Our GMP ICH Q7 Consultant will provide you total support to achieve API Good Manufacturing Practices - GMP certification, in accordance with ICH Q7 requirements, in a quick, efficient and cost saving way. If you are an API (Active Pharmaceutical Ingredients) manufacturer in the pharmaceutical industry, GMP ICH Q7 Certification will ensure that the products you manufacture are consistently produced and controlled according to the quality standards and good manufacturing practices and there is no chance of contamination in your products.
GMP ICH Q7 Certification is a Good manufacturing practice certification for active pharmaceutical ingredients in pharmaceutical sector. This certification is issued by an accredited certification body upon compliance with the GMP ICH Q7 Standard. This standard provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. For the purpose of GMP ICH Q7 Certification, API manufacturing includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. GMP ICH Q7 Certification applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this certification.
Punyam.com, a leading GMP Consultancy in India, is having vast experience in the implementation of GMP ICH Q7 in active pharmaceutical ingredients (API) manufacturing companies. Punyam implements the GMP ICH Q7 certification consultancy for its clients in the following manners: