Good documentation practice

Good documentation practice (mostly abbreviated as GDocP in order to be able to differentiate it from “ good distribution practice ”, also abbreviated as GDP) is a term used by the pharmaceutical industry to describe the standards for how documents should be created and maintained. Responsible authorities are responsible for eliminating discrepancies of any kind through comments and observations.

Principles of the GDocP

Good documentation is an important aspect in the area of ​​the quality assurance system . All types of documents that are used should be fully defined in the manufacturer's quality management system. Documentation can be done in many different ways, including paper, electronic, or photographic media. The aim here is to control, monitor and record all activities (which are directly or indirectly related to the quality aspects of the product) in the documentation system used. The quality management system should include detailed and sufficient records to facilitate a general understanding of the requirements for everyone. This serves to take into account a satisfactory documentation of various processes and evaluations of observations and thus to be able to demonstrate a continuous application of given requirements.

There are two general types of documentation: On the one hand, there are certain regulations (instructions, requirements) and, on the other hand, there are protocols or reports. Good documentation practice should be adapted to the respective type of documentation.

Appropriate controls should also be introduced to ensure the availability, correctness, legibility and accuracy of the documents. Instructions given should be free of errors and available in writing at all times. The term "in writing" is used herein to mean recorded or documented in media. It should be possible to reproduce these in data in a form that can be read by humans .

General requirements

Basics	GDocP requirements
Clear documentation	All documents must be written in an accurate and consistent manner, which helps prevent errors. If different documents are used in conjunction with one another, each should refer to the other. With the help of official document numbers, it must be ensured that there is a connection between two or more documents / records.
Non-removable ink	In order to ensure that all records that have already been completed or that have yet to be completed are legible even after a long time, suitable ink must be used. This rules out the use of pencils or removable ink. The chosen color should be specified in advance. As a rule, blue or black are selected, as in the past scanner technology could only recognize and copy colors to a limited extent. Nowadays, however, with the more advanced scanners and color copiers, this is no longer a problem.
Legible handwriting	An illegible document is useless, which is why one must ensure that in the case of a handwritten document, the handwriting is legible. All entries must be entered at the moment in which the work steps are carried out. These should also be clearly identified and dated. Of course, this also applies to electronic documents; these must also be linguistically clear and unambiguous.
Review and acknowledge	Documents and records should be checked by someone who was not previously assigned to ensure that the information written is accurate and free of errors. A sub-step with the date of the expert confirms that the documents have been checked.
Staff signature	Handwritten signatures must be listed individually and in the signature register. This ensures that every signature can be traced back to an employee or contract worker. Employees do not have the right to sign for a colleague unless they have been instructed to do so. Under no circumstances may signatures be forged. The administration of the signature register should be a regulated process, which is checked regularly to ensure that the register is always up to date. New employees should enter their signature during training. The register must also indicate when employees are no longer part of the company. Electronic signatures must meet the same requirements.
Signed delegation of responsibility	In the event that an important employee is absent for a long period of time, he / she must delegate their duties to another equally qualified person. The delegation must: - predefined in a document (e.g. SOP) or - documented with the names of all parties involved and - signed by the person delegating their duties. The delegation must also be approved by a senior employee.
Pagination	GMP documents should be numbered and use the following standard of 'X of Y' to indicate the total number of pages within the document.

GDP / GDocP standards

Documentation creation

• It should be described at the same time as the event
• Not handwritten (apart from the existing handwritten entries)
• If the documentation is created electronically, it must be checked for accuracy
• Should be free of any errors
• For some file types, it is recommended that recordings be in a format that allows trending

Document approval

• Approved, signed and signed by appropriately authorized personnel

Handwritten entries

• Adequate empty space should be reserved for any additional handwritten entries
• Handwritten entries must be written in indelible ink
• Errors (e.g. spelling errors, legibility of the entries etc.) must be improved and the reason for the improvement must be stated
• Critical entries must be checked independently (SPV, verification by a second person)
• No spaces are left empty for handwritten entries - should these remain unused, they must be crossed out or "N / A" (or similar text) entered
• No sub-characters or extension characters are allowed
• A mark instead of a handwritten signature is not allowed

Copies of documents

• Clear, legible
• Errors are not accepted / introduced

Document maintenance

• Regular review and update
• Safekeeping and availability for a reasonable time
• Electronic document management systems are made valid
• Electronic records are secured

Change of documents

• Changed text is not darkened (e.g. no correction fluid such as Tipp-Ex or similar)
• The reason for the change must be noted at the appropriate point
• Controls are carried out to prevent careless use of replaced documents
• Electronic versions of the documents may only be changed by authorized personnel
• Access to electronically available versions of documents must be protected by passwords or other means
• The course / history (audit trail / balance sheet) must be maintained despite changes and deletions
• Supporting documents can be attached to the original document as an attachment for clarification or the inclusion of data / data recording. Attachments should refer to the original documents at least once. Ideally, each page of the annex should be clearly marked (e.g. mark with "Annex X", side X of Y, signed and dated by the person who attached it, etc.)

Interpretation of GDP / GDocP

Additional expectations or allocations through extensions can be derived from the above implementation management. Among these are:

• The ban on removing pages - Removing a page would make the files in front of it insignificant and is therefore not allowed.
• The Stamped Signatures in Asia - the culture of certain Asian countries and the controls they use have recognized that they are allowed to use a stamp of their signature.
• Date and Time Formats - Dates can be written in a wide variety of formats which can be confusing for personnel from different cultural backgrounds. Where different cultures meet, a date like "07-05-10" can have different meanings and thus violate the above-mentioned GDocP standards, in which clarity is required.
• Transcription / Transcription / Protocol - Transcription of a file / document in which the original document is not kept makes the original files insignificant and is therefore prohibited. Rewriting can be useful if the original is poorly written or the document is physically damaged. However, this should be clearly marked as a copy / paraphrase and the original should be kept.
• Scratch paper, sticky notes - Intentional recording of rough / raw data on unofficial records is a planned transcription / transcription and is therefore prohibited.
• Avoid Annotation Marks (*) as part of a Note of Handwritten Change - Where there is not enough space for a note, it is common practice to write a Annotation Mark (or other character) near the entry to be corrected and then the same Enter the characters and the note in a free space. There is a risk here that additional changes can be made by someone else to the document which uses the same annotation mark. This applies the note to all changes with the sign. That is why there are voices against the use of annotation marks. However, others will accept them provided the note clearly includes the number of changes being referred to, such as
• "Three entries above have changed due to input errors. CAME 13-Jan-2011 ". So far there are no examples of agencies that would reject such a note.

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1. ↑ PharmOut white paper: How to implement Good Documentation Practices. Retrieved January 19, 2017.
2. ↑ ^{a b c d e f g h i j k l m n o p q r} European commission Health and consumers directorate-general, Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation. Retrieved January 19, 2017.
3. ↑ ^{a b c d e f} FDA Guidance for Industry - Computerized systems used in clinical trials. Retrieved January 19, 2017.
4. ↑ ^{a b c d e f g h} WHO Technical Report Series, Forty-fifth report. Retrieved January 19, 2017.
5. ↑ ^{a b c d e f} Official Journal of the European Union Commission directive 2003/94 / EC of 8 October 2003. Accessed January 19, 2017.
6. ↑ ^{a b c d e f} ICH Harmonized tripartite guideline, Good Manufacturing Practice guide for active Pharmaceutical Ingredients, Q7. Retrieved January 19, 2017.
7. ↑ ^{a b c d e} FDA Title 21 Food and Drugs, Volume 4, Part 211, Subpart J — Records and Reports. Retrieved January 19, 2017.