Free MACO Calculator

The MACO Calculator (Maximum Allowable Carryover) is designed to assist pharmaceutical professionals in calculating cleaning validation limits for pharmaceutical processes in accordance with WHO GMP, PIC/S and ICH Q7 guidelines. Input the last product dose, safety factor, batch size and next product dose to determine the allowable carryover limit.

MACO Calculator
Maximum Allowable Carryover · WHO GMP / PIC/S / ICH Q7
✓ GMP Verified Free Tool
📋
Formula: MACO = (TDDprev × SF × MBSnext) ÷ LDDnext — WHO/PIC/S standard for shared equipment cleaning validation. Enter values for the previous (contaminating) product and the next (recipient) product.
Previous Product
iMaximum daily dose of the previous (contaminating) product per its approved prescribing information.
mg/day
Max daily dose from approved label or CMC data
iWHO default is 0.001 (1/1000) for shared equipment. Use 0.0001 for cytotoxic or high-potency compounds.
factor
WHO default: 0.001 · Cytotoxics: 0.0001
Next Product
iSmallest batch of the next product made in the same equipment. Worst-case scenario for carryover dilution.
mg
Smallest planned batch from batch records
iMaximum daily dose of the next product a patient will receive. Used to assess patient exposure to carryover residue.
mg/day
Max single-patient daily dose from next product label
Acceptance Limit
iOptional. Your site-defined acceptance limit in mg. If entered, shows a GMP compliance status against this limit.
mg
Optional: compare MACO against your validated cleaning limit
Live MACO Estimate
Updates as you type
— mg
Maximum Allowable Carryover (MACO)
mg
📊 GMP Interpretation
Next Steps
    Formula used (substituted values):
    For calculation assistance only. Verify against your site SOP.

    Frequently asked Questions

    What does MACO stand for in cleaning validation?

    The maximum amount of residue from a previous product that is allowed to be left on shared equipment without risk to patients and without compromising the product quality is called Maximum Allowable Carryover (MACO). It is one of the important criteria in cleaning validation for pharmaceuticals.

    How is MACO calculated?

    The WHO GMP formula is: MACO = (TDD Previous Product × Safety Factor × Minimum Batch Size of Next Product) ÷ Largest Daily Dose of Next Product
    The Safety Factor varies depending on the product, the batch size of the next product, and your daily dose.The Safety Factor will depend on the product, minimum batch size of next product and maximum daily dose of next product.

    Q3: What is the safety factor used in MACO?

    The WHO GMP guidance recommends a default value of 0.001 (1/1000). Very potent, toxic or sensitizing compounds could be subject to more stringent factors, depending on the risk assessment.

    FAQ 4: What are the regulations that need MACO calculations?

    Generally, MACOs are cited in the following:
    WHO GMP Guidelines
    PIC/S GMP Guide
    ICH Q7
    EU GMP Annex 15
    The FDA guidelines document for Cleaning Validation.

    References:

    The MACO mathematical calculations used in this calculator are based on WHO GMP guidance, PIC/S recommendations, ICH Q7, EU GMP Annex 15, FDA Cleaning Validation Guidance, APIC Cleaning Validation Guidance, and PDA Technical Report No. 29. The users should check compliance for criteria according to their own site-specific cleaning validation program, HBEL/PDE assessments and applicable regulation.

    WHO GMP Cleaning Validation Guidelines
    PIC/S Cleaning Validation Guidance
    ICH Q7 GMP: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
    Section 12 – Validation
    EU GMP Annex 15
    FDA Validation of Cleaning Processes
    APIC Cleaning Validation Guidance
    PDA Technical Report No. 29

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