2.1 Analytical Chemist – Quality Control – Responsible for indicating analytical values and rounding figures in accordance with these guidelines. Note: The general rules for rounding and reporting numerical values are as follows (exceptions to these rules are those indicated otherwise in the monograph, SOP or TSP). When rounded up to the next third decimal place, values become zero 1.1 Establish a procedure for establishing guidelines for reporting analytical values and rounding figures. Some examples of the implementation of the above principles during rounding are given in the table below: Each time rounded down, the general leaflets of the USP, the European Pharmacopoeia (Ph. Eur), the British Pharmacopoeia (BP) should be mentioned to ensure that rounding is not misleading to change an erroneous result into a success result. (Because the limit has no decimal places, the rounded value cannot have a decimal place.) If the results are to be expressed in both mg and % (e.g. the recorded unrounded value is taken into account in calculating the above two values for the declaration. The indication in mg (or other similar units) must be made to the decimal place which takes into account the value in % in the specification. 3.2.4.
Any known impurity content above the LOQ limit value shall be taken into account in the calculation of total impurities. At the end of the COA, the extension of the LOQ, LOD and Disconsideration values is mentioned. (The number corresponding to the last decimal place of the limit. Rounding the value to the right of the value) (This also applies to values “below the non-compliance limit”. If the value is below the non-conformance limit, it must be clearly indicated on the certificate of authenticity that the same value is “below the non-conformance limit.”) 3.2.3 If the impurity value is above the LOD limit and below the LOQ, you should not consider calculating total impurities and individual impurities. Pingback: SOP for Non-Calibration Handling (OOC) – Pharma Beginners Note: However, these clauses do not apply to middleweights. Conversion of the number of units into weight (kg/g, etc.): 3.5. The analytical values or test results shall be expressed in units as specified in Annex – 1. 3) In 4.0961 = 4, 0, 9, 6 and 1, significant numbers The percentage value of the dosage shall be specified with a single digit after the decimal point, unless otherwise specified. Pingback: SOP for reviewing analytical reports and raw data – Pharma Beginners 3.2 If the calculated value contains more digits to one decimal place than the specified limit, the figures shall be rounded to one decimal place as described below.
3.1 Once the analysis is complete, the analytical chemist calculates the analytical result in the worksheet and compares it to the limits specified in the specification. In addition, indicate that these should be excluded for the reporting/calculation of related total substances. For example: in 354 = 3, 5 and 4 are significant numbers 3.3 If the method of analysis or test requires quantification, the result of the analysis shall be expressed as the numerical value observed in this case. 3.2.1. Rounding is done by taking into account a single digit to the decimal place to the right of the last digit of the limit print, as shown in the figure below. · If the result is < 50 ppm, report it to 1 decimal place Since the number of significant numbers in the component with the smallest number of significant numbers (here 21) is 2, the result must also be rounded to 2 significant numbers. Therefore, the result should be expressed as 90. Accordingly, the proposed number of decimal places to be indicated for different dosages of the drug is presented below (e.g. in mg): Read also: SOP for Audit Trail Check and Privilege Policy If the results are below the LOQ, the numerical value must be provided with the text: "BLQ or below the LOQ" and in addition, Specify the LOQ value as a footnote in the COA/datasheet.
Do not use the (more than), < (less than) cannot be used. Instead, the same is reported in words like,. 2) In 0.0961 = 0 (to the right of the decimal point), 9, 6 and 1 are significant numbers 3.2 The calculated analytical values shall be indicated in worksheets, certificates of authenticity and raw data sheets, as shown in the following table: Rounding and reporting method for selected key analytical parameters 2.2 Controller/Quality Control Officer – Responsible for verifying the values declared in accordance with the SOPs. 3.2.2 If the figure is less than 5, it shall be deleted and the preceding paragraph shall remain unchanged. 3.2.1 When reporting results for related substances, refer to the limits for unknown impurities and the LOD and LOQ limits for known impurities. Do not consider unknown impurities that are below the non-compliance limit. For medicinal products: dosage values for APIs, active and inactive excipients should be expressed as mg and percentage. · Specify numeric values whenever possible instead of writing "compliant". Figures for rounding numerical values for comparison with requirements 3.2.2 If the known impurity is less than the LOD, do not include it in the calculation.
3.4 If the method of analysis or test does not require quantification, the result of the analysis shall be indicated as “compliant” or “non-compliant” on the certificate of analysis in this case. However, the actual observation of the analysis shall be indicated in the worksheet (e.g. less than 50 ppm, the colour intensity of the sample solution is not greater than that of the standard solution `x` or the formation of a specific colour for dissolution or precipitation).