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GMP audit checklist for drug manufacturing

A GMP audit checks how a drug plant follows good manufacturing practice. It covers the people, buildings, equipment, materials, production, packaging, labs and records that keep each batch right. A GMP audit checklist is the auditor's list of what to check and where to find the evidence. This one is built for a self-inspection (internal audit) of a drug manufacturing plant. It has 42 checks in the order of the subparts of 21 CFR 211, FDA's drug GMP rule: organization and personnel, buildings and facilities, equipment, components and containers, production and process controls, packaging and labeling, holding and distribution, laboratory controls, records and reports, and returned products. Each check names its section, the matching chapter of EU GMP Part I, and whether you answer it on the floor walk (F) or from records (R). Findings are graded critical, major or minor, with N/A for checks outside the audit's scope. The PDF and Excel file include a findings log and a worked self-inspection of a blister packaging line. The questions are in plain words, not quoted from the rule. It supports internal audits beside your quality system; it is not an FDA inspection and does not make a plant compliant. Food plants follow a different rule, covered by the food plant GMP checklist.

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Page 1 of the GMP audit checklistAudit details, the five grades, and the first checks in 21 CFR 211 order with the section, the EU GMP chapter, floor or records, a grade and a finding column.
42 checks in 21 CFR 211 order21 CFR section for eachEU GMP chapter columnFloor walk or recordsCritical, major, minor gradesFindings logScore by subpartWorked packaging line auditPDF, Excel and Word
Filled-in GMP audit checklist for drug manufacturing: a self-inspection of a blister packaging line
The same sheet filled in with the worked example (page 7 of the PDF, illustrative numbers). Open full size (opens the picture in a new tab)

When to use it

When to use a GMP audit checklist

  • For the self-inspections in your audit program, one area or system at a time, so every part of the plant is covered over the year.
  • Before a regulatory inspection or a customer audit, to find the gaps while there is time to close them.
  • After a run of deviations, a recall or a complaint trend in one area, to see whether the system behind it is working.
  • To train new internal auditors: each check shows where the evidence lives and whether to look on the floor or in the records.

How to fill it in

  1. 1

    Set the scope and mark what is out

    Pick the area and the subparts from your self-inspection program. Mark the checks outside this audit's scope N/A before you start, with the reason, so the score is honest.

  2. 2

    Pick auditors who do not work there

    An auditor from another area sees what the area has stopped noticing. Write their names on the sheet, and swap areas between audits.

  3. 3

    Walk the floor first

    The F checks are seen while work is going on: gowning, status labels, line clearance, how the batch record is being filled in. Watch before you read.

  4. 4

    Then sample the records yourself

    The R checks come from records you choose: pick the batch, the equipment log and the deviation yourself rather than taking the ones the area hands you.

  5. 5

    Grade, and act on a Critical at once

    Grade each check OK, Minor, Major, Critical or N/A and write the evidence. A Critical means stop, hold the product and tell the quality unit before going on.

  6. 6

    Agree, log and follow up

    Agree the facts with the area owner, log each finding with an owner and a due date, and send anything that needs a root cause into your CAPA system. Close it only when the fix has been checked.

How findings are graded

Critical, major, minor: what each grade means in a GMP audit

The grades this template uses, with the days to fix it sets as example settings. Your own procedure decides the grades and the times; change them to match it.

  • Critical

    When to use it
    Product is affected or about to be, or a record is false.
    Example
    Labels from the last batch found on the line after it was released, with product running.
    What happens next
    Stop and hold the product the same day, tell the quality unit, investigate before release.

  • Major

    When to use it
    A miss that could affect product, or shows a system is not working, or several minors on one requirement.
    Example
    In-process checks filled in before the time they record.
    What happens next
    Correct now, find the cause, fix within 15 days (example setting), check the fix worked.

  • Minor

    When to use it
    An isolated miss; product is not at risk and the system still works.
    Example
    One cleaning log entry missing the checker's initials.
    What happens next
    Correct, look for a pattern, fix within 30 days (example setting).

  • N/A

    When to use it
    The check does not apply, or is outside this audit's scope.
    Example
    The lab, when the audit covers only packaging.
    What happens next
    Write why. Left out of the score.

The 42 checks

What to check, by subpart of 21 CFR 211

Each check starts with its 21 CFR section and the matching EU GMP chapter, asks one question in plain words and says what to look at. On the sheet each one is marked F (floor walk) or R (records) and graded OK, Minor, Major, Critical or N/A. The questions paraphrase the rule; read the section itself when a finding is disputed.

Subpart B: organization and personnel

211.22 to 211.34; EU GMP chapters 1 and 2

  1. 1211.22(a); EU Ch. 1: Does the quality unit have, and use, the authority to approve or reject materials, labeling and product and to review production records? Look at: one recent rejection; who signed the last three batch releases.
  2. 2211.22(d); EU Ch. 1: Are the quality unit's responsibilities and procedures written down and followed? Look at: the QA procedure list; one procedure against what the team does today.
  3. 3211.25(a); EU Ch. 2: Is each person trained in the job they do and in GMP, on a continuing basis, with records? Look at: training records of three people on the floor against the tasks they are doing.
  4. 4211.25(c); EU Ch. 2: Are there enough qualified people to run and supervise each operation? Look at: the shift roster against the line's minimum crew; open roles and overtime.
  5. 5211.28(a), (c); EU Ch. 2: Do people wear the clothing the operation calls for and keep out of limited-access areas they are not cleared for? Look at: gowns and hair covers at the line; the access log of one restricted room.
  6. 6211.28(d); EU Ch. 2: Do people report an illness or open wound that could affect the product, and are they kept away from it? Look at: ask two operators what they would report, and to whom.

Subpart C: buildings and facilities

211.42 to 211.58; EU GMP chapter 3

  1. 7211.42(c); EU Ch. 3: Are there separate or defined areas, or other controls, for quarantine, rejects, released stock, production, packaging and the lab, so nothing gets mixed up? Look at: floor markings and signs; any pallet in the wrong zone.
  2. 8211.46; EU Ch. 3: Are air pressure, dust, humidity and temperature controlled where the product needs it, with records? Look at: room monitoring records; dust extraction at dispensing.
  3. 9211.56; EU Ch. 3: Are buildings clean and free of pests, with written sanitation procedures followed? Look at: corners, drains and ceilings; pest device records.
  4. 10211.58; EU Ch. 3: Are buildings kept in good repair? Look at: damaged walls, floors or ceilings in product areas; open work requests for them.
  5. 11211.44, 211.52; EU Ch. 3: Are lighting, hand-wash and toilet facilities adequate and clean? Look at: the light at inspection points; hand-wash stations stocked and working.

Subparts D, F and J: equipment

211.63 to 211.72 (D), 211.105 (F) and 211.182 (J); EU GMP chapters 3, 4 and 5

  1. 12211.63; EU Ch. 3: Is equipment of a suitable design, size and location for its use and for cleaning? Look at: one machine that is hard to clean; its product contact parts.
  2. 13211.67; EU Ch. 3: Is equipment cleaned and maintained on schedule under written procedures, checked clean right before use, with the last batch's identification removed? Look at: the cleaning procedure, the status label, a machine just cleaned.
  3. 14211.182; EU Ch. 4: Does each major piece of equipment have a log of cleaning, maintenance and use, in date order, signed by the person who did the work and the person who checked it? Look at: two equipment logs against the batch records that used them.
  4. 15211.68; EU Ch. 3: Are automatic and computerized equipment calibrated, checked and controlled, with changes to recipes and setpoints limited to authorized people? Look at: calibration records; who can change a recipe or setpoint.
  5. 16211.105; EU Ch. 5: Are lines, vessels and major equipment labeled with what is in them and the batch, and is each equipment ID recorded in the batch record? Look at: labels on vessels and lines in use; the batch record's equipment list.

Subpart E: components, containers and closures

211.80 to 211.94; EU GMP chapter 5

  1. 17211.80, 211.82; EU Ch. 5: Are incoming components, containers and closures received against written procedures, given a lot code and held in quarantine until released? Look at: receiving records; quarantine labels in the warehouse.
  2. 18211.84; EU Ch. 5: Is each lot sampled, tested or examined, then approved or rejected before use? Look at: the release status of three lots on the floor and their test records.
  3. 19211.86; EU Ch. 5: Are approved lots used oldest approved first, and is nothing used that has not been released? Look at: material at the line against its release status in the stock system.
  4. 20211.89; EU Ch. 5: Are rejected materials identified and held under a system that stops their use? Look at: the reject cage and its log.

Subpart F: production and process controls

211.100 to 211.115; EU GMP chapters 1, 4 and 5

  1. 21211.100(a); EU Ch. 4: Are there written production and process control procedures, approved by the quality unit, for the product running? Look at: the master batch record and the SOPs at the line.
  2. 22211.100(b); EU Ch. 1: Are procedures followed and recorded at the time of the work, and is every deviation recorded and justified? Look at: the batch record on the line now; entries made at the step, or before or after it.
  3. 23211.101; EU Ch. 5: Are components weighed or measured as the batch formula says, with a second person or system checking each addition? Look at: the dispensing record; one weighing in progress.
  4. 24211.103; EU Ch. 5: Is actual yield worked out and compared with theoretical yield at the steps the master record sets? Look at: the yield calculation and its limits on a recent batch record.
  5. 25211.110; EU Ch. 5: Are in-process samples taken and tested as written, with results inside limits before the batch moves on? Look at: in-process check sheets and their limits.
  6. 26211.111; EU Ch. 5: Where time limits for a phase of production are set, are they met and recorded? Look at: hold times in the batch record.
  7. 27211.113; EU Ch. 5: Are there procedures to prevent microbial contamination, and for sterile products are aseptic and sterilization processes validated? Look at: the procedures; the last media fill or sterilization validation report where it applies.

Subpart G: packaging and labeling control

211.122 to 211.137; EU GMP chapter 5

  1. 28211.122; EU Ch. 5: Are labels and packaging materials examined on receipt, stored apart by product and strength, and is access to the label store limited? Look at: the label store; who holds the key or badge access.
  2. 29211.125; EU Ch. 5: Is label issue controlled, and are issued, used and returned quantities reconciled, with discrepancies outside preset limits investigated? Look at: the reconciliation on the last three packaging batch records.
  3. 30211.130(a); EU Ch. 5: Is each packaging line separated, physically or by space, from operations on other products? Look at: screens or distance between lines running different products.
  4. 31211.130(e); EU Ch. 5: Is the packaging line inspected immediately before use, and is the result recorded in the batch record? Look at: the line clearance record for the batch running; walk the line yourself.
  5. 32211.134, 211.137; EU Ch. 5: Are finished packs inspected for correct labeling during finishing, and does each pack carry an expiry date? Look at: in-line checks; one finished pack.

Subpart H: holding and distribution

211.142 and 211.150; EU GMP chapter 5

  1. 33211.142; EU Ch. 5: Is finished product held in quarantine until the quality unit releases it, and stored under the right conditions? Look at: warehouse status; temperature records.
  2. 34211.150; EU Ch. 5: Is the oldest approved stock shipped first, with any exception justified, and can each lot be traced to its customers for a recall? Look at: dispatch records for one lot.

Subparts I and J: laboratory controls

211.160 to 211.176 (I) and 211.192 (J) for out-of-specification investigations; EU GMP chapter 6

  1. 35211.160; EU Ch. 6: Are specifications, sampling plans and test methods written, approved by the quality unit and followed, with instruments calibrated? Look at: one test in progress; calibration labels in the lab.
  2. 36211.165, 211.192; EU Ch. 6: Is each batch tested against its specification before release, and is every out-of-specification result investigated? Look at: the last OOS investigation from start to close.
  3. 37211.166, 211.170; EU Ch. 6: Is there a written stability program, and are reserve samples kept and examined? Look at: the stability schedule; the reserve sample store and its log.

Subpart J: records and reports

211.180 to 211.198; EU GMP chapters 1, 4 and 8

  1. 38211.188; EU Ch. 4: Does each batch record show every significant step, with dates, equipment, lots, weights, in-process results, labeling, yields and who did and who checked each step? Look at: one completed batch record, step by step.
  2. 39211.192; EU Ch. 1: Does the quality unit review every batch record before release, and investigate unexplained discrepancies, including other batches that may be affected? Look at: the review checklist; one discrepancy and how far its investigation reached.
  3. 40211.180(e); EU Ch. 1: Are product quality records reviewed at least once a year to decide whether specifications or procedures need to change? Look at: the last annual product review for one product.
  4. 41211.198; EU Ch. 8: Are complaints handled under a written procedure, reviewed by the quality unit and investigated where a specification may not have been met? Look at: the complaint file; two recent complaints.

Subpart K: returned and salvaged products

211.204 and 211.208; EU GMP chapter 5

  1. 42211.204; EU Ch. 5: Are returned products identified, held and evaluated before they are reprocessed or destroyed, with records? Look at: the returns area and its log.

A filled-in example

Illustrative, not a benchmark

An example: a self-inspection of blister packaging line 2 in a made-up oral solid dose plant, during batch BL2-0418, plus that batch's records and the line's logs (illustrative, the same as the Excel example sheet and page 7 of the PDF).

The example self-inspection, graded

  • OK: 23 checks
  • Minor: 3 checks
  • Major: 3 checks
  • N/A: 13 checks

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

42 checks, 13 N/A left out

  1. 23 ÷ 29= 79.3%
Score79.3%

42 checks: 23 OK, 3 minor, 3 major, 0 critical and 13 not applicable. Score 23 of 29 graded, 79.3 percent.

Illustrative. The 13 N/A checks are areas audited on other dates; they are left out of the score.

Floor walk checks against records checks

  1. Floor walk checks (F), gradedLowest12 of 17 OK
  2. Records checks (R), graded11 of 12 OK

Of the graded checks, floor walk checks: 12 of 17 OK. Records checks: 11 of 12 OK.

Illustrative. Five of the six findings were seen at the line while it ran; only the missing initials in the cleaning log came from the records. That is why the floor walk goes first.
  • 42 checks: 13 N/A because receiving, the warehouse, the lab, complaints and returns are audited on other dates and a packaging line does no dispensing. 29 graded. Overall, 23 checks are floor walk checks and 19 are records checks.
  • 3 Major: in-process entries already filled in for 14:00 when the audit reached the line at 13:35 (211.100(b)); line clearance verified by QA 40 minutes after the line started (211.130(e)); a cracked ceiling tile over the tablet feeder with open product below (211.58).
  • 3 Minor: a cleaning log entry with no checker's initials (211.182); a bulk tablet container with no status label (211.105); a wristwatch under a gown sleeve (211.28).
  • No Critical. The output made before the late clearance signature was held and reviewed by QA before release.

Score = 23 ÷ 29 = 79.3%. Two of the three Majors share one cause: the line starts before its paperwork is done. The lasting fix is a start lock until both clearance signatures are in.

Common mistakes

  • Auditing only the paperwork

    A GMP audit done at a desk finds missing signatures and misses the wedged door, the unlabeled container and the pre-filled entry. Walk the floor first.

  • Letting the area pick the samples

    Records handed over by the area are the good ones. Choose the batch, the log and the deviation yourself.

  • Grading a data integrity problem as Minor

    An entry made before the work it records is not a small paperwork slip. Grade it at least Major and look for how often it happens.

  • Using the food GMP checklist in a drug plant

    Food plants follow 21 CFR 117; drug plants follow 21 CFR 210 and 211. The topics overlap, but the requirements, records and quality unit role are different.

  • Closing findings when the action is done

    Close a finding when someone has checked the fix works, not when the task is ticked. Repeat findings at the next audit are the sign it was closed too early.

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FAQ

GMP audit checklist for drug manufacturing: common questions

  1. A GMP audit checks how a plant follows good manufacturing practice: people, buildings, equipment, materials, production, packaging, labs and records. It can be an internal self-inspection, a customer or supplier audit, or a regulator's inspection. This checklist is for the internal one, using the subparts of 21 CFR 211.

  2. First party: your own self-inspection (internal audit). Second party: a customer auditing you, or you auditing a supplier. Third party: a certification or contract audit by an outside body. A regulator's inspection, such as by FDA, is a separate thing again, and is not an audit you choose to run.

  3. As often as your self-inspection program says, set by risk. EU GMP chapter 9 expects a program of self-inspections; a common pattern is to cover every area and system at least once a year, more often for packaging, sterile areas or areas with repeat findings.

  4. Critical: product is affected or about to be, or a record is false; act the same day. Major: a miss that could affect product or shows a system is not working. Minor: an isolated miss with no product risk. Your procedure sets the exact definitions and response times.

  5. No. Drug plants follow 21 CFR 210 and 211, with a quality unit, batch records, label reconciliation and lab controls. Food plants follow 21 CFR 117, which covers hygiene, pests, water and allergens. Use the food plant GMP checklist for a food plant.

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