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There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of document.

Documentation should describe all major stages of the process of pharmacy preparation: the decision to start preparation of a medicine, the drafted formulation, the production method, supporting data for the current preparation, the controls and tests during and after preparation and at release of the product.

Good documentation practice (GDocP), also known as good record-keeping practice or GRK, is a set of internationally accepted guidelines that ensure the reliability, integrity, and veracity of data collected during the research, development, manufacturing, and testing of drugs and medical devices.

These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.? A trial master file should be established at the beginning of any research study and maintained throughout the study.

?Documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any. documents. ?The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer.

The main purpose of documentation is to define procedures in written to the pharmaceutical manufacturer so as to minimize the errors, misinterpretations due to oral or casually written communication and to allow the tracing of historical batches which eventually leads to the quality of the product.

Electronic Document Management System (EDMS)

Documentation is essential to quality and process control There needs to be some level of cohesion so that you don't look sloppy or uninformed. Documentation encourages knowledge sharing, which empowers your team to understand how processes work and what finished projects typically look like.