GMP AUDIT CHECKLIST – A VALUABLE MANAGEMENT TOOL IN PHARMACEUTICAL INDUSTRY

Abstract

Internal audit is an effective independent activity within a pharmaceutical industry quality management system. It ensures a thorough analyses and evaluation of the company activities and helps prevent, predict and detect mistakes and weaknesses in order to minimize losses. Internal audits help the organization achieve its goals and ensures all the involved parties that a program complies with regulatory and Good Manufacturing Practice (GMP) requirements. A successful audit, is carried out by quality auditor or audit team members, chosen carefully and properly trained. The auditor should gain as much information in advance before the auditing process begins that should help him to design tools useful in achieving the desired results. There are several sections recommended to be included in the GMP audit checklist: Quality management, Personnel, Facility and Equipment System, Documentation, Production System, Packaging and Labelling System, Storage System, and Laboratory Control System. A quality management system (QMS) is a formalized collection of processes, procedures, and documented policies, therefore the auditor looks to find out if the system complies with GMP requirements. As for the personnel, GMP audit checklist cover all the necessary procedures to ensure that the organization’s hiring and supervising practices are in compliance to GMP requirements, such as competences, trainings, dressing, and hygiene of the employees. Documentation ensures traceability of all development, manufacturing and testing activities, so the auditor needs to verify major types of documents that should be kept and recorded. The checklist includes questions addressing review of the layout, construction, size, location of the facility and main areas such as production area, storage, and laboratory, as well as the installation, operation, instructions, maintenance and cleaning of the equipment used in the manufacture. The production and process audit checklist include organization’s various stages of manufacturing such as weighing or measuring of raw materials, appropriate storage conditions for intermediates, In-Process sampling and controls, contamination control, process validation. Checklist points for internal audit of Packaging and Labelling System include elements ensuring the security and quality of packaging and as well elements that relate to labelling such as documentation, storage of starting materials and finished products, packaging and labelling operations. Internal auditing of storage system should prevent occurrence of mix-ups, damage, physical, chemical or microbial contamination. As for the Laboratory Control System, the GMP checklist questions aim to ensure that pharmaceutical products meet safety, efficacy, purity, and stability standards.

The checklist is a good and critical tool to assist in conducting an in-depth and consistent audit and will serve as guideline for evaluation of compliance to standards and documentation, as well as for the effectiveness of the audited process.