Good Documentation Practice (GDP) Onboarding Course

A warm welcome to FinVector Vision Therapies Oy (FVT)! We're delighted to have you on board the GMP4 project.

All suppliers and contractors who will be producing qualification documents and records are expected to complete this short online course.

When you've finished with this GDP onboarding course, you will:

Please read each section. At the end of the each section we will ask you multiple-choice questions to make sure that you have received and understood the information provided. Only one answer is correct to each question.

We value your time and thank you for completing the course! Good luck!

About Good Documentation Practice (GDP)

In the GMP World Good Documentation Is a Must

The overall purpose of documentation is to ensure patient safety. This is done by

  • providing sufficient instructions to the manufacturing personnel
  • keeping records of what has been done.

 

Documentation should, as appropriate, provide information on:

  • when, where, who, why and how should a task be completed
  • whether the tasks were actually completed as they should be.

 

Poor or incorrect documentation is a risk to patient safety!

 

Therefore the authorities, e.g. FDA and EMA have enforced regulations on GPD.

Qualification and validation documentation must fulfil GDP.

 

In the following sections, we will go through the authorities' and FVT's general expectations on documentation.

Why is good documentation so important?

  • Because the authorities say that it is
  • Because poor or incorrect documentation is a risk to patient safety
  • Because it is a general expectation

General Expectations on Documentation

Documents Shall Be Clearly Written

Documents shall be clearly written

When a reader reads your documents, it should be as clear as possible

  • what the purpose and scope of the document is
  • what documents it belongs to (references)
  • what the document contains
  • who has written the document


Try to explain the above mentioned aspects as clearly as possible, but keep in mind that much extra text just clutters the document, and requires more focus from the reader.

Records Must Be Permanent

Records must be permanent

It is a requirement that documents are permanent. This means that it must be possible to read the contents even after a long period of time. This also includes manual entries done in the documents. Therefore:

  • Do not use a pencil
  • Use indelible ink (blue or black) when producing normal entries


Printouts on thermal paper fade fairly rapidly. Therefore:

  • Copy any thermal printouts on normal paper before you attach them to a report
  • Attach the original and the copy securely together

Entries Must Be Legible and Traceable

Entries must be legible and traceable

Any entries that are not legible ("readable") are unusable.


Make sure that your manual entries can always be read!


In case a page or document is made completely illegible for some reason:

  • do not discard the original, but attach it to the new version of the document as such
  • provide an explanation


Always date and sign the entries you have made!

Documents Must Be Reviewed and Approved

Documents shall be reviewed and approved

Protocols, programs, plans or alike should be reviewed and approved by the appropriate functions at FVT, before they are used.

Also, have another person in your own organisation review documents, before you transmit them to FVT for review and approval.

Initials and Signatures Must Be Traceable

Initials and signatures shall be traceable

When making entries to your protocols

  • assemble all personnel in a list
  • record for each person: person's name, company, signature and also initials, if initials are used


It is allowed to use initials when signing, but make sure the initials are traceable!


The requirement above applies to all personnel making entries to protocols. The reason for this is that it should later be clear who has performed, reviewed and approved tests.


Never sign for another person!


In case a system or piece of equipment supplied produces electronic records, it shall be clear who has operated the equipment.

Documents Must Have Page Numbers

Documents shall have page numbers

The total number of pages in a document should be clear. Therefore the documents should have page numbers.

Use format "X of Y" when adding page numbers to your documents.

Review and approval?

  • The qualification must be performed with a document that has been reviewed internally only
  • The qualification protocol must be approved by relevant functions at FinVector prior to starting any work
  • It is important that the documentation is approved only after execution

What does it mean that signatures are traceable?

  • Traceable signatures mean that readers can afterwards tell whom the signature belongs to
  • Traceable signatures mean that the signatures are written in a legible handwriting
  • Traceable signatures mean that there is a certificate that the person is competent

Some Dos and Donts

General Requirements, Filling out the Protocols

Filling out your protocol

All fields should have an entry.

  • Use N/A or NA to indicate that a certain item is "not applicable"
  • Use a straight line through a field to indicate that it is not needed
  • If there are several adjacent fields that would be left without entries, use a single line to cross out all the fields, mark with N/A (or NA) together with date and initials or signature.
  • Provide explanations, if necessary.


Do not leave empty fields in your protocol!


Do not use "ditto" marks to mark a repeated entry. Write the entry in each field.

General Requirements, Making Corrections

Making corrections in your protocols

When making corrections:

  • use a single line to cross over the incorrect or illegible entry
  • write the new information, and date and sign the correction
  • make sure the original entry is still legible, if possible

General Requirements, Papers

Paper format

Do not use loose papers, scrap papers or post-it-notes as these can easily be lost.


Always use proper papers and secure them to the documentation!

Project-Specific Requirements, Date and Time

Date and time format

The date formats used in various countries differ. There are formats with the sequence day-month- year, year-month-day, month-day-year. Therefore the dates can be unambiguous depending on the reader's origin.

In order to make date formats unambiguous to the reader, please

  • preferably use the format day-month-year, e.g. 22-Nov-2017
  • if your company uses another format, define the acceptable time format in your protocol, so that it is clear to the reader, which format has been used


Times should be written in the 24-hour format. E.g. 13.00 means 1 PM.

Project-Specific Requirements, Attachments

Attachments

Main document and attachments should cross-reference each other in an unambiguous way.

Example:

Say that you have your main document Protocol1, which gets two attachments ("Att1" and "Att2"). The attachments should be mentioned in the document (e.g. "See Att1 and Att2 for details"). The two attachments should reference the Protocol1 (e.g. "Att1 to Protocol1", "Att2 to Protocol1"). The reference should be written in the header of the attachment.


  • Include reference to attachments in main protocol
  • Include reference to main protocol in attachments
  • In case there are many attachments, they can reference a certain test section in the protocol (e.g. Att1 to test 7.1)



How should you handle empty fields?

  • It is a good thing to leave empty fields in the protocol, as it makes it possible to make additional entries later
  • Empty fields should be filled out with "ditto" marks to indicate that you have filled them out
  • Empty fields should either be crossed out or marked with N/A to show that they have been observed and left empty for a reason

How about dates?

  • The selected date format should be unambiguous
  • It does not matter what date format is used
  • Dates? I don't do dates - ever

Read Me: Final Words

Some Final Words

You have now completed the course.

Submit your results, whereby your information is automatically sent to FVT.

Please note that all questions must be answered correctly before your training is approved. In case you do not reach the required amount of correct answers, please revisit the training sections and answer the questions again.

If you feel that you still need some more information on our expectations regarding your qualification documents, please do not hesitate to contact us. The contact details are found below.

Finally, we wish to thank you for participating in the training!


Contact details:

Tony Lönnbäck, CQV Lead in GMP4 project, +358 40 507 9852 or [email protected]