5 Top Tips on Managing Outsourced Activities

Article By Michelle Yeomans, EPiC Operations Manager

Most companies outsource when they do not have the resources or expertise to perform an activity or task, much in the same way as you may call in a tradesperson to do home improvements when you either do not have the time or the DIY skills to do the job yourself. In delegating the activity, it is important to remember that the company outsourcing remains responsible, so it needs to have a robust supplier management system in place to select and monitor the performance of suppliers undertaking any outsourced activities. 

Here are our top tips for implementing appropriate due diligence for managing outsourced activities to avoid misunderstandings that could result in a product or operation of unsatisfactory quality: 

1. Establish and implement a circular supplier management system – You are trusting your suppliers with your business reputation and although they are not employees, a good supplier management system should follow similar steps to a HR performance management process from initial selection (recruitment shortlist), assessment (interview and assessment exercises), agreement of requirements and standards of work (Job description and written contract), monitoring of performance (regular 1:1s and feedback) and periodic review (performance review against objectives) to maintain oversight and ensure compliance and quality. 

2. Meaningful contracts – The phrase “the devil is in the detail” is often used to mean that although something may seem simple, the details can be more complicated and likely to cause problems if the requirements, responsibilities and specifics of the outsourced activities are not adequately defined. Contracts should therefore provide clear details of the delegated tasks, duties and functions between the parties. As a minimum they should confirm which products or service the contract relates to and the required standard of service, but should also consider the process for notification of changes, permission to audit, requirements for periodic review, and reference to further subcontracting to ensure this does not happen without the contract givers knowledge and approval. Contracts often include a table to summarise respective responsibilities using a tick or cross to show who is responsible for specific tasks, but to avoid ambiguity the table needs to include sufficient detail to break down specific activities where both parties have responsibilities under a given topic area. 

3. Involve technical experts in the supplier selection process –  the supplier must have adequate premises, equipment and facilities, experience, knowledge and personnel to be able to successfully carry out the activity or task being outsourced. Technical experts should therefore be involved in specifying the detailed requirements of the activity or task being outsourced, and equally there needs to be someone with appropriate technical knowledge to be involved in contract negotiations on behalf of the supplier. This is to ensure full disclosure and consideration of relevant information to enable potential hazards to be assessed and facilitates visibility of contract requirements at an operational level e.g. embedded in project specific work instructions, to support compliance with contractual requirements and prevent unauthorised changes that may have an adverse effect on the quality of the outsourced task or activity.    

4. Project specific performance monitoring – having selected a supplier for your outsourced task or activity, a project specific strategy for risk-based performance monitoring should be implemented. Even if you are using a supplier that has been used before and is already on your approved supplier list, you should still consider whether any additional or interim performance monitoring may be required based on the risks associated with the new project or task being delegated.     

5. Assessing records and results – Whilst a robust supplier management system can give confidence in a suppliers technical ability, it is equally important to consider the output of their work by assessing the associated records and results to ensure outsourced tasks or activities have been performed in accordance with the contract and meet regulatory expectations. As ex MHRA Inspectors, we have seen numerous examples where certificates, service reports, and documentation packages have been filed with no evidence of review to check the data and confirm whether the results are acceptable. It is therefore essential that assessment checks are documented to confirm the outcome and stipulate any required actions. Any required follow-up can be addressed directly with the supplier or as part of regular feedback meetings to discuss performance against objectives and to identify and resolve issues.      

Our top tips will hopefully help you and your suppliers to implement a proactive and collaborative approach to outsourcing, encouraging open and frequent communication to build partnerships and avoid misunderstandings that could have a negative impact on patients and business success. 

Get in touch if you what to know more about how we can help improve your supplier management process by assessing and advising on the effectiveness of your current process, performing due diligence audits, or provision of training to develop in-house expertise to perform supplier selection, qualification, and performance monitoring activities.  

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com 

“Transform Your Training”-5 Top Tips for Implementing an Effective Training Program

Article By Vicki Pike, Operations Manager for EPiC Auditors

Training is essential in the pharmaceutical industry for several key reasons. Proper training helps maintain high standards of product quality and safety. Well-trained employees are better equipped to identify and prevent errors, ensuring that the products meet the required quality standards and are safe for patient use. Well-trained staff can perform their tasks more effectively, reducing waste and improving overall operational efficiency. Training also ensures that employees understand and adhere to GMP/GDP requirements, which is crucial for maintaining compliance.

The Eudralex GMP guide requires training for all personnel involved in production, storage, control labs, and other roles affecting product quality. This must include basic and role-specific training for new recruits, with ongoing training and periodic effectiveness assessments. Similarly, GDP mandates training for all personnel involved in wholesale distribution activities to ensure they are competent and experienced before starting their tasks. Training records must be kept, and effectiveness periodically assessed and documented.

Unfortunately, training deficiencies, such as overdue or incomplete training and failure to follow SOPs, have led to significant regulatory actions, including referrals to the MHRA Compliance Management Team (CMT) and Inspection Action Group (IAG). These issues are often part of broader systemic failures, which, although not cited directly as a training deficiency, inadequate training is a root cause or contributory factor.

During the EPiC Virtual Symposium on 28 November 2024, we held a round table discussion on GMDP training, including refresher training. Here are our top tips for implementing an Effective Training Program:

1. Tailor Training to Roles: Develop training plans specific to each job role, considering responsibilities and required experience. Use job descriptions and SOPs to identify relevant tasks and ensure everyone receives appropriate GMP/GDP training during induction and on an ongoing basis.
2. Effective Training Delivery: Choose the most effective training methods based on the role’s responsibilities. Options include:
   • reading SOPs, when awareness of the activity is only required
   • e-learning, can be used to pull out the key aspects of a procedure
   • instructor-led training (classroom or virtual), to be used when a role has direct responsibility for an activity
   • on-the-job training is best for practical demonstrations and coaching.
3. Understand the ‘Why’: Ensure training materials explain not just what to do, but why it is done that way. Understanding the reasons behind tasks helps employees remember and comply with procedures and understand the implications of errors.
4. Refresher training: Regular management reviews of the Quality System can identify adverse trends to plan topics for GMDP refresher training. Consider using real life examples of issues that have occurred at your own site for the basis of discussions and exercises, to make refresher training as relevant as possible to your teams.  Also consider changes to regulations and new legislation. Stay informed about industry trends and inspection findings from MHRA, EMA, and FDA, and use resources like blogs, newsletters, free webinars, symposia, and forums.
5. Interactive and Engaging Training: Make training interactive to promote engagement. For GMP/GDP refresher training, use a mix of shorter sessions throughout the year rather than one long annual session. Tailor training to the audience and include opportunities for questions and clarifications.

By following these top tips, companies can ensure their GMDP training is effective, relevant, and engaging, leading to better compliance and performance. 

To assess the effectiveness of training, please see our previous post EPiC Top Tips – Assessing the Effectiveness of Training

Get in touch if you want to know more about how EPiC can deliver targeted, engaging training on a variety of topics.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

EPiC Virtual Symposium 2024

EPiC proudly presents our full-day virtual symposium event featuring an esteemed lineup of former MHRA Inspector speakers.

📅Join us on Thursday, 28th November 2024, for our event;

FROM COMPLAINT TO COMPLIANT: A PRACTICAL GUIDE TO OVERCOME CURRENT GMDP CHALLENGES. 💊💊

We will explore the latest regulatory updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.

Our objective is to combine valuable insights using real-world examples and experiences from across our consortium of expert pharmaceutical consultants to provide the knowledge and offer practical solutions to overcome current GMDP compliance challenges.

For more information and to buy your ticket click on the link below;

WOULD YOU LIKE TO JOIN AN EPiC TEAM?💫

EPiC Auditors is looking to strengthen our Management Team and grow our dynamic team of GXP Consultants.

EPiC Auditors is one of the leading pharmaceutical consultancies in the UK. It provides expert GXP Auditing, mock Inspection, consultancy, and bespoke training services to the pharmaceutical industry worldwide, as well as to pharmaceutical manufacturing and clinical trial services in hospitals.

As demand for our services continues to grow, we are looking to recruit an Operations Manager and also a GMDP Senior Consultant.

EPiC is passionate about ensuring a healthy work-life balance and maintaining an enjoyable work environment, achieved through flexible working patterns. Both posts are home based but do require travel throughout the UK and overseas.

This is a great opportunity to join a team of experts many of whom are former MHRA inspectors. Our consultants bring their wealth of experience to EPiC, ensuring that our clients receive world class guidance and solutions.

If you meet the role requirements and want to be part of a team who have first-hand knowledge of regulatory inspections and compliance and are passionate about making a difference in the pharmaceutical industry, we encourage you to apply!

The closing date for applications for both posts is 14^th September 2024

5 Top Tips for Implementing Effective Quality Risk Management

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

Quality risk management (QRM) is an integral part of GMDP that strives to protect patients by applying a scientific and practical approach to decision-making for different aspects of pharmaceutical quality throughout the product lifecycle.

The ICH Q9 QRM Guideline is referenced in Chapter 1 of EU GMP and reproduced in Part III of the guide and is intended to provide guidance on the principles, and examples of tools for QRM that can be applied to different aspects of pharmaceutical quality.

Following the Revision 1 update of ICH Q9 which became effective in July 2023, EPiC have been providing bespoke training and supporting clients as they assess and update their own PQS procedures in line with the changes to make QRM activities more effective and value adding.

ICHQ9(R1) provides multiple examples of potential applications of QRM, and If you have not done so already, we recommend you review the training materials on the ICH Q9 webpage https://www.ich.org/page/quality-guidelines and follow our top tips for effective QRM:

1. QRM application – QRM can be applied anywhere there is potential risk across the business and across a product’s lifecycle. In applying QRM, it is important to ensure that patient safety and product quality considerations remain front and centre, as patients are putting trust in the decisions you make. QRM cannot be used to justify bad practice and non-compliance with GMP requirements.
2. Risk Review – Be proactive and develop mechanisms to prompt reviews of existing risk profiles and control measures as your knowledge and experience increases. For example, set aside time at Quality Management Review meetings to review risk registers, review risk assessments associated with specific manufacturing processes, perform a review of engineering activities to confirm that planned preventative maintenance is on track and equipment is performing as expected, periodically review supplier performance and changes to confirm existing risk ratings are appropriate.
3. Adopt a QA mindset – Design your processes to deliver a quality output rather than relying on problems/defects being detected at the end of the process. Provide training in the tools and techniques to the people involved in QRM activities and consider using experienced facilitators for more formal QRM processes.
4. Think about the people involved – subjectivity can directly impact the effectiveness of risk management activities and the decisions made, so it is important to be able to recognise and control subjectivity, bias, assumptions, and mental shortcuts. This can be achieved by ensuring that risk questions are clearly defined, appropriate QRM tools are applied, and by being objective and evidenced based when assessing data and proposed control measures.
5. Apply critical thinking – Critical thinking requires us to actively engage our brain to be able to work out complex problems. In working through the risk assessment, risk control and risk review phases of QRM, think clearly and rationally to understand the logical connection between ideas. Use the Q9 QRM toolkit to provide a systematic approach to identify, analyse, and solve problems rather than using intuition or instinct, but be prepared to question ideas and assumptions rather than accepting at face value e.g. is the tool fit for purpose, does the output seem right?

Effective and proactive QRM can enable better, more informed, and timely decisions throughout the product lifecycle, and we hope that our top tips will provide you with some useful ideas on how to further enhance your QRM processes.  

Get in touch if you want to know more about our bespoke QRM and critical thinking training.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com