ABSTRACT

One might think surely industry has this topic addressed, however, this is not the case.

This technical briefing illustrates recent examples of regulatory non-compliance in cleaning validation, summarizes the subject and details the considerations, early developments (1970s – 1980s), initial concerns, first guidelines, regulatory evolution (1990s), formalization of cleaning validation, competent authorities and industry response, standardization and global adoption (2000s-Present), key concepts and current requirements in cleaning validation.

Cleaning validation is a critical aspect of pharmaceutical manufacturing and other industries where contamination and cross-contamination control is fundamental to patient safety, compliance, industry standards and consumer expectations. Its primary goal is to ensure that cleaning processes effectively remove residues of active ingredients, excipients, cleaning agents and microorganisms, to prevent contamination of subsequent batches and ensure product quality and patient safety is not compromised.

KEYWORDS: Acceptance Criteria, Active Pharmaceutical, Ingredient (API), Analytical Methods, Carry Over Criteria, Cleaning Agents, Cleaning Validation, Compliance, Contamination, Cross-contamination, Detection of Residue, Effective Cleaning Process, EU GMP Annex 1, European Medicines Agency (EMA), Good Manufacturing Practice (GMP), Guidelines, Health Based Exposure Limits (HBELs), High-Performance Liquid Chromatography (HPLC), International Council for Harmonisation (ICH), Legislation, MACO Calculations, Mass Spectrometry, Maximum Acceptable Carryover Limit (MACO), Microorganisms, Multiuse Equipment, Patient Safety, Permitted Daily Exposure, Product Recall, Purity, Quality Assurance, Regulatory Non-Compliance Examples, Residue Limits, Risk Management, Safeguarding, Safety, Sanitise/Sanitize, Sterilise/Sterilize, Toxicological Evaluation, US Food and Drug Administration (FDA), Validation of Cleaning Procedures, Worst Case Product Determinations.

Further related information can be found in the following associated briefs:

1. Airborne particle counting using LSAPC – Technical Briefing (PDF)
2. Cleanroom Classification – Technical Briefing (PDF)
3. Cleanroom Testing – Technical Briefing (PDF)
4. High Efficiency Air Filters – Technical Briefing (PDF)
5. Cleanroom Airflow Visualisation – Technical Briefing (PDF)
6. Liquid and Gas Filtration – Technical Briefing (PDF)