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October 2000 In the pharmaceutical industry, Good Manufacturing Practices (GMPs) require that the cleaning of drug manufacturing equipment be validated.1 Many different validation techniques can demonstrate that the manufacturing equipment is cleaned and essentially free from residual active drug substances and all cleaning agents.Common analytical techniques in the validation process include HPLC, spectrophotometry (UV/Vis), and TOC.They are essential to accurately determine amounts of residual API or formulation component in comparison to the acceptable residue limit (ARL) for a given cleaning process or equipment train (1).The residue assays are validated for the following parameters: linearity, precision, sensitivity, specificity, detection limit (LOD), quantitation limit (LOQ), and recovery.This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations.If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.Submitted: October 12, 2015 Accepted: December 2, 2015.

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This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.

This document on Cleaning Validation is intended to address special considerations and issues pertaining to validation of cleaning procedures for equipment used in the manufacture of pharmaceutical products, radiopharmaceuticals, and biological drugs.

The document is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures.

From an analytical standpoint, recovery is from the cleaning test sample (i.e., the swab).

From the cleaning program standpoint, the concern is the recovery of the residue from the manufacturing equipment.

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