Telstar addresses the standardised management mechanisms that ensure data integrity in the GMP/GDP environment within the pharmaceutical industry

Telstar will be taking part at FarmaForum 2017 (Madrid, 1-2 March 2017), the congress for the pharmaceutical, biotechnological, cosmetic and laboratory technology industries. Within the framework of this event, Fernando Geijo, Quality Assurance Manager for R&D & Pharmacovigilance at Telstar, will be offering a workshop where, under the title Data Integrity: from theory to reality, he will be addressing how to establish standardised mechanisms that ensure data integrity and the management thereof by using processes that can be audited against predetermined standards. He will also be analysing the expectations generated by the growing interest from the international competent organizations in the achievement of objectives in terms of Data Integrity. In addition, Beatriz Tejerina, Expert Consultant in Quality and Auditing Systems at Telstar, will be unveiling how to prepare and act vis-à-vis the GMP inspections run by various regulating bodies. This session will take place on Wednesday, 1 March at 10.00 am.

Fernando Geijo will be analysing the practical implications of the position taken by the regulating authorities on the preservation of data integrity in the GMP processes, by using Data Governance formulae in an environment where trends are already appearing in organisations to fulfil the envisaged targets. The speaker will also be examining the pros and cons of the management of electronic and paper registers according to the opportunities offered by technological developments and data integrity requirements. During Farmaforum 2016, Geijo addressed the new trends in data integrity which, at that time, were taking shape and the most important elements to be considered when building a strategy for implementing a Data Integrity policy. One year later, organizations such as EMA have included a series of Q&A on their web page on this subject, the WHO has published a technical guide applicable to all GxP systems and the PIC/S has developed a guide for GMP/GDP inspectors.

In turn, Beatriz Tejerina, Expert Consultant in Quality and Auditing Systems at Telstar, will be providing information on how to prepare and act vis-à-vis the inspections run by various regulatory agencies, from a more practical perspective she will be analysing the differences and similarities between reference agencies such as US FDA, PMDA, ANVISA, GGCC and COFEPRIS, amongst others.

Data Integrity: from theory to practice

Although the term Data Integrity appears in all of the sector’s Good Practice guidelines as one of its objectives, in recent years this concept has taken on a new direction. The British agency MHRA published the first version of a guide in January 2015, and later modified it in March of the same year. In 2016 the EMA agency included specific Q&A on its web page, the WHO has updated Annex 5 of Technical Report No. 996 Guidance on good data and record management practices and the Pharmaceutical Inspection Convention (PIC/S) has published, still in draft form, document PI041-11 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. With this scenario, the competent international agencies are expressing an increasing interest in Data Governance, the set of policies and measures set up by an organisation to maintain and ensure the precision and consistency of data throughout its life-cycle, irrespective of the format and means on which they have been generated, registered, processed, filed and used.

The GMP and GDP are focused on establishing processes that guarantee the efficacy, safety and quality of the medicines placed in patients’ hands. Throughout these processes, there are tangible products such as the medicines in their various stages, which can be monitored and controlled. However, considering data management as a process in itself, and not as a subsidiary element to each productive process, the datum is perceived as an intangible element, in which there must be the utmost confidence regarding its reliability, without the need for direct control mechanisms about its integrity.

For Telstar, the challenge lies in establishing transverse standardised mechanisms in the organisations, irrespective of the medium on which the information is held (paper or electronic) to ensure the integrity of the data and the management thereof by using processes that can be audited against predetermined standards. During the workshop, Fernando Geijo will be analysing what these mechanisms are and the expectations the authorities hold regarding them.

Speakers

Fernando Geijo holds degrees in Organic Chemistry and Biochemistry and has a Ph.D. in Bio-Organic Chemistry from the University of Barcelona (Spain). He also attained a Master’s in Quality Management from the Polytechnical University of Catalonia (Spain). He has worked in the pharmaceutical industry since 1985 and has been a Consultant since 2000. He currently manages Quality Assurance services for R&D and Pharmacovigilance within the Consultancy Division of Telstar.

Beatriz Tejerina is graduated in Physical Chemistry from the UAM. From 1985 she worked for 29 years in US multinationals for the pharmaceutical industry. During those years she covered various functions in Quality Control, API manufacturing and Quality Assurance (including managing Audits and Compliance). Since 2014 she has been working as a consultant for Telstar implementing Audits and Quality Systems.

Telstar: stand 122A

Telstar, which is sponsoring the event, will also be present at FarmaForum 2017 as an exhibitor (Stand 122A). Telstar, part of the azbil Group, is an international company that develops global and complete solutions in engineering, construction, process equipment design and manufacturing and consultancyservices, and validations, qualifications, calibrations and after-sales services for the pharmaceutical, biotechnological, cosmetics, medical products, hospital, laboratory and research centre sector.