Previously, the Agency operated an extensive checking process of the Marketing Authorisation Holder’s (MAH) printed materials for outer and immediate labelling of centrally authorised medicinal products as well as of the printed package leaflet in all EU languages (‘mock-ups and specimens’). The process largely consisted of a detailed linguistic check of the printed materials of all authorised product presentations for all Member States, against the adopted product information annexes to the Community Marketing Authorisation (MA).
Over the past years, the checking process has been streamlined and simplified in view of a revised translation checking process agreed with the Member States at the end of 2005, and introduced at the beginning of 2006, reinforcing the linguistic checking of the product information annexes before granting of the Commission Decision.
The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA. Because the source
data2 are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (i.e., electronic records).
GMP is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their use. It ensures that quality is built into the organization and manufacturing processes. It covers all manufacturing aspects that include transportation, receipt of raw materials, storage, quality control, and delivery of the product.
cGMP is the part of quality assurance that ensures that medicines are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the Regulatory Authority.