ALCOA+ Principles — The Rules for Every GMP Record¶

What it is¶

ALCOA+ is a nine-attribute framework that defines what a trustworthy GMP record looks like. Every record you create — a batch sheet, a cleaning log, a training entry — must satisfy all nine. The name comes from the first five attributes (ALCOA), with four further attributes added by regulators over time (the "+").

Attribute	One-line rule
Attributable	It is clear who did it and when
Legible	It can be read now and in five years
Contemporaneous	It was recorded at the time, not reconstructed later
Original	It is the first capture of the data, not a copy
Accurate	It is correct, truthful, and complete enough to be useful
Complete	All data is present, including failures and repeated tests
Consistent	Entries follow a logical, chronological sequence
Enduring	The medium will survive the required retention period
Available	The record can be retrieved when needed

Read before: what-is-gmp-documentation (documents vs records).

Why it matters¶

A product that was made correctly but documented badly is treated the same as a product that was made badly. This sounds harsh, but the logic is sound: an auditor cannot go back in time to watch a batch being made. The record is the only evidence of what happened. If the record cannot be trusted, the batch cannot be trusted.

Data integrity — the degree to which records are accurate, complete, and reliable — is one of the most inspected areas in GMP today. Regulators have issued major enforcement actions (import bans, facility shutdowns, consent decrees) against manufacturers whose records failed ALCOA+ standards, even when no product harm was identified. The reason: if records are unreliable in small ways, they may be unreliable in large ways too.

For a small operation just starting out, ALCOA+ violations are almost always unintentional — habits carried over from non-regulated work. Learning these nine rules early prevents the kind of systemic record-keeping failures that are very hard to correct once they are embedded in your team's habits.

What you must do¶

Apply each attribute to every record you create. The rules below are written as concrete instructions, not abstractions.

1. Attributable — sign every entry, every time¶

Every entry in a GMP record must identify who made it and when. Use your signature or initials, the date, and the time where the timing of an activity matters.

Do: Weighed by: J. Oduya | 14 May 2026 | 09:42
Don't: An unsigned entry. An entry signed by a supervisor "on behalf of" the person who did the work. A column left blank because "everyone knows it was me."

Establish a signature specimen list — a controlled document that links each person's initials or signature to their full name and role. Auditors use this to verify entries.

2. Legible — permanent ink, clear writing, always¶

Every entry must be readable today and when the record is retrieved five or ten years from now. Write with permanent ballpoint or rollerball ink. Never use pencil. If your handwriting is difficult to read, print in block capitals.

Do: Clear, printed numerals in black or blue ballpoint ink.
Don't: Pencil (can be erased). Fading felt-tip. Ink that smears when wet. Handwriting that another person cannot decipher without asking you.

3. Contemporaneous — record it as you do it, not afterwards¶

The entry timestamp should reflect when the activity occurred. Fill in the record at the point of activity — at the balance while weighing, at the equipment after cleaning, at the incubator while reading a temperature.

Do: Complete the batch record line by line as each weighing step is performed.
Don't: Weigh all 12 ingredients, then sit down and fill in the batch record from memory at the end of the shift.

The test: if a colleague walked in and asked "what are you doing right now?" and you said "filling in this record for what I did an hour ago," that is a contemporaneous failure.

4. Original — keep the first capture, never discard it¶

The original record is the first place the data was captured. Do not transcribe data onto "neater" paper and throw away the original. If an instrument produces a printout, that printout is the original — attach it to the record, initial it, and date it.

Do: Attach the balance printer tape to the batch record; write the batch number on the tape so it cannot be separated and misfiled.
Don't: Copy weights from a printout onto a form and discard the printout. Use a "rough" sheet during production and copy it onto the "official" form afterwards.

If transcription is unavoidable (e.g., copying from an instrument screen that does not print), note it explicitly: "Transcribed from instrument display by [name] at [time]. Original instrument reading not available." Never present a transcription as if it were an original.

5. Accurate — record what happened, not what should have happened¶

Every entry must reflect reality. Record the actual measured value, not the target. Record the actual time, not when you planned to do something. If a result is out of specification, record it and investigate — do not change it to the "correct" value.

Do: Record a measured weight of 503.2 g even though the target was 500.0 g. Then note: "Outside ±0.5% tolerance — see non-conformance report NC-2026-014."
Don't: Record 500.0 g because "it was close enough" or because you are worried about what the number will look like in an audit.

Inaccuracy — even when the underlying product is fine — is a critical finding because it raises the question: what else was recorded inaccurately?

6. Complete — include everything, especially the inconvenient parts¶

All data generated by an activity must be included in the record. This means:

Every test result, including results that failed and were repeated.
Every instrument reading, even anomalous ones.
Corrections and their reason (see the error correction rule below).

A record with gaps — missing results, blank columns, omitted repeats — is treated as a suspect record.

Do: If a microbial plate gave an anomalous count and was repeated, include both the original result and the repeat, with an explanation of the invalidation reason.
Don't: Include only the passing repeat and file the original result in a drawer "for reference."

7. Consistent — entries must follow a logical sequence¶

Timestamps and sequence of events must make sense. A start time cannot be later than a finish time. Three activities logged at exactly the same time by one person are suspicious. An entry dated before the SOP it was performed under was approved is impossible.

Do: Log activities in the order they were performed, with accurate times.
Don't: Back-fill several entries simultaneously. Enter a production end time before the production start time. Sign a training record for a training session that had not yet occurred.

8. Enduring — use media that will survive the retention period¶

Records must physically survive as long as they are required to be kept (typically 1–5 years after the product's expiry date, depending on the regulation). Paper records must be stored in dry, secure, stable conditions. Electronic records must be backed up and protected against loss.

Do: Store completed batch records in a dedicated filing cabinet in a dry room, away from production moisture and heat.
Don't: Keep records in a humid stockroom, a vehicle, a stack on the production floor, or only on a personal mobile phone.

If you use thermal paper (e.g., some balance printer tapes), photocopy it immediately — thermal prints fade within years. File the photocopy with a note that it is a true copy of a thermal original.

9. Available — retrievable within a reasonable time¶

Records must be accessible when needed: during a regulatory inspection, a complaint investigation, or a product recall. "It's in a box somewhere" does not meet this requirement. "I'll find it by tomorrow" during an active recall is too slow.

Do: File records in a labelled, indexed system. A simple binder index or a spreadsheet register of batch records with their file location is sufficient for a small operation.
Don't: Store records in unsorted boxes, personal drawers, or a shared folder with no naming convention.

Correcting errors on paper records¶

Errors on paper records must be corrected in a specific way:

Draw a single line through the incorrect entry — the original value must still be readable.
Write the correct value next to or above it.
Add your initials, the date, and a brief reason (e.g., "transcription error," "wrong unit").

Never use correction fluid (Tipp-Ex / white-out). Never obliterate an entry so it cannot be read. A corrected record that follows this rule is completely acceptable; a record with obliterated entries suggests something is being hidden.

What "good" looks like¶

A single line from a batch manufacturing record that satisfies all nine attributes:

Step 7 — Add Preservative (Phenoxyethanol) Target: 5.00 g | Actual: 5.02 g Added by: A. Kamau | Time: 11:14 | Date: 14 May 2026 | Signature: [signed] Balance ID: BAL-003 | Cal. due: 2026-09-01

Checking each attribute against this entry:

Attribute	Evidence in the entry
Attributable	Name, signature, date, time present
Legible	Assumed: written clearly in permanent ink
Contemporaneous	Time of entry (11:14) matches production schedule
Original	Written directly onto the batch record at the balance
Accurate	Actual weight (5.02 g) recorded, not the target
Complete	Both target and actual shown; no omissions
Consistent	Time sequence fits the surrounding steps
Enduring	Paper record stored in controlled conditions
Available	Filed in the batch record for lot B-2026-047

A full batch record built on entries like this one gives an auditor complete, trustworthy evidence of exactly what happened during manufacture.

Common mistakes¶

Using correction fluid. This is one of the most common GxP findings in small operations. Replace every bottle of Tipp-Ex in your facility with a single-line correction rule and make sure the whole team understands it.
Pre-signing blank records. Signing forms before the activity has been performed "to save time later" means the signature is not attributable to an actual event. It is also a falsification finding.
Signing for a colleague. Even when you watched every step, you cannot sign for another person's activity. Your signature means you did it or you directly verified it. If both people need to sign, both sign.
Omitting failing results. If a test fails and is repeated, both results must be present. Filing the failure separately "so it doesn't confuse the batch record" is a completeness violation and can be treated as data manipulation.
Informal records. Phone photographs of instrument screens, WhatsApp messages between staff confirming a step was done, sticky-note temperature logs. None of these are GMP records. They are not controlled, not signed, not retained, and not available in a regulated sense.
Backdating. Writing "2026-05-13" on a record that was actually filled in on 2026-05-15 because that is when the activity happened. If you are behind on records, the correct approach is to complete them now with the actual date and note the delay and its reason — not to falsify the date.

Templates & checklists¶

[[alcoa-plus-self-check]] — [to be created] — A per-record checklist to verify that a completed entry satisfies all nine ALCOA+ attributes before filing.