# Calculations Of Residue Limits For Medicinal Product For Equipment .

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Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation 1. Purpose The Purpose of this guideline is to define the minimum requirements for cleaning and validation of cleaning processes for formulated product. It also covers post validation monitoring of the effectiveness of cleaning processes. This guideline provides equations and examples for calculating the Maximum Allowable Residue (MAR), and Residue Acceptability Limits (RAL) for Drug Products and Non-Therapeutics. Examples are provided for determining the acceptable equipment cleaning residue limits for therapeutic drug products (MART and RALT) and for non-therapeutic ingredients (MARN and RALN). For the therapeutic drug products both single product combination (Product A to B) and multiple products combination examples are given. 2 Scope and Applicability This document is applicable to all commercial and investigational formulated products manufactured within a R&D and Operations facilities. It sets standards for cleaning and cleaning validation that suppliers of formulated products should be assessed against. Cleaning for primary packaging operations is also included. This guideline applies to the validation of cleaning procedures for equipment used in manufacture of pharmaceutical products, but excludes Active Pharmaceutical Ingredients (API) and their intermediates. Microbiological aspects of cleaning and determination of effectiveness are not considered in this document. Such activities should be treated on a case-by-case basis with due consideration given to manufacturing operations, area classifications, dosage forms etc. The attached Appendices give equations and example calculations for therapeutic drug product cleaning limits for a solid oral dosage form (tablet), creams/ointment and ophthalmic product. In Case-1 therapeutic example it is included the calculation of Maximum Allowable Residue (MAR) limits using two formulas; dose MART and toxicity MAR. It also includes an example for determining the worst case limit for shared equipment using multiple products. Example for residue limits calculation of CIP 100 detergent, a non-therapeutic ingredient is also given. 3 Definitions 3.1 Hot Spot A surface which is judged to be difficult to clean, or where microbiological growth may be foreseen, such as bends, valves, feed controls, sleeve couplings, bushing and hidden surfaces. 3.2 Limit of Detection The lowest amount of a given substance in a sample that can be detected but not quantified with the selected analysis procedure. 3.3 Limit of Quantification Copyright www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 5 of 31

Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation Copyright www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 12 of 31

Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation Copyright www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 18 of 31

Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation Copyright www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 25 of 31

Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation Copyright www.gmpsop.com. All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 30 of 31

The Purpose of this guideline is to define the minimum requirements for cleaning and validation of cleaning processes for formulated product. It also covers post validation monitoring of the effectiveness of cleaning processes. This guideline provides equations and examples for calculating the Maximum Allowable Residue

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