What are the good documentation practice rules for handwritten GMP entries: date format, late entries, blank fields and ink?

1The rule card.

Each entry is shown right and wrong, with its rule. The examples assume a procedure that sets dd/mm/yyyy dates and the 24-hour clock; the operators are invented.

For US citations, FDA maps ALCOA to Part 211: attributable to 211.101(d), 211.122, 211.186 and 211.188(b)(11); legible to 211.180(e); contemporaneous to 211.100(b) and 211.160(a).⁵ Corrections have their own rules and examples in how to correct a batch record.

2Late entries: what to write, and when not to.

Part 211 and EU Chapter 4 require records made at the time, and Part 211 requires any deviation from written procedures to be “recorded and justified”.⁴² What you may still write depends on whether the value survives anywhere but your memory.

FDA is plain about the notepad: “It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook.”⁵ PIC/S lists “using scraps of paper to record info for later transcription” as an example of a major deficiency.¹ When you investigate, check first whether the form was at hand where the work was done, as PIC/S inspectors do.¹

3What inspectors check on a handwritten record.

PIC/S PI 041-1 lists what inspectors check on paper records. Run the same checks on a sample of batch records and logbooks before an inspection:

• Each issued form has a unique number in an issue register and is reconciled after use (8.4).¹ FDA: numbered sets of blank forms “should be reconciled upon completion of all issued forms”, and a replaced form is kept with the reason.⁵
• Forms are at the point of use (8.6).¹
• All pages present and numbered; added pages counted on the main page (8.4, 8.6).¹
• Handwriting consistent for the same person (8.6).¹
• Key entries are signed and dated as the steps happen, “not just signed at the end of the page and/or process” (8.6).¹
• No pencil under the ink, no erasable ink, and true copies of thermal printouts (8.6).¹
• No ditto marks, “unknown symbols or abbreviations” or “unexplained symbols or entries” (8.6, 8.7).¹
• Signature and initials logs controlled and current (8.6).¹
• Corrections leave the original readable; changes to critical data have a reason and evidence (8.7).¹

Two recent FDA warning letters cite entries signed before the work was done, and one also cites backdating.

Five blank preventative maintenance documents were discovered during the inspection that had been pre-signed and dated to January 9, 2025, in the “Performed by” section. Additionally, your lab manager was observed on August 14, 2025 signing and backdating spectrometry analysis reconciliation records to March 6, 2025.

Tentamus India Private Limited, warning letter 320-26-47, 3 March 2026, under 211.160(a).⁶

For example, the batch record for batch (b)(4), manufactured in December 2024, approximately 6 months before the inspection, did not contain complete information including the full results of in-process testing, and shows multiple instances where initials and dates were pre-filled without documentation of performance, or evidence of performance.

LiquidCapsule Manufacturing, LLC, warning letter 320-26-31, 19 December 2025, under 211.188.⁸

4What the rules leave to your procedure.

None of the EU, UK, US or PIC/S texts cited here sets a clock format or an ink colour, says “N/A” or defines a late entry. They require entries that are legible, unambiguous, contemporaneous and attributable, and leave the format to the site. PIC/S expects GDP procedures to specify “data entry formats” and how operators are identified,¹ and the draft Chapter 4 lists date formats among the things to standardise.⁹ India’s pharmacopoeia commission is an exception: its non-mandatory GD-08 of 2021 asks for indelible ink or a blue ballpoint, prefers the 24-hour clock as HH:MM and has “NA” or “N/A” written in a field that does not apply.⁷ Write these choices down:

1. The date format, and whether months may be written as letters.
2. The clock: 24-hour removes the am and pm question. On multi-site records, the time zone.³
3. How to void a field, a line, a part-page and a blank page, and whether “N/A” is written with the initials and date. India’s GD-08 asks for “a single slanting line from start to end with a signature and date and the reason for the page being blank”.⁷
4. How to write a late entry, and when it goes to a deviation. None of the texts cited here sets a time limit for one: a same-shift or 24-hour limit is the site’s choice.
5. Which pens are allowed, and that pencil, erasable ink and inking over pencil are not.¹
6. When a scribe may be used, in an approved procedure that names the activities.¹³
7. Any correction codes or abbreviations, each defined, so none reads as an unknown symbol.¹

Three draft changes bear on this list. The July 2025 draft Chapter 4 would have each signatory “sign with date and time” (4.65), so a procedure written now should say how a time goes beside each signature. It would require records to show “when the task was performed” (4.59), so a late entry must give the time of the event as well as the time it was written. And an alteration would be signed “by the individual who made the change” (4.60), not just signed.⁹ The consultation ran from 7 July to 7 October 2025,¹⁰ and the Commission’s Volume 4 page still lists the January 2011 chapter.¹¹

5Signature log template.

EU GMP Chapter 4 already lists “Personnel matters including signature lists” among the subjects that should have written procedures and records (4.29).² PIC/S inspectors check “that there are signature and initials logs, that are controlled and current and that demonstrate the use of unique examples, not just standardized printed letters”.¹

Each column comes from a requirement:

• Name and role. The draft Chapter 4 would have people authorised to sign “clearly identified by name” in a signature policy.⁹
• Signature and initials. Handwritten specimens of both, as the person writes them, so each entry has “a unique identifier that is attributable to the author”.¹ Where initials stand in for signatures, the draft adds that “a procedure defining abbreviated signatures should be in place”.⁹
• Added and removed. The log must be “current”;¹ keeping leavers with their end date keeps old records attributable.
• Personal seals. PIC/S says “The use of personal seals is generally not encouraged”. Where a site uses them, a log ties each seal to its owner, and the owner dates each use.¹
• US records. Part 211 names no signature log, but batch and laboratory records must identify who performed and who checked each step,⁴ and a log is how initials are traced to people.

6The same rules in an electronic record.

The system enforces what the card asks of a pen: a synchronised clock, and an audit trail that keeps each correction and late entry with its date and time.³ FDA accepts a controlled electronic signature in place of the “full signature, handwritten” of 211.186(a),⁵ and the draft Chapter 4 says records that exist electronically “should be signed electronically”.⁹ For the principles behind every row, see ALCOA+.

7How it runs in Seal.

Paper records in Seal reads scanned batch records and logbooks value by value, with the writer’s initials and date beside each entry, and flags what this card calls wrong: a struck-through value with no initials, date or reason, a blank sign-off, a ditto mark passed off as a number. Every value keeps its link to the place on the scan it came from.

In an electronic batch record, manual entries keep their user, time, unit and correction history, and a signature carries its meaning. Electronic logbooks keep the event time apart from the time of entry, so a late entry is visible as late, and document control keeps the form version at the point of use current.