Glossary

Cleaning Validation

What is Cleaning Validation in Pharma?

Cleaning validation is the process of providing documented evidence that the cleaning methods employed consistently control potential carryover of product residues, cleaning agents, and extraneous material into subsequent products to levels below predetermined acceptance limits.

What are the guidelines of cleaning in the pharma industry?

The key guidelines for cleaning validation in the pharmaceutical industry are provided by regulatory bodies such as:

FDA (Food and Drug Administration)
EMA (European Medicines Agency)
PIC/S (Pharmaceutical Inspection Co-operation Scheme)
WHO (World Health Organization)
ISPE (International Society for Pharmaceutical Engineering)

These guidelines outline the requirements and best practices for establishing cleaning procedures, setting acceptance criteria, and documenting the validation process.

What do you understand by MACO?

MACO stands for Maximum Allowable Carryover. It is the maximum amount of residue from a previous product that can be present in the next product without posing a safety risk or affecting product quality. Setting appropriate MACO limits is a critical part of the cleaning validation process.

Is cleaning validation an important task in pharma?

Yes, cleaning validation is an essential task in the pharmaceutical industry for several reasons:

It ensures the safety and purity of drug products by preventing cross-contamination.
It is a regulatory requirement for active pharmaceutical ingredient (API) manufacturing.
It provides internal control and compliance assurance for the manufacturing process.
It demonstrates the effectiveness of cleaning procedures to consistently meet predetermined acceptance criteria.
Proper cleaning validation is crucial to maintain product quality, patient safety, and regulatory compliance in the pharmaceutical industry.