ISPE GAMP ® 5 (Second Edition) coming soon!

Coming Soon: July 2022 

GAMP® 5 (Second Edition)

Maintaining the principles and framework of the First Edition (2008), GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of:

  • service providers;
  • evolving approaches to software development;
  • and the more widespread use of software tools and automation.

It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate qualification and validation approaches.

Read more at: https://ispe.org/publications/guidance-documents/gamp-5

OECD – Advisory Document on Good Laboratory Practice on GLP Data Integrity

OECD Environment, Health and Safety Publications Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring – No. 22 – September 2021 – released:

This advisory document was developed by the OECD Working Party on Good Laboratory Practice (GLP). The development of the document was initiated and led by the UK and included a drafting group under the leadership of Stephen Vinter (UK) and Thomas Lucotte (France Medical Products). The drafting group included representatives from Argentina, Austria (Medical Products), Belgium, Denmark (Medical Products), Italy, Mexico, the Netherlands, the US (EPA) and the US (FDA). The process included a public comment period and review and endorsement of the document by the Working Party on Good Laboratory Practice.
This document is published under the responsibility of the Chemicals and Biotechnology Committee which agreed to its declassification on 8 September 2021.

Download here

IPA Annual GMP Update 2021

About the Conference:

International Pharmaceutical Academy (IPA) is delighted to be hosting its 17th annual GMP Update | BPF Mise à jour on October 6 & 13, 2021 | Online.

This virtual conference will provide attendees with insight and a plethora of information on quality, compliance, validation, and regulatory areas affecting the pharmaceutical, biopharmaceutical and allied industries. It will address compelling issues and the current challenges of GMPs environment.

The “GMP UPDATE 2021” is the place to broaden your learning opportunities and engagement with the industry!

Attend the conference from anywhere from the comfort of your computer. This virtual event will provide participants with access to live streaming presentations, live chat and Q&A. Network with your peers on video conferencing.

Read more: https://www.accelevents.com/e/ipa-annual-gmp-update-2021

MHRA – The data lifecycle

The data lifecycle is a way of describing the different stages that data will go through, from collection to dissemination and archival/destruction. The purpose of the data and its lifecycle should be well understood by anyone who handles the data, from its collection to the eventual output.

This section of the framework describes the stages of the data lifecycle in more detail, and outlines quality issues that may occur at each stage.

Quality across the data lifecycle

Quality assessment and assurance should take place at each stage of the lifecycle. The measures used will change at each stage.

Throughout the data lifecycle, those involved should be aware of future users of the data and possible onward uses of the data, and should ensure that data quality at each stage is documented and communicated clearly.

Data practitioners may sometimes need to return to earlier stages in the lifecycle to correct data quality problems.

The stages of the data lifecycle

The data lifecycle illustrated here is not intended to be prescriptive. It is designed to illustrate the journey that data will take through most organisations and identify points at which data quality problems could happen. The actual data lifecycle for an organisation will be specific to the organisation and its processes.

Data leaders may find it helpful to use the data lifecycle here to design one for their own organisation.

Read more:

https://www.gov.uk/government/publications/the-government-data-quality-framework/the-government-data-quality-framework#The-Data-Lifecycle

PIC/S PI 041 – Final Version – 1. July 2021

We are pleased to announce on 1. July 2021 that the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force. The document marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. The PIC/S Working Group on Data Integrity acknowledges the support from professional associations across the pharmaceutical industry who contributed to a targeted stakeholder engagement exercise in 2019. The feedback received was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.

The draft guidance was first published by PIC/S in 2016 and applied by PIC/S Participating Authorities on a trial basis. Based on Members’ comments, it was revised by the Working Group on Data Integrity and then subject to a focused stakeholder consultation on specific issues (November 2018 – March 2019). The Working Group incorporated the feedback from stakeholders and submitted the final draft to the PIC/S Committee for adoption.

The Working Group continues its data integrity activities through development of training material for the PIC/S Inspectorates’ Academy (PIA) and other inspection-related resources for inspectors within the network.

To download this guidance (PI 041-1), please consult the page “Publications”.

Direct access to PI 041 final – 1. July 2021

MHRA and FDA Joint Paper ‘Data Integrity in Global Clinical Trials’

The MHRA posted the following news on their website: https://mhrainspectorate.blog.gov.uk/2020/06/30/mhra-and-fda-joint-paper-data-integrity-in-global-clinical-trials/

It says that:  “MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.”

If you click on the link below of the MHRA post you are forwarded to: https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1794

There you can buy the mentioned joint paper – starts at 7 USD for 48 hours.

We give to that simply: No comment!

Let us only add something… both agencies are members of the PIC/S and ICH.

GMP Paper 4.0 – a retrofit solution

A lot of GMP regulated companies are currently in a transition period from a hybrid approach (paper-based / electronic data storage) to paperless processes. Such projects might be named to Industry 4.0 or digitalisation, paperless lab, LIMS etc.; or might be executed as part of a Data Integrity / Data Management program to reduce manual data inputs and transcriptions.

In reality it must be mentioned that GMP records, such as batch or laboratoy records might be a summary out of 20 to 60 print-outs (attached) = data sources = computerized systems. These systems and applications might be in place since many years and may not be ready for digitalisation / automated interfaces, but do fulfill technical and compliance requirements. So it might be better and more realistic to plan an intermediate step between the “classical” hybrid approach to full digitalisation and to define realistic timelines for the final implementation. During this “extended” hybrid approach solutions might be useful which could be defined as “retrofit” approach to existing systems, because the update or total replacement of such systems might take some time.

Figure 1: From hybrid approach to paperless

CCS has developed a retrofit solution regarding the records management approach for all quality, production and laboratory records, which is called GMP Paper 4.0. In addition creating print-outs will be required also in future for regulatory purposes, so it will be a solution for the transition period and afterwards.

But what is Paper 4.0  and how can it be used:

  • Paper 1.0: Print-outs on simple office paper (format DIN A4 or Letter, 80 g/m², white)
  • Paper 2.0: Print-outs on copy-proofed paper (anti-copy paper or copy-reactive paper with hidden message or watermarks)
  • Paper 3.0: Print-outs on Paper 1.0 oder 2.0 with a QR code containing records meta-information to electronic storage, locations, authors, status etc.
  • Paper 4.0: Print-outs including an NFC Sticker / Tag (on paper, as part of the paper)

Our GMP NFC Stickers for records are qualified, can’t be removed from the record (original or copy), are definitly unique by ID numbers during manufacturing and could be fully protected against data changes. Any device with NFC can read the information of the record, verify the authenticity of the print-out and all related meta information of the record (online connection required for verifications).

Our validated GMP Records Management system (RM Manager) is used for the registration, hand-over, control and administration of all GMP records, even if such records are created by existing systems not connected to a central database.

Please contact us at talk@comes-services.com for more information.