- Are you prepared for an internal audit?
- German expansion plans postponed
- New privacy legislation – what does this mean for Bedrocan?
- Bedrocan visits Bhutan
- First results Bedromedic testpanel
- Bedrocan donates vaporizers to Czech hospitals
- Technical reinforcement for Emmeloord
- New! Bediol cream
- Yield overview Emmeloord and Veendam
Are you prepared for an internal audit?
Are you ready for the coming internal audits? No?! You’re not sure what it is? Read more, because Bedrocan conducts so-called internal audits, where we scrutinise our working methods ourselves. They will take place from today and will be carried out by our own people.
The audit will be announced in advance and will take place in accordance with the appointment. Your department will not be caught off guard. Your manager will inform you.
What is an internal audit?
An internal audit is a systematic investigation into the good and reliable functioning of the internal organization. It prepares us for an ISO audit (see below). An internal audit is always carried out by our own employees.
The following employees have been trained as internal auditor:
|Petra Amsinga||Wim Bouter||Naiem Hakiemie||Monique Jager|
|Willem Mink||Sharon Oosterhuis||Margret Westerhuis|
Could the internal auditor visit me?
Yes, in principle the auditor could visit any department, irrespective of whether you work for Bedrocan Nederland or Bedrocan International. On Thursday morning, the 12th of April, the departments that are due a visit will be decided. The managers will be informed immediately by QA Manager Wim Bouter.
Should I prepare for an audit?
You can, but you don’t have to, because in principle every employee knows his activities and actions. You have been trained and the work instructions are available in the designated places, including the QMS.
Which questions could they ask?
The conversation generally starts with the following questions:
– What type of work do you do?
– Where are your activities described?
– Can you show me the procedure?
Then the discussion continues and new questions will be asked on the basis of your answers.
An ISO audit will also take place at Bedrocan for the summer. Then an external company comes to Bedrocan to interview random employees about our working methods. Such an audit consists of two days. On the first day A2 (Veendam) is visited. The auditor(s) will visit A5 (Emmeloord) the following day.
What is an ISO audit?
An ISO audit assesses whether Bedrocan applies the international standard for quality management systems (QMS). Bedrocan has its own QMS that contains our procedures and work instructions. For example, we have work instructions for harvesting or disinfecting rooms. They also describe our management objectives or communication within the organisation. All the procedures are filed in digital format, and many are available on the work floor.
An audit scrutinises the entire QMS. The assessment will be performed by the external company BSI. During the audit, a BSI employee – also known as the auditor – will have discussions with management, but also with employees in the department. He may either observe what you do or he may interview you. This interview will be about how your activities contribute to the quality of our end product and the mutually agreed working methods.
Wim Bouter is our Quality Assurance Manager and he will make sure the audit goes well. He has three important tips for you:
1 – Answer the question, stick to the topic, don’t digress.
2 – Don’t try to make up an answer. If you don’t know the answer, just say so.
3 – Don’t be scared and don’t be nervous. The result of this audit does not have any consequences for you personally. It only charts whether the organisation as a whole is in order.
Why do we need the audit?
We need the audit to retain our ISO 9001 certification. This certification demonstrates that we reached clear agreements about our working methods, that those agreements are recorded and that it is ensured that everyone knows those agreements. This guarantees parties who wish to work together with us that we don’t just mess about, but that our processes are properly in order. In that sense ISO simply equals quality.
We already have GMP certification, surely that’s enough?
An audit for ISO 9001 certification helps us, as organisation, to consider our working methods in depth and to record those professionally. That benefits the GMP certification too. For GMP we also need to have everything in order, but it goes just that little bit further, because those inspectors want to know everything about hygiene and quality control too.
Is this a one-off audit?
No, there is an audit every six months. They are announced by your manager or in the newsletter if necessary.
What happens after the audit?
The auditor writes a report with his findings, which says whether we have our processes in order or not. If not, we are given the opportunity to amend our processes. If we don’t, we jeopardise the certification but it simply won’t come to that.
German expansion plans postponed
The German tender procedure has become subject to a delay of a few months or maybe more as a result of a court decision following complaints from a Germany company. They believed there was insufficient time to meet the deadline of the tender. The court agreed and prohibited the German Federal Institute for Drugs and Medical devices (BfArM) to issue cultivation licences.
Bedrocan – together with 10 other, predominantly Canadian companies – was in the running for a cultivation licence. The plan had been to start constructing a new facility in Bunde this year after the licence had been awarded. Following the court decision, these plans have been shelved for the time being.
New privacy legislation: what does this mean for Bedrocan?
As of 25 May 2018, the new European General Data Protection Regulation (GDPR) comes into force. As of that date, the same privacy rules apply in all European Member States. The GDPR will replace the existing Dutch Personal Data Protection Act, known as Wbp.
The law will apply to all organisations and bodies that manage, store or edit personal data. For example, Bedrocan is not entitled to save unnecessary data as employer and is only permitted to process those data that need to be processed. Besides that, there are a few more clear rules. For example Bedrocan should:
– Make clear in advance which personal data are collected and for which purpose
– Ensure correct processing of personal data
– Not keep personal data unnecessarily long and should consent to the employee’s requests for inspection, correction or removal
– Secure data and prevent unauthorised distribution (data leaks)
Wat does the GDPR mean to you as Bedrocan employee?
First of all, the GDPR provides more and improved rights to privacy protection. Every employee is entitled to inspection, correction and removal of his own personal data. A newly acquired right is that of data portability. This means that an employee is entitled to have the personal data, if required, passed on to another organisation.
As a good employer, Bedrocan strives to deal carefully with the data concerning all employees. We only process data that was acquired on a statutory basis, such as an employment contract, with individual consent or on the basis of a statutory obligation. It is good to know that the GDPR does not permit Bedrocan to ask for and collect more information than strictly necessary.
Bedrocan visits Bhutan
The government of Bhutan is looking to cooperate with Dutch researchers in the area of medicinal cannabis. Recently the first discussions were held in the Asian mountain state, attended by researchers from Wageningen University & Research (WUR), Naturalis and the University of Amsterdam (UVA). Bedrocan was represented as experienced cannabis cultivator by CEO Tjalling Erkelens and his wife Wupke Bruining.
The Kingdom of Bhutan has more than 750,000 inhabitants and is in the Himalayas, wedged in between India and China. The country is known for its enormous diversity in flora and fauna, including a significant number of different cannabis varieties. Not surprising when you remember that the eastern part of the Himalayas is known as the cradle of the cannabis plant. Unfortunately Bhutan – like India, Pakistan and Nepal – has never shared in the profits generated in Europe and the US in particular from the trade in cannabis varieties that originated in the Himalayas. However current legislation, set out in the Convention of Biological Diversity of 1993 and the Nagoya Protocol of 2014, requires that they should and this is Bhutan’s express ambition.
With the clear backing of King Jigme Khesar Namgyel Wangchuk, the government would like to study the opportunities to produce medicinal cannabis oil, compliant with the applicable quality and safety requirements, from ‘wild’ cannabis. At the same time, parties such as WUR, Naturalis, UvA and Bedrocan have a scientific and economic interest in learning which varieties occur in the wild and in learning more about the purity and stability of those varieties. A project has been set up under the name Bhutanics in which Bhutanese and Dutch parties work together to study the cannabis in Bhutan in depth on its genetics, chemical composition and opportunities for medicinal use in Bhutan.
The foundations for Bhutanics date back to 2016, when Wupke and Tjalling were invited by the Bhutanese royal family for the first discussions. According to Tjalling, this project is an excellent way to gather knowledge and materials for product development in accordance with international rules.
At the same time, it is an excellent opportunity to give Bhutan something in return by sharing knowledge and experience in the area of medicinal cannabis and to bring corporate social responsibility to life. Cooperation with knowledge institutes, such as WUR, Naturalis, UvA and even the Transvaal Pharmacy in The Hague, adds a respected and valuable scientific dimension for Bhutan.
On behalf of Bedrocan, the project team has been expanded with COO Lisette de Ruigh and botanist Hugo Maassen. The first field expedition, which will chart the cannabis varieties in different sites in Bhutan, is scheduled for the end of this coming summer, just like the first trials with production of cannabis oil in Bhutan.
To be continued!
First results Bedromedic testpanel
Some time ago, Bedrocan sent the Bedromedic, a new vaporizer, to 20 patients in the Netherlands who use medicinal cannabis. We asked those patients to complete a questionnaire about their experiences with the Bedromedic. Despite the fact that not all participants completed the questionnaire, we want to give you a sneak preview. Below you can find some questions and respondents’ answers.
Who brought up the idea to use cannabis as medicine?
What cannabis variety do you vaporize?
Which route of administration do you prefer?
- Smoking with tobacco
- Smoking without tobacco
How do you experience irriation of your lungs/coughing?
- Not problematic
- No opinion
- Not problematic, but it needs improvement
Bedrocan donates vaporizers to Czech hospitals
Bedrocan has donated ten medical vaporizers to two Czech hospitals. They concern the Volcano Medic®, and they are used in the Sint Anna University Hospital and the Masaryk Cancer Institute in the Czech city of Brno. Under the guidance of trained personnel, pain and cancer patients learn how to operate and dose the device. The Sint Anna Hospital has set up a special area for this purpose, which was put into use officially on 17 April.
The Czech Republic has had a medical cannabis programme for many years. However, as in the Netherlands, cannabis and expensive vaporizers are no longer reimbursed by health insurance policies, causing a major problem for patients with low incomes in particular. Bedrocan hopes that by donating the vaporizers, patients are able to familiarize themselves with vaporization as a method of administration before they purchase the vaporizers. Vaporizing is generally regarded as the most efficient dosage form because the active substances are absorbed quickly into the body. It is also safer than smoking because there is no release of toxic substances, such as carbon monoxide, ammonia or polycyclic aromatic hydrocarbons (PAHs).
Bedrocan has been working with one of the doctors of the St. Anna hospital, doctor Radovan Hřib, for many years. As a pain specialist, he prescribes medicinal cannabis for patients with chronic or acute pain. The special user space was his idea. Doctor Hřib commented “Now patients often have to rely on capsules that are compounded by the pharmacy, but it is not the best dosage form in pain management. Vaporizing is preferable above all else, because the vapour is absorbed immediately into the bloodstream and the effect is felt immediately.”
In addition to his work in the hospital, Dr Hřib is associated with the Czech patient organization KOPAC. In the Czech Republic he is regarded as the medical expert in the field of medicinal cannabis. He cooperates with government bodies to increase the availability of cannabis for medicinal use to the patients and to simplify administration for doctors. He was also involved with the registration of medical vaporizers in the Czech Republic. The user area with the vaporizers is intended to teach patients to dose. Doctor Hřib said “Unfortunately there is no universal dosage. Every patient reacts differently to cannabis. Here they learn which dosage suits them best. Under expert guidance, they also discover any possible side effects occur and how to deal with those.”
Technical reinforcement for Emmeloord
Emmeloord (A5) has a new employee who will support the site in the technical sphere. His name is Sjoerd Loonstra and a number of people will have met him already. Sjoerd has been engaged for a year to ensure that all the machinery and systems in Emmeloord operate properly. He will be doing this together with our own people and suppliers.
Since A5 was commissioned last year, a number of teething problems have been observed in a number of facilities. Some machines have not been commissioned yet either, and air treatment in particular leaves something to be desired in places. The cooling system that should cool the air in the air-treatment unit does not operate yet, causing the air quality in the growth chambers to be below par. Sjoerd will also reset the computer system for water treatment, the so-called water factory. Dosing of nutrients and acids, which is currently performed manually, will be automated. Finally, he will validate all the devices for the purpose of the GMP certificate.
When everything is working properly, the team will be informed and instructed and the project will come to an end. Sjoerd said that he’s been made to feel welcome and is looking forward to getting the job done together with the team.
New! Bediol cream
Recently the Transvaal Apotheek in The Hague started marketing cannabis cream alongside cannabis oil. This cream is a new dosage form for patients. It is based on the cannabis variety Bediol and is intended for treating skin conditions.
According to Arwin Ramcharan, pharmacists QA of Transvaal Apotheek, the cream was developed at the request of a dermatologist in The Hague. “I won’t mention names, but it is a dermatologist with whom we have worked before. He was already familiar with the cannabis oil we have been preparing on the basis of the Bedrocan varieties since 2015 and which he prescribes from time to time. He wanted to try out a cream based on Bediol for group of approximately 40 patients. If the trial is positive, the group of patients will be expanded. For the time being, other patients can buy the cream from us on prescription.”
According to Arwin this is responsible and justified, because with the requirements of the Laboratory of Dutch Pharmacists (LNA) and the European pharmacopoeia (manual with requirements for analysis of medicines – ed.) at hand, it was not difficult for the employees of Transvaal Apotheek to prepare such a cream in accordance with the applicable quality and safety requirements.
Arwin commented: “We have plenty of expertise and we know how this should be done in accordance with pharmaceutical rules. We prepare several types of cream on a daily basis and we are familiar with standardised medicinal cannabis and cannabis oil. In terms of composition Bediol is a good start for trying out the effectiveness of a cream. As long as you control the composition of active ingredients, it is really only a question of spreadability and preservation.”
With the cream, for which a patient pays 60 Euro (per 20 gram), a new dosage form has been added to the range of cannabis products based on Bedrocan varieties. The Transvaal Apotheek will leave it at that for the time being. “Occasionally we receive requests for capsules, but they are more difficult to make. Furthermore, it is a significantly different administration method as capsules go via the stomach where substances are broken down; it means you need to increase the dose.”
Apotheek SMA in Rosmalen, which prepares oil from Bedrocan varieties, also has a cream available for various skin conditions. However, this Cannabinoid Cream is made on the basis of CBD crystals.
Yield overview Emmeloord and Veendam
The pie charts below indicate the types of varieties that have been produced in recent weeks.