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/Q.gif) | What is a batch? |
/A.gif) | A batch is a defined quantity of a product involving all used materials from raw material to packing material. This is to ensure a homogeneous product for each batch. |
| Does Missionpharma prequalify all manufacturers? |
| Yes, we prequalify all our manufacturers. We run a comprehensive prequalification system, which is managed by our QA/QC team. All manufacturers are validated based upon specific criteria in our prequalification system and only manufacturers that meet our standards are approved. |
| Does Missionpharma hold a certificate of Good Distribution Practice? |
| Yes, Missionpharma is approved and registered by the Danish Medicines Agency as a distributor of pharmaceutical products. This approval is only granted to distributors who satisfy the regulations laid down by the Danish Medicines Agency on professional knowledge, organisation and operation. Therefore, Missionpharma conforms to the requirements for good distribution practices as recommended by the European Community. Missionpharma is inspected every two years by the Danish Medicines Agency. Download GDP certificate. |
| How do you handle a claim from a customer? |
| We ensure that all complaints from our customers are investigated thoroughly and professionally according to detailed Standard Operating Procedures (SOPs). Our investigation starts immediately after receipt of the complaint and includes a review of internal product specifications and/or product file, the quality control document and the certificate of analysis.
This is followed by re-testing of the product, using a laboratory accredited according to ISO/IEC 17025 or approved by European authorities. In a situation where the conclusion is that Missionpharma or the manufacturer has caused the product not meeting specifications, the claim is accepted without further notice. In such an instance it is ensured that the appropriate corrective measures to prevent recurrence of the problem are taken. |
| Is there a difference in quality between generic drugs from different sources? |
| Yes. There can be a significant difference regarding aspects such as choice of raw material, type of coating, shelf-life, packing and labelling. Any medical wholesaler should be aware of these differences and should be able to provide you with documentation to substantiate the quality level you require. |
| What is a Manufacturing license? |
| A manufacturing licence is an official authorisation issued by the national health authorities to a pharmaceutical manufacturer allowing the company to manufacture a certain range of pharmaceutical products according to current laws and orders. The certificate is normally issued in the local language and is generally not meant to be handed out to a third party. |
| What is a GMP-certificate? |
| A GMP-certificate is issued by the national health authorities and generally summarises the contents of the manufacturing license in one page. The certificates states:
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| Why is a GMP certificate not enough? |
| A GMP certificate itself is no guarantee for GMP compliance, as it highly depends on how the GMP regulations are interpreted by the national health authorities. Furthermore, a GMP approval does not cover the manufacturer’s capability to maintain consistency in the used API quality, in-process controls and other routines in the daily production and controls.
Therefore, in order to ensure compliance with GMP guidelines, it is of fundamental importance that on-site audits are performed. |
| What is a Free Sale Certificate? |
| A Free Sale Certificate is issued by the national health authorities for a specific product, stating that the product is for "free sale" within the country of origin. This does not necessarily mean that the product is licensed to be placed on the market in the country of origin, but that the product is of a quality suitable for being placed on the market. In other words, a Free Sale Certificate does not guarantee that the product in question is marketed in the country of origin. |
| What is a CPP (Certificate of Pharmaceutical Product)? |
| A CPP is a certificate issued by the national health authorities upon request from either the manufacturer, the customer or the authorities in the importing country. The certificate is issued for a specific product and states whether or not the product is marketed in the country of origin. Furthermore, it states that the manufacturer of the product complies with GMP and that they are inspected regularly by the national health authorities. The World Health Organization (WHO) has set up a standard format for this type of certificate and recommends that this format is used instead of the Free Sale Certificates. A CPP (WHO format) generally covers the need for overall documentation regarding the product as well as the manufacturer. It should therefore not be necessary to request any of the certificates mentioned above. The certificate is also called a WHO certificate. |
| What is a Certificate of Analysis? |
| A certificate issued by the manufacturer for every batch of a product stating the specifications and actual test results of each parameter of the monograph. The certificate should be issued and signed by the manufacturer of the product (according to the product label) and not by the supplier/wholesaler. |
| What is a Certificate of Origin? |
| A certificate stating the origin of the product, i.e. the country in which the product has been manufactured. The certificate is issued by the manufacturer or the supplier and is stamped by the local Chamber of Commerce. |
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thank you very much for sharing!
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