Proper documentation is essential in almost every aspect of the pharmaceutical industry. Whether for product registration, factory inspection, or internal quality control, AdvaCare employs the latest technologies to streamline and process information. All facilities possess up-to-date Good Manufacturing Practice (GMP), CE, TUV, and/or ISO certificates that reflect high quality standards and WHO rules and regulations. Essential product registration documents, such as the Certificate of Pharmaceutical Product (COPP), Free Sales Certificate (FSC), Certificate of Origin (COO), and Marketing Authorizations are among the many documents our registration department frequently submit for registration purposes. Likewise, technical files are repeatedly checked for consistency and accuracy for both internal quality control purposes and in preparation of inspections.
AdvaCare is highly specialized in the export process and has vast experience with documentation for product registration. Our customers realize the value in registering our products - the value of quality, time, and reliability.
The Good Manufacturing Practices are regulated to ensure that recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling meet or exceed internationally recognized standards and follow WHO protocol.
CE Certification and markings for medical supplies and medical diagnostic tests reflects that such products meet EU safety and health requirements. This certification also confirms that a proper quality assurance system is employed and enforced.
The ISO family of standards, enforced by the International Organization for Standardization and national standards bodies, ensures that products and facilities conform to acceptable quality management systems.
The Certificate of Analysis is the document which lists the formula for the ingredients, the amount of each raw material and ingredient, and the results of tests proving the purity of a pharmaceutical product.
The Certificate of Pharmaceutical Product states the marketing status of the product in the country of origin. It also states that the facility and product complies with GMP and regular inspections. This document is also called a WHO Certificate.
The Free Sale Certificate reflects that the quality of a product is suitable for being placed on the market, but does not guarantee that the product is necessarily marketed in the country of origin.