The ABPI (Association of British Pharmaceutical Industry) and AAC (Accelerated Access Collaborative) launched at the end of 2021 an ‘ATMP Roadmap’ that has been created on their behalf by Ernst & Young with input from organisations such as the Cell and Gene Therapy Catapult, The Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and The National Institute for Health and Care Excellence (NICE). It is a very useful resource for anyone involved with these products.
This ATMP Roadmap is in the form of a downloadable interactive PDF and sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to patient treatment. It also signposts where differences exist between devolved nations (Scotland, Wales and Northern Ireland) or different types of ATMPs.
There are general encouragements on best practices to Engage early, Seek advice and support, Minimise complexity and Patient centricity.
If you have any involvement in ATMPs, you would be well advised to spend some time working your way through this very useful resource.
The Joint Professional Bodies (JPB) are committed to keeping in touch with the Qualified Person’s community and will be updating this page with a quarterly newsletter to share relevant updates and information about the QP eligibility scheme.
The bulletin published in December 2021 is available here.
The Joint Professional Bodies intend on hosting the next QP Symposium on the 11th May 2022 in London. More information will be provided in due course.
EXCiPACT has two core standards covering manufacturing operations (GMP) and repacking and relabeling activities (GDP). However, the excipient supply chain includes those who only transport and store the materials in a facility.
For these organisations, the GDP standard is too detailed as it includes repacking operations where the excipient may be exposed to the environment. To help transport and warehousing operations maintain high standards of excipient safety EXCiPACT has developed a focused, leaner, standard for these operations.
This is called Good Warehousing Practices (GWP).
The objective of excipient GWP is to ensure that:
• the receipt, storage, despatch, and transportation of closed pack excipients maintain material with the desired quality characteristics,
• it assures product integrity, traceability, and consistent quality,
• it avoids product contamination, and
• it ensures that appropriate records are maintained.
Since the operations in the warehouse are much simpler than those operations practised at excipient manufacturers and distributors, audit durations are likely to be shorter with many being completed in one day.
As a result, the EXCiPACT Certification fee is only €2000 for a 3-year certificate for these operations.
Below you can find the webinar held earlier in 2021 by Dr. Iain Moore – President of EXCiPACT.
July 2021 had plenty of updates in the pharmaceutical space from the World Health Organization. As part of its weekly update for members and the general public, PQG provides a summary of these below.
Back in 2020, the WHO published draft documents on ‘Good Manufacturing practices for medical gases’, ‘Good Manufacturing Practices for Investigational Products’ and ‘WHO Good Practices for Research and Development Facilities of Pharmaceutical Products’.
After the consolidation of comments received and a review of the feedback, revised versions of the three guidelines have now been published for the second round of public consultation. (check links for each draft guideline)
The deadline for comments is 31 August 2021. You can have your say by using the enclosed template.
These along with other WHO publications can be found at the WHO Medicines website under ‘Working Documents in Public Consultation’.
The need for a ‘GMP for medical gases‘ comes from increased demand for medicinal gases, in particular the use of oxygen in the treatment of patients with Coronavirus disease 2019 (COVID-19). As a result of this, the World Health Organization (WHO) Health Products Policy and Standards Department (formerly Essential Medicines and Health Products) and other departments involved in the supply of oxygen and the inspection of production sites of medicinal gases, raised the urgency for the preparation of the WHO good manufacturing practices for medicinal gases guidance text.
This guideline focuses on the production, control, storage and distribution of medicinal gases, however, it does not cover the manufacturing of medicinal gases in hospitals or at home for personal use. Despite this, the principles contained in this document may be applied in those instances to ensure that oxygen generated at hospitals or at home are suitable for their intended use and meet the appropriate quality standards.
When it comes to the draft guideline on ‘WHO good manufacturing practices for investigational products‘, the recommendations are mainly applicable to investigational products for human use; its principles should be considered in early phase clinical manufacture.
‘WHO good practices for research and development facilities of pharmaceutical products‘ is specifically applicable to research and development facilities of pharmaceutical products procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, TOT-related activities, validation, quality control laboratory activities such as stability testing and development, and validation of cleaning procedures.
The main focus of this document is to provide for GxP in the production and control of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities, where these are directly supporting.
The principles described in this document may be applied in facilities where other products, such as biopharmaceutical products, vaccines and medical devices, are manufactured.
This guide excludes whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), medicinal gases, radiopharmaceuticals and gene therapy products.
The GxP outlined below are to be considered general guides and they may be adapted to meet individual needs. The equivalence of alternative approaches, however, should be demonstrated.
This MHRA webinar will raise awareness of the threat of stolen medicines being re-introduced into the regulated supply chain.
The event will be delivered by GDP Inspectors with expert knowledge of the issue and the capability to offer practical advice on steps the audience can take to protect themselves and patients from the threat and how to report suspicious activity.
This MHRA webinar is targeted at but not limited to: Wholesale dealer authorisations holders, Brokers, Responsible Persons and Quality Assurance personnel associated with wholesaling medicines.
To register for this free webinar use the following link.
July has been a busy month with plenty of updates from PIC/S.
At the beginning of July 2021, PIC/S published the guidance on ‘Good Practices for Data Management and Integrity in regulated GMP/GDP environments’ (PI 041-1) following three drafts, the last being in November 2018.
It is understood that at the same time two aide memoires were also published for regulatory inspectors only – one generally on the ‘Inspection of Data Management and Integrity’ and one on the specifics for chromatographic data systems.
Later in the month (on 15 July), PIC/S published the recommendation on ‘How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management’ (PI 054-1) and ‘COVID-19 RISK ASSESSMENT FOR NATIONAL ROUTINE ON-SITE INSPECTIONS’ (PI 055-1).
(PI 054-1) “… provides practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s pharmaceutical quality system (PQS) in relation to risk-based change management. It covers all relevant steps in the change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks. It indicates within each step the aspects that render the PQS to be effective in that area.”
Given this, it makes sense for you to use it to assess your own change management process before your next inspector does so!
The Purpose section provides some useful reminders of the GMP requirements for an effective PQS incorporating GMP and Quality Risk Management (QRM) generally and for a change management system in particular. It also notes that QRM is a key element of ICH Q10 and that a mature risk-based change management within an effective PQS is essential to enable greater regulatory flexibility in the reporting of post-approval changes under ICH Q12.
The checklist component of the document takes up just over three pages and follows the change management lifecycle:
• Proposals (determination of when a change is needed, including a non-limited list of common lifecycle factors that trigger change);
• Risk Assessments;
• Planning and Implementation;
• Review and Effectiveness:
o Prior to change closure;
o Prior to or after change closure, including closure of any post-implementation actions.
The checklist is worth working through in detail, but a few highlights include:
In line with ICH Q9, there is allowance for the level of risk associated with a change to drive the formality and complexity of the documentation. Consideration of current process knowledge and the product/facility lifecycle is flagged. “At a minimum, changes should maintain or improve product quality and/or patient safety, and should not increase process variability.” The data needed to demonstrate effective implementation of the change should be pre-defined in change planning and confirmed on review.
Regulatory filing implications need to be addressed.
Prepared by the PIC/S Working Group on Inspectors Safety, PI 055-1 is a risk assessment template intended to be used by inspectors, in conjunction with host sites, during the planning phase of announced GXP inspection of national sites.
It is expected that the site confirms that the necessary measures identified in the risk assessment will be implemented.
It is also noted that consideration should also be given to Covid testing of Inspectors pre and post inspection and that this may be requested by some sites. There should be two-way communication between inspectors and sites of any positive Covid test of involved personnel within the inspection window.
It is worth looking through all elements of this document and it would form a good template for any third-party audits you conduct, if you do not already have a risk assessment for these in place.
From a host site perspective, note that meeting rooms should be of an appropriate size to maintain social distancing with the number of hosts present within the same space and interacting directly with the inspector limited; if larger numbers of attendees are required then aim for participation via remote technology. Rooms should be well-ventilated, with working surfaces should be disinfected regularly.
“If any of the company personnel do not co-operate with the requests of social distancing and the additional current government guidelines or become uncooperative to the NCA personnel, the inspector will leave the site immediately”, which is clearly something to be avoided!
PQG is the longest established of the CQI’s special interest groups, which for over 30 years has met the needs of quality professionals within the pharmaceutical industry.
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On 23 Apr 2021, EMA published an important addition to their GMDP Q&A with the publication of ‘Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs’.
The document highlights that, whilst GMP certificates are not required for manufacturing and testing sites of starting materials for ATMPs, it is mandatory to comply with the ‘principles of GMP’.
The first Q&A covers the definition of starting materials.
Q&As 2-5 then go on to explain further what is meant by ‘principles of GMP’ for different types of ATMP manufacture. The application of a risk-based approach is expected to determine the risks presented by each material to quality, safety and function, thus determining the appropriate GMP controls and other mitigation measures.
The final two Q&As reinforce that this is an obligation of the ATMP manufacturer and confirm that a qualified person is not required for the production of starting materials.
Hot Topics Meeting with the MHRA and Industry Experts – 16th March 2021.
The presentations shown at this meeting are available from the ‘Members Only’ area. Please remember to login to access.
Questions received from attendees have been submitted, and answers will be posted as soon as available.
The MHRA has published further guidance in relation to supplying medicines and medical devices after the end of the transition period.
On medicines we have the following updates:
On medical devices:
In addition to this it worth noting that DHSC has launched the new DaSH portal and published updated guidance on the reporting requirements for medicines shortages and discontinuations. The guidance is available here.
GDP monographs will be the main topic of the webinar presented by Phil Butson (PQG) on Tuesday, 27 October.
The live webinar (GDP Requirements and the ECA/PQG Good Distribution Practice monographs) will be held on behalf of Pharmaceutical Quality Group as part of MP’s Digital Week.