What Do You Mean by Good Documentation Practices?

Sep 01, 2014
By Spectroscopy Editors
Volume 29, Issue 9

The U.S. Pharmacopeial Convention (USP) has issued a draft general chapter <1029> on good documentation practices for comment. What can we learn from this draft?

In the May 2014 issue of Pharmacopeial Forum, the U.S. Pharmacopeial Convention (USP) issued a draft general chapter on good documentation practices (GDP) (1). Note that this GDP must not be confused with the GDP in the European Union (EU) "good manufacturing practice" (GMP), which stands for good distribution practice in that context. When GDP is used in this column, the "D" will mean documentation.

EU GMP Chapter 4 on Documentation

Before starting to review the United States Pharmacopeia (USP) draft general chapter, let us look at what exists in the regulated world as documentation is the key to compliance with either good laboratory practice (GLP) or GMP regulations. As the section titled "Principle" in EU GMP chapter 4 on documentation states in the first sentence, "Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements" (2). This statement can also be applied to GLP or any other quality system such as ISO 17025 or ISO 9001.

Chapter 4 also goes further in describing the types of documents that are possible in a regulated organization:

  • Site master file: This describes the GMP activities of a manufacturer. We will not discuss this document in this column.
  • Instructions: Includes specifications, protocols, analytical procedures, and standard operating procedures
  • Records or reports: Evidence that instructions have been executed


Figure 1: Document types as defined by EU GMP chapter 4. Adapted with permission from reference 2.
These document types are shown in Figure 1. Of these, the principle (2) describes the two main types of document as follows: "There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports" (2). As shown in Figure 1, the execution of an instruction results in the generation of a record, records, or a report. It is the existence of accurate and reliable records that demonstrate that instructions have been followed and, therefore, compliance with GMP regulations.

Chapter 4 (2) goes into more detail about records and reports:

  • Records: Provide evidence of various actions taken to demonstrate compliance with instructions — for example, activities, events, investigations, and, in the case of manufactured batches, a history of each batch of product, including its distribution. Records include the raw data that is used to generate other records. For electronic records, regulated users should define which data are to be used as raw data. All data on which quality decisions are based should at least be defined as raw data.
  • Certificates of analysis: Provide a summary of testing results on samples of products or materials (1) together with the evaluation for compliance to a stated specification.
  • Reports: Document the conduct of particular exercises, projects, or investigations, together with results, conclusions, and recommendations.

From Chapter 4 (2) we can draw up some basic requirements for documentation for any quality system:

  • Say what you do: Have an instruction to document a repetitive task such as an analytical method or a standard operating procedure (SOP)
  • Do what you say: Follow the instruction and if there are any deviations from the procedure document them
  • Document it: Generate a record to show that the instruction was followed.

This chapter (2) also notes that "The term 'written' means recorded, or documented on media from which data may be rendered in a human readable form." In Chapter 4 speak, a document (instruction or records) does not exist only on paper, it can be any medium as long as it can be converted into a readable format.

Chapter 4 goes further to discuss heterogeneous systems (hybrid systems where there are electronic records with handwritten signatures on paper printouts) and homogeneous systems (electronic signatures and electronic records). The discussion is confused by the mention of raw data in the records section of Chapter 4, shown above. However, the term raw data is not defined in either EU or US GMP as it is a phrase used in GLP (3,4). What does raw data mean in a GMP context — especially as raw data can create other records? The GMP regulations are silent on this subject.


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