• Documents must be designed and prepared with care. They must be accurate and written in a way that ensures consistency and prevents any errors.
• Content in the documents must be unambiguous. All
documents must have a title, nature, and purpose must be clearly stated.
Content must be arranged in an orderly manner and allow for easy checking.
• Full-text spellings must be used the first time,
with the abbreviation in brackets. Subsequently, abbreviations may be used in
the rest of the document.
• All documents must carry an effective date, and
review date if applicable.
• All documents must be approved; they must bear the
signature (with date) of the persons preparing, reviewing, and approving the
document.
• All documents must have a distinct identification
number and version number.
• Documents must be reviewed periodically and in case
of revision, the version number must change. Only the most current version must
be available; systems must exist to prevent the use of documents that have been
superseded.
• No document must be handwritten. However, there may
be provision for the entry of data by hand (for example, in the Batch
Manufacturing Record, where real-time data entries are made). Sufficient space
must be available for making the entries, which must be made with indelible ink
in a legible manner. Using temporary recording on scraps of paper etc. is
totally prohibited.
• If a correction is to be made to a record/entry, it
must be made in such a way that the original information is not defaced.
Overwriting and use of white ink or correction fluid or sticky notes to make
corrections is prohibited; however, it is acceptable to strike through the
incorrect entry with a single line and write the correct entry next to it. The
correction must be accompanied by a signature/initial and dated. Where
necessary, the reason why the correction has been made must also be recorded
such as ‘typographical error’ or ‘calculation error’, or ‘recording error’.
• Entries in the record must be made immediately –
that is, at the time of the particular action.
• Signature and date must accompany the entry where
specified. No person should sign for another staff unless specifically
authorized. Forging of initials or signatures is prohibited.
• Master copies of documents must be stored securely.
Only authorized persons must have access to these. Copies may be made for
issuing; while handing over the copies, details have to be recorded of who
issued the document, to whom, and the date and time of issue.
• Copies reproduced from master documents must be
clear enough to allow comprehension.
• If printouts are obtained on thermal paper from an
instrument, they must be photocopied (as the print will fade over time). Both
the original and photocopy labeled as “Copy of original” must be attached to
the report.
• Critical records must be stored securely, protected
against loss, falsification, or any damage by the elements, with limited access
to only authorized persons.
• Copies of critical records must be available in
electronic form or paper or microfilm and be stored separately from the
originals.
• In the case of electronic data processing methods,
access to the master templates and documents must be given only to authorized
persons to enter data or modify it in the computer. Passwords and biometrics
may be used to control access.
• If electronic signatures are to be used, they must
be unique to the person. Such electronic signature is generally by means of an
identification code which comprises a username and password. Using the saved
digital image of the hand-written signature of the person is not permitted.
• Retaining important documents (such as
developmental history, technical reports, validation reports, production and
control records, training records, distribution records, etc.) must be done in
keeping with regulatory requirements. For example, records about the
production, testing, and distribution of a batch of drug products must be
retained for a minimum of 1 year following the expiry date of that batch.
Common Documentation Errors
1. Illegible entries.
2. Falsified data (date/time/version number).
3. Signatures missing.
4. Raw data to support results missing.
5. Missing documents.
6. Discarding data that does not match requirements.
7. Invalid and fabricated data.
8. No recording of activities.
9. Data manipulation/deletion.
10. Incomplete records.
Excerpt from a warning letter issued by USFDA to a firm
citing lack of adequate documentation practices.
“…Your quality unit (QU) lacks appropriate responsibility
and control over your drug manufacturing operations.
During the inspection, our investigator observed discarded
cGMP documents and evidence of uncontrolled shredding of documents. For
example, multiple bags of uncontrolled cGMP documents with color coding
indicating they were from drug production, quality, and laboratory operations
were awaiting shredding. Our investigator also found a blue binder containing
cGMP records, including batch records for U.S. drug products, discarded with
other records in a 55-gallon drum in your scrap yard. CGMP documents in the binder
were dated as recently as January 21, 2019: seven days before our inspection.
Your QU did not review or check these documents prior to disposal….”
“…The uncontrolled destruction of cGMP records, and your
lack of adequate documentation practices, raise questions about the
effectiveness of your QU and the integrity and accuracy of your cGMP records….”
“…Your quality system does not adequately ensure the
accuracy and integrity of data to support the safety, effectiveness, and
quality of the drugs you manufacture…”