◆ How is the Data Governance System to be implemented in your Company? (07-Feb-18 ECA)
In the PIC/S draft guideline “Good Practices for Data Management and the Integrity in Regulated GMP/GDP Environments”, section 5 describes the “Data Governance System” as well as authorities’ requirements regarding this system in pharmaceutical companies.
“Data Governance” describes the entirety of all measures taken in order to ensure data integrity. It’s supposed to make sure that all data is complete, consistent and handled properly throughout the lifetime of the data, from their creation to their deletion.
But how can such a system be implemented?
Data governance systems must be implemented into a company’s present quality management system. The accountability and responsibility of GMP relevant data (data ownership) over its entire lifecycle must be specified in the Data Governance System.
The senior management is responsible for the implementation of a Data Governance System and must provide the necessary resources. With an effective Data Governance System, management can show that data governance requirements were implemented successfully. This includes appropriate organisational culture, understanding for the criticality of data as well as the risk of data and the data lifecycle. It also includes communication with the personnel on all levels and how an organisation enables and encourages individuals to report their own errors. This reduces the intention to falsify, change or delete data.
Manufacturers and analytical laboratories must develop and employ a system which allows an acceptable state of control based on the data integrity risk. This data integrity/data governance system is to be fully documented and justified.
If long-term measures are identified that have to be taken to reach the desired level of control, provisional measures must be implemented in the meanwhile so as to mitigate risk. The efficiency of these provisional measures is also to be verified. Also, if provisional measures are taken, senior management must be informed accordingly. Additionally, these measures must be included into the regular reviews.
You will find the complete requirements and specifications for the data governance system in the “PIC/S Document “Good Practices for Data Management and the Integrity in Regulated GMP/GDP Environments“.
◆ Revision of EU GMP Chapter 1 to enhance Quality Risk Management (28-Feb-18 ECA)
According to the EMA’s Work Plan for the GMP/GDP Inspectors Working Group for 2018, Chapter 1 of the EU-GMP Guidelines (Pharmaceutical Quality System) will be revised. The task is to “draft a proposal to amend the chapter in order to encourage industry adoption of risk-based approaches to prevention of shortages“.
The document is also referring to the HMA/EMA Task force on availability of authorised medicines. If drug shortages are related to manufacturing or quality issues, will fall into the remit of EMA. The Agency has worked on how to best manage these shortages since 2012, resulting in the development of a comprehensive set of documents to support regulatory authorities in addressing shortage situations due to GMP non-compliance/quality defects. The task force is part of these activities.
One of these documents is the “Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems” (EMA/590745/2012). This reflection paper might give hints to what might be included in the revision of chapter 1. This paper for example refers to the increasing globalisation with extended manufacture and supply chains and its associated risks. It is mentioned that “industry’s risk management tends to be very reactive rather than proactive” and that there is a need to bring “a change in a manufacturer’s approach to quality risk management and supply chain security“.
◆ Revised Ph. Eur. monographs: Plastic Syringes and Blood Transfusion Sets (21-Mar-18 ECA)
Two Ph. Eur. (European Pharmacopoeia) packaging chapters have been revised and published for comment in Pharmeuropa 30.1:
The deadline for comments is March 31, 2018.
Both chapters have been revised regarding the test on ethylene oxide. A modernization of the gas chromatography method (including the replacement of the packed column by a capillary column coupled with mass spectrometry (MS)) is proposed. Furthermore, the ethylene oxide extraction step is to be adapted to the type of plastic material to be examined in order to maximize the release of ethylene oxide present.
The method has been validated and is considered suitable for the following materials:
The drafts emphasize that not all possible plastic materials under the scope of the general chapters have been evaluated so far. According to chapter 3.2.8 the most commonly used materials are polypropylene and polyethylene. Therefore, users are requested to provide data concerning other plastic materials, including, but not restricted to, polyethylene, polypropylene and non-plasticized PVC, with a special emphasis on the validation of the ethylene oxide extraction step.
Additionally, in chapter 3.2.8, the test for pyrogens (2.6.8) has been replaced by the test for bacterial endotoxins (2.6.14) following the provisions of the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes. However, chapter 3.2.6 has not yet been revised regarding the test for pyrogens. Users are invited to provide data on alternative validated methods for 3.2.6 and for the testing of sterile plastic containers for human blood and blood components (Ph. Eur. chapter 3.2.3).
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