Glossary

MACO (Maximum Allowable Carryover)

What is MACO?

The maximum amount of residue or contaminant permitted to be carried over from one batch or product to another in a shared equipment or facility ensures that the subsequent product’s quality and safety are not compromised.

In other words, MACO is the maximum acceptable limit of residual material that can be left behind in equipment or facilities after cleaning and sanitation to prevent cross-contamination and ensure the integrity of subsequent products. This is a critical concept in pharmaceutical manufacturing, where the risk of contamination can have serious consequences for product quality and patient safety.

How is MACO relevant in pharma?

Maximum Allowable Carryover (MACO) is relevant in pharma for ensuring:

  • Product Quality and Safety: By setting a maximum carryover limit, MACO ensures that the quality and safety of subsequent products are not compromised by residual contaminants or residues from previous batches.
  • Limiting Risk of Adverse Reactions: By limiting the amount of carryover, MACO reduces the risk of adverse reactions in patients due to contamination or residue from previous products.
  • Regulatory Compliance: MACO helps pharmaceutical companies comply with regulatory requirements, such as FDA guidelines, which emphasize the importance of controlling carryover to ensure product quality and safety.
  • Preventing Cross-Contamination: MACO helps prevent cross-contamination between different products, especially when manufacturing multiple products in the same facility or using shared equipment.

How is MACO relevant in ensuring regulatory compliance?

Here are some ways Maximum Allowable Carryover (MACO) ensures regulatory compliance in pharma:

  • Compliance with FDA Guidelines: MACO ensures compliance with FDA guidelines, such as the FDA’s Guidance for Industry on Cleaning Validation, which emphasizes the importance of controlling carryover to prevent contamination.
  • ICH Q7 and Q9 Compliance: MACO helps pharmaceutical companies comply with International Conference on Harmonisation (ICH) guidelines, including Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and Q9 (Quality Risk Management), which address carryover and contamination risks.
  • EU GMP Compliance: MACO ensures compliance with European Union Good Manufacturing Practice (EU GMP) guidelines, which require pharmaceutical companies to control carryover and prevent contamination.
  • 21 CFR Part 211 Compliance: MACO ensures compliance with 21 CFR Part 211, which outlines the FDA’s current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including requirements for cleaning and sanitation.