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ISO 22716 GMP audit checklist for cosmetics

ISO 22716 is the international guideline for good manufacturing practice (GMP) in cosmetics. It sets how a plant controls people, premises, equipment, materials, production, testing and records, so each batch is made the way it should be. An ISO 22716 GMP audit checklist turns those sections into questions an internal auditor can answer. This one has 25 checks in five groups. Two are a floor walk, done while a batch is made or filled: people, premises and equipment (sections 3 to 5), and materials, production and finished products (sections 6 to 8). Three are system checks with the quality team: the lab and out-of-specification product (9 and 10), waste, subcontracting, deviations, complaints and recalls (11 to 14), and change control, internal audit and documentation (15 to 17). Each check is graded OK, Minor, Major, Critical or N/A, with a findings log and a worked audit of a filling line. In the US, MoCRA gave FDA authority to set GMP rules for cosmetic facilities; this checklist is built on ISO 22716, not on an FDA rule. It supports internal audits beside your quality system and does not make a plant compliant or certified.

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Page 1 of the ISO 22716 GMP audit checklistAudit details, the five grades, and floor walk checks on people, premises and equipment, each with its section, a grade and a finding column.
25 checks by ISO 22716 sectionFloor walk and system checksFive grades with days to fixFindings logScore by groupWorked filling line auditPDF, Excel and Word
Filled-in ISO 22716 GMP audit checklist for cosmetics: an internal audit of a lotion filling line
The same sheet filled in with the worked example (page 6 of the PDF, illustrative numbers). Open full size (opens the picture in a new tab)

When to use it

When to use an ISO 22716 audit checklist

  • For the internal audits ISO 22716 section 16 asks for, one area or group of sections at a time.
  • Before a certification audit, a retailer or brand-owner audit, or an FDA visit, to find gaps while there is time.
  • After an out-of-specification batch, a complaint trend or a mix-up on a filling line, to check the system behind it.
  • When a contract manufacturer onboards a new customer, to show where its GMP stands.

How to fill it in

  1. 1

    Plan the audit

    Pick the area and sections from your internal audit program, and an auditor who does not work there. Mark sections that do not apply N/A, with the reason.

  2. 2

    Walk while a batch runs

    The floor walk only works with production on: hygiene at the line, status labels on bulk, the start-up check for the run, in-process checks being done.

  3. 3

    Then the system checks

    With the quality team, sample the lab records, the last out-of-specification investigation, deviations, complaints, change records and documents.

  4. 4

    Grade with evidence

    Grade each check OK, Minor, Major, Critical or N/A and write the evidence: batch numbers, tank numbers, record pages.

  5. 5

    Act on product questions first

    Bulk past its hold time, unlabeled tanks or released product with a doubt go to quality the same day, before the audit moves on.

  6. 6

    Log and follow up

    Log each finding with an owner and a due date, and check the fix before closing it. Trend the Minors by line: they show where the routine is slipping.

ISO 22716 sections and where to check them

Floor walk or system check: sections 3 to 17

Where this checklist checks each section of ISO 22716, named, not quoted.

  • 3 Personnel, 4 Premises, 5 Equipment

    Where
    Floor walk
    What you look at
    Hygiene and clothing, flow and separation, cleaning status labels, calibrated instruments
  • 6 Raw and packaging materials, 7 Production, 8 Finished products

    Where
    Floor walk
    What you look at
    Release status, water monitoring, start-up checks, bulk labels and hold times, in-process checks, storage
  • 9 QC laboratory, 10 Out-of-specification product

    Where
    System
    What you look at
    Test records, retained samples, release decisions, the last out-of-specification investigation
  • 11 Wastes, 12 Subcontracting, 13 Deviations, 14 Complaints and recalls

    Where
    System
    What you look at
    Waste handling, contracts, the deviation log, complaint files, the last mock recall
  • 15 Change control, 16 Internal audit, 17 Documentation

    Where
    System
    What you look at
    Change records, the audit plan and its actions, document versions and how records are corrected

The 25 checks

What to check, by section of ISO 22716

The first two groups are a floor walk, done while a batch runs; the last three are system checks with the quality team. Each check names its section, asks one question in plain words and says what to look at, and is graded OK, Minor, Major, Critical or N/A.

Floor walk: people, premises and equipment

ISO 22716 sections 3, 4 and 5

  1. 1Sec. 3: Are people trained for their tasks and in GMP, with records, and do they follow hygiene and clothing rules in production areas? Look at: two operators' training records; hair covers, gloves and hand washing at the line.
  2. 2Sec. 3: Do visitors and contractors follow the same hygiene rules and stay with an escort in production areas? Look at: the visitor log; anyone on the floor without the right clothing.
  3. 3Sec. 4: Are premises laid out so materials and people flow without mix-ups, with separate or defined areas for storage, production, QC and washing? Look at: floor markings; a pallet of raw material standing in a filling area.
  4. 4Sec. 4: Are floors, walls, ceilings and drains clean and in good repair, with cleaning and pest control done to plan? Look at: corners, overhead pipes above open tanks, drains, pest device records.
  5. 5Sec. 5: Is equipment suited to its use, cleaned and sanitized to written procedures, and labeled with its clean or dirty status? Look at: status labels on tanks and fillers; the cleaning record for the last change.
  6. 6Sec. 5: Are measuring instruments (balances, thermometers, fill weight scales) calibrated and labeled? Look at: calibration labels; the balance check log.

Floor walk: materials, production and finished products

ISO 22716 sections 6, 7 and 8

  1. 7Sec. 6: Are raw and packaging materials received against written specifications, sampled, and held until released? Look at: status labels in the warehouse; one lot's release record.
  2. 8Sec. 6: Is water (purified or treated) produced and monitored to its specification, and are results reviewed? Look at: water test results and the trend.
  3. 9Sec. 7: Before each manufacturing or packaging run, are start-up checks done, the line cleared of the last product and its components, and recorded? Look at: the start-up check or line clearance record for the run on now.
  4. 10Sec. 7: Is each bulk batch made to the formula and written instructions, with weighings checked and recorded at the time? Look at: the batch record and one weighing in progress.
  5. 11Sec. 7: Are bulk tanks and containers labeled with product, batch and status, and used within their set hold time? Look at: labels on bulk; the date made against the hold time.
  6. 12Sec. 7: Are in-process checks (fill weight, torque, label position, coding) done at the set frequency and recorded? Look at: the in-process check sheet at the filler.
  7. 13Sec. 8: Is finished product held until released, stored to protect it, and shipped so that oldest released stock goes first? Look at: warehouse status labels; storage conditions.

System: quality control and out-of-specification product

ISO 22716 sections 9 and 10

  1. 14Sec. 9: Does the QC lab test against written specifications and methods, keep reagents and reference samples identified, and keep retained samples of each finished batch? Look at: one test record; the retained sample store.
  2. 15Sec. 9: Are results reviewed and signed before release, with a clear release decision for each batch? Look at: the release record of two batches.
  3. 16Sec. 10: Is out-of-specification product investigated, with the decision (release, rework or reject) taken by authorized people and recorded? Look at: the last out-of-specification investigation.

System: waste, subcontracting, deviations, complaints and recalls

ISO 22716 sections 11 to 14

  1. 17Sec. 11: Is waste collected, stored and removed so it cannot reach product, with destroyed printed packaging recorded? Look at: waste containers in production; the destruction record.
  2. 18Sec. 12: Is there a written contract with each subcontractor for manufacturing, packing or testing, setting who does what in GMP? Look at: one contract and the last check of that subcontractor.
  3. 19Sec. 13: Are deviations from written instructions recorded, justified and assessed for their effect on quality? Look at: the deviation log; two recent entries.
  4. 20Sec. 14: Are complaints recorded, investigated and followed up, with trends reviewed? Look at: the complaint file; two recent complaints.
  5. 21Sec. 14: Is there a recall procedure that can trace a batch to its customers, and has it been tested? Look at: the procedure and the last mock recall.

System: change control, internal audit and documentation

ISO 22716 sections 15, 16 and 17

  1. 22Sec. 15: Are changes that could affect product quality approved before they are made, with the reasons and checks recorded? Look at: change records from the last 6 months.
  2. 23Sec. 16: Are internal audits planned and done by competent people, with findings followed up to closure? Look at: the audit plan and the last audit's actions.
  3. 24Sec. 17: Are documents (specifications, formulas, instructions, procedures, records) approved, at the current version where they are used, and are old versions withdrawn? Look at: two documents at the line against the master list.
  4. 25Sec. 17: Are records filled in at the time, legible, corrected so the original stays readable, and kept for the set period? Look at: two pages of a batch record.

A filled-in example

Illustrative, not a benchmark

An example: an internal audit of filling line 3 at a made-up lotion and shampoo plant, running a body lotion, plus the system checks with the quality team (illustrative, the same as the Excel example sheet and page 6 of the PDF). The plant uses no subcontractors.

The example audit, graded

  • OK: 20 checks
  • Minor: 3 checks
  • Major: 1 check
  • N/A: 1 check

Score = OK ÷ (OK + Minor + Major + Critical)

25 checks, 1 N/A left out

  1. 20 ÷ 24= 83.3%
Score83.3%

25 checks: 20 OK, 3 minor, 1 major, 0 critical and 1 not applicable. Score 20 of 24 graded, 83.3 percent.

Illustrative. The N/A check is subcontracting (section 12): the plant uses none. The major was a bulk tank with no batch or status, past its hold time.
  • 25 checks: 1 N/A (section 12, no subcontractors), so 24 graded.
  • 1 Major (section 7): bulk tank T3 labeled with the product but not the batch or status, holding lotion made 9 days earlier against a 7-day hold time. Tank put on hold until quality tested the bulk.
  • 3 Minor: filler 3's last cleaning record with no verifier signature (section 5); two cases of released caps with torn status labels (section 6); a batch record entry overwritten so the first value cannot be read (section 17).
  • 20 OK, no Critical.

Score = 20 ÷ 24 = 83.3%. The tank is the finding to chase: bulk with no batch or status, past its hold time. The three Minors are all labels and signatures, the everyday paperwork that makes a batch traceable.

Common mistakes

  • Auditing with the line stopped

    A floor walk on a quiet day sees clean equipment and tidy labels. Walk while a batch is being made or filled.

  • Skipping the system sections

    Deviations, complaints, change control and documentation are where repeat problems show up. A floor walk alone misses them.

  • No hold time on bulk

    Bulk waiting to be filled needs a batch, a status and a use-by date on its label. Without them, nobody can say whether it is still fit to fill.

  • Correcting records by overwriting

    A correction must leave the first value readable, with who changed it, when and why. An overwrite looks like a hidden error even when it is not.

  • Assuming ISO 22716 covers OTC products

    In the US, products such as sunscreen or anti-dandruff shampoo are also OTC drugs and fall under drug GMP. Check which rules apply to each product.

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FAQ

ISO 22716 GMP audit checklist for cosmetics: common questions

  1. The international guideline for good manufacturing practice in cosmetics. It covers personnel, premises, equipment, raw and packaging materials, production, finished products, the QC lab, out-of-specification product, waste, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation.

  2. Whether the plant does what each section asks, in practice. On the floor: hygiene, clean equipment, released materials, start-up checks, labeled bulk and in-process checks. In the system: lab records, out-of-specification decisions, deviations, complaints, recalls, change control, audits and documents.

  3. Not by name. MoCRA, the Modernization of Cosmetics Regulation Act of 2022, gave FDA authority to set GMP rules for cosmetic facilities; check FDA's cosmetics pages for where that rule stands. Many plants use ISO 22716 because customers ask for it and EU rules expect GMP.

  4. Drug GMP (21 CFR 210 and 211 in the US) is a binding rule with a quality unit, validated processes, label reconciliation and lab controls for every batch. ISO 22716 covers similar ground with lighter, more general requirements. Cosmetics that are also OTC drugs, such as sunscreen, follow drug GMP.

  5. As often as your internal audit program sets, by risk. A common pattern is to cover every section at least once a year, and the filling and packing lines, where mix-ups and labeling errors can happen, more often.

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