Proper documentation is the backbone of current Good Manufacturing Practices (cGMP) and in the regulatory world, it is commonly held that “If it isn’t documented, it wasn’t done!”
Documentation is the most essential part of a quality
management and quality assurance system for the following reasons:
• Documents are evidence of all manufacturing and
testing activities and provide traceability to verify if certain actions were
performed or not.
• Written procedures provide clarity and ensure there
are no errors that may arise during spoken communication.
• Records, documents, and reports give a clear
picture of what has been done and is ongoing work, and it also helps to plan
better for the future.
• A comprehensive review of the documents maintained
in a pharmaceutical facility is often the key used by regulatory bodies to
assess the quality function of the facility.
• Accurate and clear records allow the critical
reviewing of processes, which can help to improve quality and create
cost-saving measures too.
• Good documentation is a must to attain ISO
certification and any other industry-specific certifications.