Frequently asked questions
Can you help us with a new registration of a cGMP Pharma Product?
Yes, our team of experts is ready to assist you and will be happy to discuss the options for submitting a registration dossier with you. Together we come to a professional, solid and compliant solution.
From which range of raw materials can we choose as a customer?
For registered medicines, the Active Pharmacuetical Ingredients (APIs) and their suppliers are recorded in the registration file. This is usually not the case for excipients or excipients. For new registration dossiers, the Marketing Authorization Holder (MAH) determines which APIs, excipients and their suppliers are included in the registration dossier.
II have my product produced elsewhere. Can you copy this identically?
An exact copy is often difficult to make (especially with tablets). There are often minor differences in the equipment available at the two locations. We can dose the Active Pharmacuetical Ingredients (APIs) and pharmaceutical auxiliaries exactly the same. But the shape and appearance depend on the machines and processes used. Generally, the production of existing drugs can be transferred via a relatively simple variation. SoliPharma has extensive expertise for performing Technology Transfers.
Does SoliPharma have a valid manufacturer's license?
Since July 2008 SoliPharma has a valid manufacturer's license under number 109061 F. This manufacturer's license has been included and published in the EudraGMP database of the European Medicines Agency (EMA).
Is SoliPharma cGMP certified?
From July 2008 SoliPharma is cGMP certified, for both production and packaging.
What does a cGMP license mean for the production of our products?
All products are produced in an environment that meets strict cGMP requirements. This guarantees that your product is produced and packaged using high-quality processes - in accordance with current GMP regulations.
Can SoliPharma perform risk assessment on elemental impurities for us?
Yes, we work together with various experts in that field and we are happy to provide such an assessment for you.
Does SoliPharma provide a (nitrosamine) risk assessment on the raw materials, excipients and primary packaging?
Of course, this is a standard part of our compliance activities.
Can SoliPharma perform a formalized risk assessment for excipients?
Yes, we can. It is even a standard part of our compliance activities.
Can you provide microbiological validation of the end products?
We can certainly provide a microbiological validation of end products. This is now a standard part of a pharmaceutical transfer.
Can you provide a cleaning validation?
SoliPharma has extensive experience in setting up cleaning validation assessments and protocols. We are also happy to take care of the implementation of the relevant validations ourselves. New raw materials are screened by Solipharma for cleaning impact and depending on the outcome, the existing cleaning validation is expanded.
How do I know if my products contain allergens?
For every product that SoliPharma develops and / or produces, the customer receives a development sheet including an allergen declaration. If you would like additional information, you can always contact your contact person.
How do I know if the quality of a delivered medicine is good?
Each drug is released by the qualified person. He delivers a batch release document in which he confirms that the medicine has been produced in accordance with specifications, as recorded in the registration file and in accordance with the cGMP regulations. The Certificate of Analysis (CoA) is the basic document for the batch release.
How often will I receive a PQR?
A Product Quality Review (PQR) is drawn up based on the data of the batches that are produced in one year. If you opt for a PQR, you will receive an annual PQR.
Can SoliPharma perform validation studies?
SoliPharma has extensive experience in conducting validation studies for both nutritional supplements and pharmaceuticals. A professional validation team of regulatory affairs experts, qualified person, specifically trained quality control experts and production experts are responsible for conducting validation studies. This applies to analytical processes, production processes and packaging processes, all in consultation with you as a customer.
Can you analyze our end products yourself?
Yes, SoliPharma has its own laboratory where numerous analyzes can be performed quickly, efficiently and correctly. If, in addition to the CoA compliance file, you need extra control, we can - in consultation with you - offer a customized analysis package.
When is a raw material released for production?
After the analyzes in accordance with E.Ph. have been approved by the qualified person and the CoA. All packaging is sampled for APIs and excipients.
What is a CoA?
A CoA, a Certificate of Analysis, is a certificate that shows the measured values of recorded parameters and thus confirms that a product meets the agreed specifications. A CoA shows the actual measured analysis results of raw materials and of the produced end product.
What happens if an OOS, an Out-Of-Specification, is found?
With an OOS, the customer is immediately contacted and the actions to be followed are coordinated in consultation. In the meantime, a root cause analysis is started.
Can you develop analytical methods for the validated analysis of defined ingredients?
SoliPharma has its own laboratory and we have experience in the development of validated analysis methods. Our own laboratory has a wide range of analysis techniques in house.
Is your production location continuously monitored for microbiological cleanliness?
Yes, we have been performing environmental monitoring for years with our own, well-trained staff.
What minimum training have your production workers received?
Our production workers are all trained in cGMP. Retraining takes place regularly. Various operators also have a Pharmaceutical Professional diploma.
Can you take over the production of a drug?
Yes, we can supervise the transfer of the production of a medicine from location A to location B, provide validations of processes and analysis methods and carry out stability studies according to ICH guidelines.
What is the minimum quantity I can order of a medicine?
That depends entirely on the validated batch size recorded in the file. This cannot be deviated from, except by requesting a variation from the competent authorities.
Which dosage forms can SoliPharma offer?
We specialize in dry dosage forms. Our expertise lies in tablets (coated and uncoated), chewable tablets, capsules, granulates, powders and dragées. However, the dossier prescribes which dosage form is registered and therefore permitted.
Can you also pack for us?
SoliPharma has the option of blister, carton, sachet and bottle.
The drug file describes which of these options are permitted.
Can you take care of the complete process from purchase to delivery?
Yes, we can provide full service for the entire process. From the purchase of APIs, excipients and packaging materials, through production and packaging to delivery in ready-to-use consumer packaging. In practice, full service also turns out to be the best guarantee for smooth processes and timely delivery.
How long does a transfer process take?
This depends entirely on the complexity of the product and process. A transfer, including the necessary validations and variations, can be completed within a minimum of six and a maximum of eighteen months.
How long does a stability study take?
A complete stability study according to ICH conditions takes 36 months and consists of three test conditions:
25 ° C / 60% rH → 0, 3, 6, 9, 12, 18, 24, 36 months
30 ° C / 65% rH → 0, 3, 6, 9, 12 months
40 ° C / 76% rH → 0, 3, 6 months
Can you serialize consumer packaging?
Yes, we are happy to serialize your consumer packaging.
Can I supply raw materials and / or packaging materials myself?
There is that possibility, but it is often more practical and convenient to have it taken care of by SoliPharma. We are happy to unburden you so that you can focus on your market.
How are raw materials and products stored?
SoliPharma has a temperature and humidity controlled and monitored warehouse with cold room for the storage of raw materials, packaging and medicines, in compliance with the GDP guidelines. The transport of medicines is temperature controlled. Pharmaceutical raw materials and packaging materials are, until released, stored under quarantine in that warehouse.
What is the delivery time?
Delivery times are given based on available capacity, availability of APIs and forecasts already delivered. If delivery reliability is important to you, we can work out a rolling forecast together with which you are assured of reserved capacity, fast delivery and a low own stock.
Can you provide the artwork?
We certainly can. SoliPharma will be happy to develop your ideas. However, your organization remains legally responsible for the text on the packaging, the label and the package leaflet.
Does SoliPharma have experience with legislation and regulations?
SoliPharma has a special Regulatory Affairs department for advice on national and international laws and regulations.
Does SoliPharma only produce for the Dutch market?
SoliPharma produces medicines for the Dutch and international market.