GxP/GMP, GDocP, ISO 9000 and documentation
GxP stands for "Good Practice" which is quality guidelines and regulations. The "x" stands for the various fields, for example Good Documentation Practice or GDocP, Good Financial Practice or GFP and so on. There are many instances of these regulations. One instance of GxP is Good Manufacturing practice or GMP.
GMP describes required Quality Management System (QMS) for manufacturing, testing, and quality assurance in order to ensure that products are safe, pure, and effective. GMP has ultimate goal to enable companies to minimize or eliminate contamination and errors which protects consumers from purchasing a product which is not effective or even dangerous. GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.
GMP documentation requirements are aligned with Good Documentation Practice (GDocP). GDocP is the standard in the regulated industries by which documents are created and maintained. It is the systematic set of procedures of preparation, reviewing, approving, issuing, recording, storing, and archiving documents.
The ISO 9000 is a set of standards which deals with fundamentals of Quality Management System (QMS) that helps organizations to ensure that they meet customers’ needs within statutory and regulatory requirements related to a product or service. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfil.
GxP/GMP, GDocP, ISO 9000 are about QMS where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements.
Documentation is the key to compliance with these regulations and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. GMP, GDocP, and ISO 9000 are enforced by regulatory agencies. Auditors pay particular attention to documentation to make sure that it complies with these regulations.
Therefore, in order for an organization to meet these requirements, it must have documentation procedures in place. Documentation is a critical tool for ensuring this compliance.
Purpose of document control and its role in Quality Assurance (QA)
The primary purpose of document control is to ensure that only current documents and not documents that have been superseded are used to perform work and that obsolete versions are removed. Document control also ensures that current documents are approved by the competent and responsible for the specific job people and documents are distributed to the places where they are used.
Document control is an essential preventive measure ensuring that only approved, current documents are used throughout an organization. Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, customer satisfaction, and can even cause death.
The role of QA, in regards to the document control system is one of management and overview.
QA ensures that all documents are maintained in a controlled fashion and that all controlled documents are approved by the appropriate subject matter experts, are consistent with other documents, and are the most current version.
One way that QA ensures this is by being the last signature on all approved documents. All documents - current, obsolete, superseded, as well as all the history on the creation and revision of the document should be kept in Quality Assurance.