quality & certification
At Cobeco Pharma we stand for quality. We put all the effort needed into it, to make sure that our products, ingredients and packaging meet the most stringent requirements. To be able to guarantee this, Cobeco Pharma has a quality control department that is checking every quality procedure and assures all requirements meet our quality standards for developing food supplements, cosmetic products and medical devices and packaging to be brought to market in European and outside. Besides this, Cobeco Pharma is member of various associations and is working according to quality assurance system principles.
Natuur & gezondheidsproducten Nederland (NPN)
Cobeco Pharma is a member of the Dutch trade organisation Natuur & gezondheidsproducten Nederland (NPN). This organisation and its affiliates stand for the promotion of quality and safety in the field of food supplements.
Nederlandse Cosmetica Vereniging (NCV)
Cobeco Pharma is a member of the Dutch Cosmetics Assosiation called Nederlandse Cosmetica Vereniging (NCV). The NCV is the official trade organization of manufacturers and importers of cosmetics.
Keuringsraad – KOAG KAG
The Dutch Inspection Board, on behalf of the Foundations (KOAG) and (KAG), supervises public advertising of the healthcare and pharmaceutical industry
Cobeco Pharma is a member of SEDEX, a non-profit membership organization dedicated to creating improvement in responsible and ethical business practices in global supply chains. SMETA (Sedex Members Ethical Trade Audit) assesses a site based on their organization’s standards of labour, health and safety, environment and business ethics.
ISO13485 is an international standard and a quality management system in accordance with which Cobeco Pharma operates and that manufacturers, suppliers and distributors of medical devices can meet to demonstrate compliance with legal requirements related to medical devices. An ISO 13485 certificate is issued by an independent, impartial and expert certification body. NSAI conducts an annual assessment to check if Cobeco complies with the requirements of the ISO13485 standard in respect of the scope of the Manufacturing and Distribution of Personal lubricants.
Hazard Analysis Critical Control Points (HACCP)
Hazard Analysis Critical Control Points (HACCP). Cobeco Pharma pursues a quality assurance policy based on the Hazard Analysis of Critical Control Points (HACCP). The entire production process is being monitored to detect potential food safety dangers by the HACCP system. Unlike other European countries, the Netherlands doesn’t have a special notification portal for food supplements. For a safe food production process, all food and feed companies must have a food safety system based on the HACCP system. The Netherlands Food and Consumer Product Safety Authority (NVWA) checks, the availability and compliance of a HACCP system at Dutch companies. We could assist in notifying your private label food supplements in the notification or registration portal for the designated country.
Good Manufacturing Practice (GMP)
Products have to be produced in accordance with strict requirements. These requirements are called the ‘Good Manufacturing Practice’ (GMP). Cobeco produces in accordance with the guidelines of GMP. Our staff is especially being trained to produce our products in accordance with the high standards of GMP. Because of that, there have been a quality control system and a specially designed manufactory.
Cosmetic Products Notification Portal (CPNP)
Cosmetic products are submitted to the Cosmetic Products Notification Portal, to increase the safety of cosmetic products and strengthen market surveillance.
Certificate of Analysis (COA)
A certificate of analysis shows important specifications for a specific batch.
What’s in a COA?
- Viscosity: The viscosity of a fluid is a measure of its resistance to deformation at a given rate. A higher viscosity means a thicker fluid. We can also conduct this measurement in-house so we can check if the batch complies with our specifications.
- pH-value: An important aspect of lubricant and cosmetics is the pH value. Our products have to comply with these values so that the pH value is equal to that of the skin and the intimate area. For example, the pH specification for the Cobeco lubricants is pH 4.5 to 5.5 with pH measurements per lube ranging from pH 4.8 to 5.1.
- Microbiological test: For each batch, we conduct a microbiological test. This means we check if this batch isn’t contaminated with microorganisms.
Besides this, the COA mentions density, ingredients and appearance.
Product Information File (PIF)
The product information file is a cosmetic product dossier containing the most important information about the cosmetic product. For example ingredients, packaging, claim substantiation, and labelling. The PIF shows the product characteristics, its safety and efficacy. Each cosmetic product placed on the EU/UK market needs to have a product information file according to the EU Cosmetics Regulation 1223/2009.
A PIF also contains information about the challenge test which is performed to determine the shelf life of a product after opening and the product does not show a risk of microbiological contamination.
Safety Data Sheet (SDS)
A Safety data sheet provides useful information on chemicals and products falling under the CLP regulation (Regulation (EC) No 1272/2008). Products with one or more warning statements have to be accompanied by an SDS.
Information Data Sheet (IDS)
An Information Data Sheet is a document that holds the relevant information regarding the safety. It is intended to provide professional users with information regarding safe storage and transport. It includes information such as physical data, storage, disposal, protective equipment, and spill-handling procedures.disposal, protective equipment, and spill-handling procedures.
The purpose of stability testing cosmetic products is to ensure that a new or modified product meets the intended physical, chemical and microbiological quality standards as well as functionality and aesthetics when stored under appropriate conditions. Carrying out a stability test for cosmetics is an obligation according to the Cosmetics Regulation, EC 1223/2009.
The human repeat insult patch test (HRIPT), which is the standard human clinical test used for personal care and pharmaceutical products, is used to help predict the likelihood for induced allergic contact dermatitis (ACD) of topically applied products. Under highly controlled conditions, small amounts of test product are applied to patches, which are then repetitively applied to the backs of volunteers under the supervision of a dermatologist.
Cytotoxicity tests are designed to determine the toxicity to cells of the test subject.
Vaginal irritation test
The test item is applied topically to the surface of a human reconstructed vaginal epithelium to obtain human-relevant data on the vaginal irritation potential of a product or ingredient, without the use of animals.
The test evaluates the compatibility of the product with latex condoms analyzing any variation in the mechanical resistance to traction and bursting following contact with a personal lubricant.