The modification RD 824/2010 for the European regulations
The project of the Royal Decree, which modifies Royal Decree 824/2010, of June 25th, continues. It regulates pharmaceutical laboratories, manufacturers of active pharmaceutical ingredients and foreign trade of medicines under investigation. This standard determines the quality requirements of the producing and marketing companies of the pharmaceutical sector.
The modification of the RD 824/2010 becomes necessary to transpose the Commission Directive (EU) 2017/1572, of September 15, 2017 (by which the Directive 2001/83/CE of the European Parliament and of the Council is complemented with regard to the principles and guidelines of good practices for the manufacture of medicines for human use), since according to the RD project it is necessary to delete, from Royal Decree 824/2010 of June 25th, references to the manufacture of investigational medicinal products, since said manufacturing is regulated by Commission Delegated Regulation (EU) 2017/1569 of May 27, 2017, binding on all its elements and directly applicable in each member state.
In order to obtain the opinion of potentially affected individuals, a public consultation of the future standard was carried out, which ended in January 2018. Initially, the object of this consultation was broader since it contemplated measures related to the implementation of the system of security devices in the packaging of medicinal products for human use, which was applied on February 9th, 2019. However, for the purpose of not delaying further the transposition of Directive (EU) 2017/1572, whose transposition deadline expired on March 31st,2018, it has been decided to process separately the part corresponding to the security devices so that his Royal Decree only considers the aspects related to the rules of correct manufacture of medicines for human use.
News in the modification of RD 824/2010
The proposed measures seek to update the principles and guidelines of the rules for the correct manufacture of medicinal products for human use in accordance with Commission Directive (EU) 2017/1572 of September 15th.
Therefore, it is intended to separate into two standards the requirements relating to the rules of proper manufacture of medicinal products for human use and those of investigational drugs, which were previously regulated jointly in the royal decree that is planned to be modified.
This implies the modification of references to the manufacture of medicines in research for human use to refer to Commission Delegated Regulation (EU) 2017/1569 of May 23th, 2017, which complements Regulation (EU) 536/2014 of the European Parliament and of the Council, specifying the principles and guidelines of the correct manufacturing standards and the inspection provisions for medicinal products in research for human use.
Although the adaptation of national to European regulations through the transposition of Commission Directive (EU) 2017/1572 does not include new obligations in compliance with the rules of correct manufacture of medicines, we are going to review some of the novelties that they do include in the AEMPS reform project.
Pharmaceutical quality system
The definitions of “pharmaceutical quality system” and “Good Manufacturing Practices” are modified, as well as some terms in order to reflect the international evolution or the actual use made by inspectors and manufacturers.
Emphasis is placed on the obligation for the laboratories to develop and implement a Quality System and that this is effective, a task in which the Top Management of the company and the key employees of the areas that have an influence on the productive process must participate.
A pharmaceutical quality system that will require the application of risk management principles to ensure continuous improvement, as well as the monitoring and analysis of the effectiveness of the system on an ongoing basis.
In addition, it is expected that the quality system policy is included in a quality manual or similar document.
Rules for staff
Likewise, drug manufacturers will have to have trained and qualified personnel to meet the needs of the Pharmaceutical Quality System. To meet this requirement, organizations must implement training plans that address existing compliance gaps in training.
In addition, pharmaceutical companies must apply hygiene programs adapted to the activities they perform.
Quality control unit
One of the requirements, included in the proposed modification of the RD, is that the Quality Control System is led by a person with the required knowledge and qualifications and that this person is not under the control of the production area.
Document management
Of course, as in any Management System, document management is also affected by the modification of RD 824/2010. Specifically, the need for “The documentation system will guarantee the quality and integrity of the data” as the main change.
With respect to the documents related to the batches of medicines, it is still required to keep them for a period longer than one year, after the expiration date of the medicines that make up the batch.
Regarding electronic data, ease of access is required, especially when requested by competent authorities.
Claims and product recalls
Finally, the proposed modification of RD 824/2010 raises the need for manufacturers to implement a System for the Registration and Examination of Claims, as well as a System that allows the rapid withdrawal of drugs from the distribution network when necessary.
Self-inspection
It is also expected that the pharmaceutical companies carry out self-inspections or internal audits of their quality system, keep a record of these and of the improvement measures that they adapt based on the findings of the same.
Regarding this issue, it is proposed to add a new section where it is indicated that the AEMPS and the health authorities of the autonomous communities will establish and implement a well-designed quality system that will be mandatory for the personnel and the direction of the inspection services. The quality system will be updated when necessary.
In addition, cooperation with the health authorities of the Member States of the European Union is emphasized, where the AEMPS will be able to share the results of their inspections in accordance with the information exchange procedures established and agreed between the national health authorities of the member countries of the European Union, the European Medicines Agency and the countries with which these parties have signed mutual recognition agreements.
Of course, at Oqotech we will be attentive to the course of this initiative. Those companies in the pharmaceutical sector, as a result of the modification of RD 824/2010, require support in the implementation of quality systems, computerization of their processes or validation of their computerized systems can count on our team of consultants.
