Acceptance Criteria: The % RSD of the standard content of replicate (Six) samples must not exceed 2%. Results: (Name of Tablet )   ___mg  -    batch _____ (if available) Sample No. Active Ingredient (%) 1 2 3 4 5 6 Mean SD %RSD Conclusion: ________________________________________________________________________________________

PRECISION OF INJECTION Aim: To confirm the repeatability of retention time and peak area for replicate (Six) injections of Respective standard Method:        Prepare a standard solution using the procedure described in Method. Record the standard weight and potency. Perform six injections of the standard solution, record the area and retention time for each of the standard’s peak. Calculate the mean and % RSD. Acceptance Criteria: The % RSD of peak areas should be less than 2% and that of retention time less than 1%.

When the product demand does not allow for a complete clean up after each batch, a campaign cleaning validation must be conducted.   A back to back cleaning is performed between batches in a campaign, and a complete cleaning at the end of a campaign. Sampling of the equipment is performed after the last batch in a campaign, and all test results must meet predetermined acceptance criteria as per campaign cleaning validation protocol.   Samples for residual active may be taken after back to back cleanings where possible, for information only . Microbiology samples may be taken after back to back cleanings in a campaign to ensure that there is no excessive microbial growth on the equipment.

Failure Mode and Effect Analysis (FMEA): A failure modes and effects analysis (FMEA) is a procedure in product development and operations management for analysis of potential failure modes within a system for classification of the severity and likelihood of the failures. A successful FMEA activity helps a team to identify potential failure modes based on past experience with similar products or processes, enabling the team to design those failures out of the system with the minimum of effort and resource expenditure, thereby reducing development time and costs. Effects analysis refers to studying the consequences of those failures.