News – Page 2 – PharmaKorell

Meet PharmaKorell at the CPHI in Milan from 8th to 10th October!

As an independent German pharmaceutical consulting company, PharmaKorell has been supporting over 180 pharma and biotech companies worldwide in more than 30 countries since 2007. With a team of over 20 experts, we offer services such as quality management, import into Europe, QP certification, and pharmaceutical logistics.

Our team on site:

Dr Lucia Vitellozzi

Dr Ulrich Korell

We look forward to meeting you in person to explore mutual growth opportunities and discuss how we can best support you. Feel free to reach out via the event app or alternatively please send us a private message.

News - 09/25/2024

New requirements for lyophilisation according to Annex 1 of the GMP guidelines

On 25th August 2024, the new, stricter requirements of Annex 1 for lyophilisation came into force. These aim to minimise the risk of microbial and particulate contamination during the critical phase between the filling of containers for lyophilisation and the completion of the process.

These requirements aim to minimise the risk of microbial and particulate contamination during the sensitive phase between the filling of products for lyophilisation and the completion of the process.

The key points are summarised below:

System design and control The design of the entire lyophilisation system must be oriented towards minimising the risk of contamination. This includes the design of the transfer and loading/unloading areas, which should be configured to minimise personnel intervention. The underlying principle is that every interaction poses a potential risk of contamination.

Validation of sterilisation and hold times of the lyophiliser Sterilisation of the lyophiliser is a central aspect of ensuring product safety. The new requirements emphasise the need for thorough validation of the sterilisation process, including the determination of appropriate hold times. The validation must ensure that all parts of the lyophiliser that come into contact with the product are effectively sterilised and that sterility is maintained until the process is completed.

Risk-based frequency of sterilisation The frequency of lyophiliser sterilisation should be based on a risk assessment. This means that sterilisation should be carried out not only at fixed intervals but also with consideration of the specific risk factors associated with the production process. This risk-based approach allows for flexible sterilisation adapted to the actual needs.

Integrity of the lyophiliser The integrity of the lyophiliser must be ensured throughout the entire process. This includes maintaining a sterile state and preventing any leaks or other weaknesses that could lead to contamination. The integrity should be regularly verified and included as part of the validation process.

Airflow patterns Another critical element is the control of airflow in the areas where the lyophilisation process takes place. Airflow patterns should be designed to minimise the risk of contamination from particulate or microbiological sources. This also includes the monitoring and validation of airflow, particularly in the transfer and loading/unloading areas.

Loading/unloading The loading and unloading of the lyophiliser presents another potential source of contamination. Therefore, clear and validated patterns for loading the containers must be established. The transfer of partially closed containers, unloading of partially stoppered vials, and the use of sterile tools for these procedures must be strictly controlled. It is crucial that transfer systems ensure the required level of cleanliness to prevent contamination of partially closed containers.

Conclusion The new requirements of Annex 1 emphasise the need for comprehensive contamination protection during lyophilisation. Through careful system design, comprehensive validation, risk-based sterilisation frequency, ensuring system integrity, controlled airflow, and meticulously executed loading and unloading processes, product safety can be significantly enhanced. Every measure should align with the site's contamination control strategy (CCS) to ensure that all potential risks are minimised.

Contributed by Dr. Gabriele Wanninger, Senior Consultant and Lead Auditor at PharmaKorell.

Dr Wanninger is a licensed pharmacist and has worked for over 25 years in state pharmaceutical supervision as a GMP, GDP, and GCP inspector, and most recently for 16 years as the Head of the Inspectorate at the Government of Upper Bavaria. She has extensive experience in regulatory affairs related to pharmaceutical and medical device law, as well as in conducting third-country inspections on behalf of the EMA.

She was a member of several expert groups within the ZLG (Central Authority of the Laender for Health Protection) and contributed to international procedures of the European Commission. Additionally, Dr Wanninger has participated in several pharmaceutical projects with gtz/giz and PTB in Asia and Africa.

Since February 2023, Dr Wanninger has been working as a Senior Consultant and Lead Auditor at PharmaKorell.

News - 09/24/2024

Dr Helene Geese: Nine Months at PharmaKorell – A Retrospective

Nine months ago, Dr Helene Geese began her role as a senior consultant at PharmaKorell and has since contributed to various significant projects and collaborated with different members of the team. In this post, Dr Geese reports on her start, her integration into the company, and how she has experienced the move to Lörrach both professionally and privately.

You recently moved to Lörrach to take on your role at PharmaKorell. How was the transition for you, both professionally and personally?

Professionally, I had no difficulties. I was fortunate to be directly involved in a large project with experienced colleagues and could immerse myself intensively in the subject and exchange ideas.

Personally, it was a bit bumpy. My husband didn't have a job immediately at the beginning, and I was worried whether it would work out quickly. Naturally, it was also a challenge that we initially couldn't get a kindergarten place. But thanks to the family initiative Wunderfitz, we finally found a childminder in Weil am Rhein. Although the atmosphere was different from the kindergarten, which the children were used to with many peers and various events, the care at the childminder offered valuable personal experiences and, above all, undivided attention. Additionally, we were lucky to have wonderful neighbours who made the start much easier for us.

After a few months, my husband found an interesting position at IWB in Basel, a renowned company in the field of climate-friendly energies, which even received the "Great Place to Work" award in 2022.

In the meantime, my daughter has a kindergarten place, and my son will start school this year at an excellent school in Lörrach.

What were your first impressions of PharmaKorell when you started, and how have they developed over the past nine months?

At the beginning, I had great respect for the experienced colleagues and was unsure whether I could meet the high expectations as a new QP. But I quickly realised that my colleagues are open and approachable people who don't expect you to know everything.

I was surprised by the high level of independence required in the projects. Although it was a challenge to work independently in many areas, I appreciate the freedom this offers me. The colleagues are always available for questions, but the necessity to work independently enhances my ability to find my own solutions.

I have grown into my role as a senior consultant and have become accustomed to the company's processes, including time tracking.

You are involved in several important projects, including a new project for the primary packaging of tablets for clinical studies. Can you tell us more about your role in this project and what challenges and successes you have experienced so far?

I see this project as an opportunity to learn about a different type of primary packaging. At the beginning, all documents had to be checked for feasibility and adapted to our client. In doing so, I worked intensively for the first time with our Head of Quality Assurance, Lucia Vitellozzi. It was a great pleasure to exchange ideas with her professionally. A great success was that our client was very satisfied with our work, which also pleased me greatly.

How would you describe the working environment and corporate culture at PharmaKorell? Which aspects do you like the most?

At PharmaKorell, you are a self-employed employee. You can organise your day freely and organise and prioritise your tasks independently. It feels like being self-employed, but without the financial risk. The variety of projects and tasks makes working here very pleasant. The corporate culture is based on great trust towards the employees. Flexibility, diversity, and trust are what I appreciate very much.

How was your experience integrating into the PharmaKorell team? Were there any special moments or team activities that have remained in your memory?

I was very well received into the team. Everyone is nice and approachable, so there are no difficulties integrating. What particularly remains in my memory is our team barbecue after a big jour fixe. It's a great opportunity to unite both locations and create a relaxed atmosphere.

What learning and development opportunities have you found at PharmaKorell, and how have they helped you in your role?

I learn something new every day, which makes this profession particularly exciting. You don't stay at a certain level of development but continue to grow steadily.

How do you find the work-life balance at PharmaKorell, especially after moving to a new city?

The work-life balance at PharmaKorell is unique. The managing directors place great trust in us and let you work independently. One reason I chose PharmaKorell was that I can work less here to spend more time with my children. I like to use this flexibility to finish work earlier and enjoy time with my family. In the evenings, I catch up on work, and I am very happy about this possibility.

What advice would you give to someone considering a role at PharmaKorell?

Just give it a try! I am very happy here and glad that I took this step.

How have you found the local community in Lörrach? Have you explored the region a bit?

The people in the region are friendly, but they are noticeably different from those in Göttingen, where I lived before. We are out almost every weekend exploring the surroundings. We have already done a lot of hiking in the Black Forest, but we also like to visit Switzerland and enjoy French pastries.

Looking ahead: What are you most looking forward to in your role at PharmaKorell in the coming months?

I am looking forward to more exciting and challenging projects where I can learn a lot and to working with other colleagues and getting to know them better.

___

Image source: https://www.skymaster-paragliding.de, Photographer: Walter Wagner

News - 09/17/2024

Dietmar is retiring

Dietmar, PharmaKorell’s IT representative and team assistant, was given a well-deserved farewell into retirement at the end of June. He could have retired at the end of 2023 but chose to work one day a week during the first half of 2024 to ensure his successor had an optimal induction period. We are very grateful for his dedication and will miss him greatly. It was wonderful that he could join us for our summer team outing and that we will see him again at our Christmas dinner.

Dietmar began working at PharmaKorell in 2018. As an IT representative and team assistant, he made a significant contribution to the success of our company and our great working environment.

We took this opportunity to ask Dietmar a few questions about his upcoming retirement.

How do you feel now that retirement has begun?

I can hardly believe it yet – in the office, you are tasked with various duties, sometimes dealing with unforeseen events, and I am looking forward to some peace and quiet now.

What were your highlights at PharmaKorell?

One highlight was certainly the introduction of Projektron software. I started at PK just before Projektron was introduced and managed the project from the beginning. Other highlights include the move to the new building, the opening of the Munich office, and, of course, the after-work barbecues.

Is there something you’ve always wanted to do but never had the time due to work?

I will definitely go on a few trips with my wife and spend more time in nature.

What will you miss most about work?

Definitely my colleagues. I always enjoyed going to the office and seeing and supporting my colleagues. I will miss them.

Do you already have plans for your retirement?

I don’t have any concrete plans. A lot depends on my personal circumstances.

Are there any hobbies or interests you want to devote more time to?

We have a large garden. I will certainly spend more time there and I have resolved to do more sports. We’ll see if the good intentions hold.

Do you plan to travel?

If so, where do you want to go first?
My first trip will probably be to Cyprus or Thailand.

Thank you, Dietmar. We wish you all the best and lots of fun!

News - 07/22/2024

Successful Team Outing with an Exciting Outdoor Escape Game

Our team outing was a wonderful experience.

At 8 o’clock, we gathered at the office in Lörrach to set off for the idyllic Walter holiday farm in Freiburg-Opfingen using the company cars. Our colleagues from Munich and the Müllheim area arrived separately and joined us directly at the holiday farm.

At 09:30, we started with a thrilling outdoor escape game in the beautiful weather, which not only challenged us but also provided a lot of fun and team spirit. After about three hours with a short picnic break, we returned to the holiday farm.

The communal lunch on the terrace was a culinary delight, featuring Schäufele and a vegetarian alternative of spinach and ricotta-filled Maultaschen.

In the afternoon, an impressive vineyard safari with a regional wine tasting rounded off our day. Additionally, we heard many interesting facts about the geology of our region from our colleague and geologist Dr. Matthias Barth.

News - 06/27/2024

Congratulations to the organisers of CPHI/PMEC China 2024 on a very successful event

Congratulations to the organisers of CPHI/PMEC China 2024 on a very successful event. For us, it was also a great success with many new impressions and contacts, reunions with long-standing business partners, and many good conversations. Next year’s date is already firmly marked in our calendar! We look forward to connecting with old and new contacts on LinkedIn or WeChat.

News - 06/26/2024

Our heartfelt congratulations to the winners in the category of Leading Enterprise of China Pharma Internationalization

Our founder, Ulrich Korell, had the pleasure of attending the CPHI Celebration Awards and Networking Party on his birthday. It was a captivating event that offered an intriguing mix of ceremonial award presentations, show performances, and networking opportunities.

We would like to extend our heartfelt congratulations to the winners in the category of Leading Enterprise of China Pharma Internationalisation: Zhejiang Huahai Pharmaceutical Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd., Qilu Pharmaceutical Group Hec, Zhejiang Pharmaceutical Co., Ltd., CSPC Pharma, Humanwell Healthcare (Group) Co., Ltd., Lunan Pharmaceutical Group Corporation, Tianjin Tianyao Pharmaceuticals Co., Ltd., BrightGene Bio-Medical Technology Co., Ltd., Zhejiang Xianju Pharmaceutical Co., Ltd., Guobang Pharma Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., Hainan Poly Pham Co., Ltd., Changzhou Pharmaceutical Factory, Aurisco Pharmaceutical Co., Ltd., North China Pharmaceutical Co., Ltd., Zhejiang Tianyu Pharmaceutical Co., Ltd., Livzon Pharmaceutical Group Inc, Northeast Pharmaceutical Group Co., Ltd.

We are particularly delighted that we have been able to actively support some of these prestigious companies in their internationalisation efforts in Europe for many years. We look forward to further successes and additional China-Europe cooperation projects.

News - 06/22/2024

Our schedule for the CPHI in China next week is taking shape

Our schedule for the CPHI in China next week is taking shape. Ulrich Korell will be attending the China-World Innovation and Development Forum 2024 (20.06.2024, 9:30 – 12:00) and the CPHI Celebration Awards & Networking Party (19.06.2024, 18:00 – 22:00), as well as having dinners with existing business partners. A few meetings have already been scheduled for the CPHI in China, but there is still time in between to explore synergies and engage in interesting conversations.

Ulrich will be in China until 24.06. For meeting requests, please send a private message.

News - 06/15/2024

Visit to BrightGene Bio-Medical Technology Co., Ltd in China

Dr. Gabriele Wanninger and Dr. Silke Litzinger have just returned from their visit to BrightGene Bio-Medical Technology Co., Ltd in China. They spent four days reviewing the quality assurance measures for the construction of a new, state-of-the-art factory. This factory will produce sterile pharmaceuticals for the EU and US markets.

As quality assurance experts, Dr. Gabriele Wanninger and Dr. Silke Litzinger play a crucial role in providing advice on regulatory compliance ahead of inspections by authorities from the EU.

News - 06/12/2024

We will be attending the CPHI in China from 19th to 21st June

We will be attending the CPHI China from 19th to 21st June. Ulrich Korell, the founder and managing director of PharmaKorell, will be in Shanghai until 24th June. China is one of the most important markets for PharmaKorell.

As an experienced pharmaceutical consulting firm, PharmaKorell is the ideal cooperation partner for European companies importing pharmaceuticals or active ingredients from China, as well as for Chinese companies looking to establish a presence in the EU.

We have already assisted several Chinese firms in setting up operations in Europe. We look forward to making new contacts and the opportunity to shape the future of the pharmaceutical industry together. To schedule a meeting with Ulrich Korell, please contact us via private message.