Electronic Data Recording in the Pharmaceutical Industry

Good Manufacturing Practice (GMP) was initially prepared by the FDA bureau under the Health Department of the United States to prevent contamination of products that directly affect human health—such as food, pharmaceuticals, cosmetics and medical devices—at any point in the production and distribution chain. The GMP version prepared by the FDA, the GMP version prepared by the World Health Organization and the GMP version adopted by the European Union (EU-GMP) are substantially similar in content. Turkey first implemented this guideline, defined as GMP, under the name 'Guide on Good Manufacturing Practices for Pharmaceutical Products', published on 03.03.1994. Rules to be followed in production were included in this guide with precise wording, taking into account the recommendations of the World Health Organization. Subsequently, based on the cosmetics regulation adopted by the European Union in 2010, GMP certification began to be required as of July 2013 for products to be sold or exported in our country. In European Union countries, the inspection and documentation of whether production is carried out in accordance with GMP principles is performed by national regulatory bodies. In Turkey, the 'Good Manufacturing Practice Certification Directive' prepared by the Turkish Standards Institution (TSE) entered into force in November 2012. According to this directive, the Product Certification Center (ÜBM) and the 'Good Manufacturing Practice (GMP) Certification Commission' established by TSE examine reports from the expert approval committee and make decisions. The 'Good Manufacturing Practice (GMP) Guide for Human Medicinal Product Manufacturers' enacted by the Turkish Ministry of Health in 2017 includes a detailed definition of 'Pharmaceutical Quality System'. The Pharmaceutical Quality System, which contains closely related topics such as Good Manufacturing Practice, Quality Risk Management, design and implementation, must be fully documented and monitored.

Under the heading 'Documentation and Records' in Part 1, Section 6 of the Guide, provisions are made regarding the preparation, storage, control, distribution and reporting of documents related to the production of semi-finished products and active substances.

In the same section, regarding reporting: "Entries in records shall be made in indelible form in the space provided and directly after the activity has been carried out, and the person making the entry shall be identified. Corrections to entries shall be dated and signed, and the original entry shall remain legible" and "if electronic signatures are used in documents, they shall be authenticated and secure". The Annex on Computerized Systems requires that electronic signatures have the same effect as wet signatures within company boundaries and be permanently linked to the relevant records. In the pharmaceutical industry, objectives such as minimizing downtime, continuously improving quality and achieving error-free production runs are of great importance. To achieve this objective, process control at more points and reliable monitoring is required. The precision of process equipment used in the preparation of semi-finished and active products, its suitability to pharmaceutical industry conditions and its documentation are important aspects from a GMP perspective. One convenient way to maintain these records is through electronic data loggers. Next-generation electronic data loggers can fulfill the principles specified in the GMP guideline, such as protecting important process data from external interference, accessing it when needed, and encrypting it so that only authorized persons can access it. Recorded information can be transferred to a computer or to a SQL database in a manner that cannot be altered. In this way, every moment of the process is recorded reliably at the desired frequency and can be traced retrospectively.   Egemen Demirkol Food and Pharmaceutical Industry Manager Endress Hauser A.Ş.