CE Mark, GMP, GDP, and GLP Certifications
The best Compliance Certifications
Genveritas Global is the International ISO Certification Consulting Company, offering services in various countries. You can reach Genveritas Global and get guidance on Compliance Certificates such as CE Mark, GMP, GDP & GLP Certifications.
We do provide end-to-end product Certification Support. Our expertise is ISO 9001, ISO 27001, ISO 14001, ISO 45001, ISO 20000, ISO 13485, ISO 22301, ISO 22000, CE Mark, GMP, GDP, and Other International Certification Services.
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GMP, GDP, GLP & CE Mark
About Compliance Certifications
Compliance Certification is part of Business Certification, which ensures the Quality, Reliability, and Safety of the Products or Services the company offerings. Like ISO Standards, there are other standards for particular operations or to make improvements for your business. It may be manufacturing, or distribution, the quality matters in every stage of the Business Operations. In order to meet the business objectives or regulatory requirements, the organization has to follow a set of guidelines.
As a part of Compliance Certifications, you can achieve the following certifications based on your requirements,
- GMP Certification: Good Manufacturing Practices
- GDP Certification: Good Distribution Practices
- GLP Certification: Good Laboratory Practices.
- Product Certification: CE Mark, RoHS, & Ecocert Etc.
Introduction - GMP Certification
Good Manufacturing Practices
Good Manufacturing Practices (GMP) is a system that ensures the quality of products manufactured or produced. The primary aim of the GMP system is to ensure the minimization of risks involved in the productions and manufacturing of products. This system is mainly considered for food production, cosmetics, dietary supplements, medical and pharmaceutical industry.
GMP System covers all the aspects of manufacturing or production from material procurement to the final finished product. The system set the guidelines for safer premises, equipment usability, and hygiene in the process. Also, includes training and skill enhancement of organizational staff. So, overall the GMP Certification ensures the following aspects to meet the guidelines and requirements.
Benefits of GMP Certification
Introduction - Product Certification
CE Mark Certification
The European Conformity (Conformitè Europëenne) CE Mark is a Product Certification mark defined by the European Union to ensure the products’ safety, security, and quality to meet the requirements set by Union for the products sold within the EU. The CE Mark represents the declaration from the manufacturer that the product meets the requirements and comply with the EU directives.
The CE mark Certification is mandatory for the manufacturers who want to sell their products in the EU Countries. The Mark is also mandatory for manufacturers and exporters outside the EU to sell their products within EU Countries.
EU Directives: CE Certification
- Machinery Directive – 2006/42/EC
- Low Voltage Directive – 2014/35/EU
- EMC Directive – 2014/30/EU
- Medical Devices Directive – 93/42/EEC
- Personal Protective Equipment Directive – 89/686/EEC (as of 21 April 2018 replaced by the Personal Protective Equipment Regulation (Regulation (EU) 2016/425)
- Construction Products Regulation – Regulation (EU) No 305/2011
- Pressure Equipment Directive – 2014/68/EU
- REACH – Regulation (EC) No 1907/2006
- RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- ATEX Directive – 2014/34/EU
- Toy Directive – 2009/48/EU
- Radio Equipment Directive – 2014/53/EU
- Recreational Craft Directive – 2013/53/EU
- Active Implantable Medical Devices Directive – 90/385/EEC
- Explosive for Civil Use Directive – 93/15/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Gas Appliances Directive – 2009/142/EC
- Lifts Directive – 2014/33/EU
- Pyrotechnic Directive – 2007/23/EC
- Measuring Instruments Directive – 2004/22/EC
Introduction - System Certification
GDP Certification & GLP Certification
GOOD DISTRIBUTION PRACTICES (GDP)
Good distribution practice (GDP) is a quality warranty system, which includes requirements for the purchase, receiving, storage, and export of drugs intended for human consumption. It regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end-user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
The GDP Certification shall apply to all organizations involved in manufacturing, processing, packaging, storage, and distribution. The GDP certification deals with the guidelines and requirements for the medical drugs that are used for human use.
The GDP Certification shall apply to all organizations involved in manufacturing, processing, packaging, storage, and distribution. The GDP certification deals with the guidelines and requirements for the medical drugs that are used for human use. GDP Certification process evaluates implemented system based on the guidelines defined in GMP (Good Manufacturing Practices).
GOOD LABORATORY PRACTICE (GLP CERTIFICATION)
In the experimental (non-clinical) research arena, Good Laboratory Practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physiochemical properties through acute to chronic toxicity tests.
The GLP Certification is primarily applicable to pharmaceutical businesses, non-clinical animal testing institutes. Also, applicable for other activities such as color additives, food additives, food packaging, and medical devices. The GLP Certification is not applicable to Clinical Studies as clinical studies are regulated by Good Clinical Practices (GCP).