Classification Evaluation Approval Of Cleaning Agents - GMP SOP

Efficient and safe cleaning is a crucial prerequisite for the manufacture of drug products or medical devices. The appropriate selection and control of cleaning agents (solvents, detergents and sanitizers) is an essential part of the entire cleaning process.

This Standard Operating Procedure (SOP) provides clear and structured guidance on how to evaluate and classify cleaning agents to ensure there is no interaction with drug products and manufacturing equipment. This Standard Operating Procedure (SOP) contains a 10-page process description with 3 attachments where you can list your cleaning agents. It is ready to use and only needs a small amount site-specific modification before it can be implemented in your operations.

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Description

Table of Content

2. Purpose
3. Scope
4. Cleaning Agents
4.1 Cleaning Agent Classification System
4.2 Cleaning Agent Classes
4.3 Cleaning Agent Types
4.4 Cleaning Agent Usage
5. Procedure
5.1 Evaluation of Cleaning Agents
5.2 Approval of New Cleaning Agents
5.2.1 Manufacturing Manager or above
5.2.2 Quality Assurance
5.2.3 Safety, Industrial Hygiene and Environmental Department
5.3.1 Release and Storage of cleaning agents
6. Distribution
7. Attachments
7.1 Attachment for cleaning agents class I (Table 1)
7.2 Attachment for cleaning agents class II (Table 2)
7.3 Attachment for cleaning agents class III (Table 3)

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SKU Classification Evaluation Approval Of Cleaning Agents - GMP SOP

FDA-EMA

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Delivery item: Word Document
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