science

Good documentation practice

Good documentation practice is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Good documentation practice rather than just read about it. In short: Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current").

Key takeaways

Good documentation practice belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Good documentation practice to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Good documentation practice from memory before moving on to harder problems.

Reference excerpt

Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.

GDocP standards

Documentation creation Contemporaneous with the event they describe Not handwritten (except for handwritten entries thereon) When electronically produced, the documentation must be checked for accuracy Free from errors For some types of data, it is recommended that records are in a format that permits trend evaluation

Document approval Approved, signed, and dated by appropriate authorized personnel

Handwritten entries Adequate space is provided for expected handwritten entries Handwritten entries are in indelible ink Errors (i.e. misspelling, illegible entries, etc.) are corrected and reason is documented Critical entries must be independently checked (SPV, or second person verified) No spaces for handwritten entries are left blank – if unused, they are crossed out or "N/A" (or similar text) entered Ditto marks or continuation lines are not acceptable Correction fluid are not allowed to be used in correcting errors A stamp in lieu of a handwritten signature is not acceptable

Copies of documents Clear, legible Errors are not introduced

Document maintenance Regularly reviewed and kept current Retained and available for appropriate duration Electronic document management systems are validated Electronic records are backed up

Document modification Handwritten modifications are signed and dated Altered text is not obscured (e.g., no correction fluid) Where appropriate, the reason for alteration must be noted Controls exist to prevent the inadvertent use of superseded documents Electronic versions can only be modified by authorized personnel A history (audit trail) must be maintained of changes and deletions to electronic versions Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)

GDocP interpretation From the regulatory guidance above, additional expectations or allowances can be inferred by extension. Among these are:

Prohibition against removing pages – the removal of a page would obscure the data that were present, so this is not permissible. Page numbering – the addition of page numbers, particularly in "Page x of y" format, allows a reviewer to ensure that there are no missing pages. Stamped signatures in Asia – the culture of certain Asian countries, and the controls they employ, are such that their use of a stamp in lieu of handwritten signatures has been accepted. Date and time formats – dates may be written in a variety of formats that can be confusing if read by personnel with a different cultural background. In the context where different cultures interact, a date such as "07-05-10" can have numerous different meanings and therefore, by GDocP standards above, violates the requirement for being clear. Transcription – a transcription of data, where the original document is not retained, effectively obscures the original data and would be prohibited. Transcription may be helpful where the original is of poor quality writing or is physically damaged, but it should be clearly marked as a transcription and the original retained nevertheless. Scrap paper, Post-it notes – intentionally recording raw data on non-official records is a set-up for transcription and is therefore prohibited. Avoiding asterisks as part of the notation of a hand-change – where insufficient white space permits a fully notated hand change, a common practice is to use an asterisk (or other mark) near the correction, and elsewhere record the same mark and the notation. The risk is that additional changes are made by another person who uses the same mark, and now the notation can be interpreted to apply to all changes with the mark. Some will therefore advise against the use of the asterisk. Others will accept it, if the notation clearly includes the number of changes that it applies to, such as, "* Three entries changed above due to entry errors. KAM 13-Jan-2011". There are no known instances of an agency rejecting such a notation.

Enforcement The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs). Departures from GDocP that involved the regulator have included: documentation not contemporaneous, use of ditto marks, signature stamps., obscured original data, Use of pencil, inaccurate records, and not dating changes.

See also Best practice Good manufacturing practice Site Master File

References

Worked examples

Example 1 — a first encounter with Good documentation practice

Start with the simplest possible case. Write down what Good documentation practice claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Good documentation practice before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Good documentation practice ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Good documentation practice

In research: Good documentation practice appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Good documentation practice in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Good documentation practice is common in secondary-school and first-year university syllabi. It links to neighbouring topics Good practice, Pharmaceutical industry, so understanding it makes those chapters shorter.
In everyday life: Look for Good documentation practice outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Good documentation practice in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Good documentation practice means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Good documentation practice out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Good documentation practice in simple terms?

Why does Good documentation practice matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Good documentation practice?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Good documentation practice.