Question 1

How do I determine the number of cleaning processes for equipment?

Accepted Answer

Determine the number of cleaning processes for each piece of equipment. Ideally, a piece of equipment or system will have one process for cleaning, however this will depend on the products being produced and whether the cleanup occurs between batches of the same product (as in a large campaign) or between batches of different products.

Question 2

What is the purpose of the agency's cleaning procedures guide?

Accepted Answer

These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated. This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable).

Question 3

Is there a guide to equipment cleaning for chemical residues?

Accepted Answer

This guide is intended to cover equipment cleaning for chemical residues only. For FDA to require that equipment be clean prior to use is nothing new, the 1963 GMP Regulations (Part 133.4) stated as follows "Equipment *** shall be maintained in a clean and orderly manner ***."

Question 4

What does FDA expect firms to have written procedures for cleaning?

Accepted Answer

The firm had evidence, from TLC tests on the rinse water, of the presence of residues of reaction byproducts and degradants from the previous process. FDA expects firms to have written procedures (SOP's) detailing the cleaning processes used for various pieces of equipment.

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