This regulation exemplifies the Food and Drug Administration’s (FDA’s) present rational on this topic.
It does not put any rights for or on any person and does not function to bind FDA or the public. A substitute methodology may be used if such approach fulfills the regulations of the applicable rulings and guidelines.
This article is intentioned to provide direction regarding good manufacturing practice (GMP) for API manufacturing under a proper system for handling quality. It is also projected to aid in ensuring that has the quality characteristics that they claim.
The term API manufacturing in this guidance is defined to include all operations of quality control production, packaging, repackaging, release, receipt of materials, storage, labeling, relabeling, and delivery and the associated controls. A different approach may be used if such approach fulfills the requirements of the relevant rulings. The terms CGMP and GMP are equivalent for this guidance.
The article doesn’t cover security features for the workers occupied in manufacturing, and it acts as guidance only, nor to issues associated with the security of the surroundings. These controls are essential responsibilities of the manufacturer and are governed by national laws.
It is not intended to outline registration and/or filing requirements or modify medicinal requirements. This guidance does not affect the capacity of the responsible regulatory agency to institute precise registration/filing requirements concerning API manufacturing within the context of marketing, approvals or drug applications. All obligations in registration/filing documents should be met.
Materials may vary within the global community, as to their permitted cataloging as an API. When an ingredient is classed as an active pharmaceutical ingredients(API) in the country or state where it is produced or used in a drug product, API manufacturing according to this guidance.