GMP-Q7 / API / WHO / EXCIPENT
- WHY TMC
- We help people in pharma organizations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
- We offer a wide range of highly praised and respected ‘live online classroom and online training courses and also provide our global pharma clients with consultancy support.
- What is ICH Q7 guidelines?
- The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
- Q-7, API-GMP guidance on the good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It also aims to help ensure that APIs meet the requirements for quality and purity.
- Regulatory Applicability
- - Within the world community, materials may vary as to the legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide.
- Scope
- - This Guide 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. This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes.
- What are the 5 elements of GMP?
- 5 Main Components of GMP
- • Products. The primary materials (or raw ingredients) used to create a medical device or other relevant solution need to be of the highest quality. ...
- • People. Hiring well-qualified people will encourage GMP compliance as well.
- • Processes...
- • Procedures.
- • Premises.
