The chapter 4 relates to the documentation. A good documentation is an essential part of the quality management. Moreover, it constitutes a key function for the production in compliance with the GMP regulations. The target of the documentation is to control, monitor and record all activities directly or indirectly affecting the quality of pharmaceutical and medicinal products.
As an introduction, chapter 4 lists the documents required according to GMP which must be included in the documentation. The documentation consists of the site master file, any type of regulations resulting from instructions and requirements and protocols or reports of any actions according to the regulations. The individual document types and the media used have to be specified in the vendor’s quality management system. Respective checks should be introduced to ensure the accuracy, correctness, availability and legibility of the documents. The documents must be available during the entire retention period. These aspects apply for paper-based and electronic documentation systems but also for mixed forms, so called hybrid systems. However, it is usually impossible to regard paper printouts as complete. Complete means in this case that the printout is equipped with all relevant data such as raw and metadata. As a result, electronic data is additionally used for research purposes and to check the reproducibility of the results. Thus, the paper printouts must contain unique references pointing to the electronic data.
In case of the batch documentation and the batch release, chapter 4 requires a mandatory electronic batch release, if the data predominantly exists in digital form. The chapter 4 of the EU GMP guideline also requires to validate complex systems including software and to check them regularly. In this context, every change or entry in a document must be signed and dated. Despite the respective change, the data must be stored in a way that the original information can also be retrieved. The reason for the change must be recorded.