Guidelines for Creating and Correcting Records
It is essential to adhere to Good Documentation Practices when creating and correcting GMP records, in order to ensure their authenticity and accuracy.
It is essential to provide a thorough understanding of the need and importance of Good Documentation Practices (GDP) as it pertains to the Biopharma, BioTech and medical device industries. GDP involves the appropriate handling of written or pictorial information pertaining to activities and procedures followed, or results obtained during procedure execution. In particular, GDP applies to GMP records, which specifically document GMP activities that take place during the packaging, holding, and distribution of products. GMP records may include original documents and true copies, such as photocopies, or even electronic files and data. Appropriate documentation of GMP information is essential to ensure that an organization, or an individual within the organization, does not falsify data when drafting or revising these records.
GDP requirements are standard for all GMP records and documentation. For example, it is acceptable to record the date as either Day/Month/Year, or Month/Day/Year. However, certain organizations may choose to use only one of these formats in all company documentation. As such, it is essential for company personnel to closely review and understand the guidelines outlined in the organization’s standard operating procedure (SOP) for GDP, in order to avoid any variation between records.
There are certain rules that must be adhered to when creating a record for a GMP activity. To begin, GMP documentation must always be done on permanent forms, logs, or datasheets. Recording data on temporary sheets, such as Post-It notes and scrap paper, is not permissible. Also, the individual making an entry on a record is required to enter actual data, signatures or initials each time an entry is made.
In the case that a single-entry field does not apply to a specific activity, “not applicable,” or “N/A,” must be written in the provided space. If adjacent entry fields of a section do not apply to an activity, the entire section must be crossed-out using a single line. The individual generating the record would also need to enter “N/A” in the section, and initial and date.
If there is insufficient space provided to record an entry on a document, footnotes may be used and explained fully, with initials and the date. One can use a single footnote multiple times on the same page of the document, provided the explanation included in that footnote is applicable to multiple entries. It must be ensured that hand-written entries are made using a permanent blue or black pen.
In the case that an error has been made, a single line must be used to eliminate the incorrect entry. The correction can then be entered near the error, and a reason must be recorded for the correction. A numbered footnote may also be used to make a correction and record the reason for it. It is important to remember that it is not permissible to cross-out a group of errors with one line; a separate line should be used for each error, and this should be followed by the respective corrections. Lastly, all corrections must be signed, initialed, and dated by the originator or the supervisor using the date the correction is made on. Adherence to this simple process ensures that organizations comply with data integrity standards.