#GLIMS DEFINE REGISTRATION#

Specific guidance for APIs manufactured by cell culture/fermentation is described in Section XVIII (18).

This guidance covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination of these processes. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. This guidance applies to the manufacture of APIs for use in human drug (medicinal) products. 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 guidance. Within the world community, materials may vary as to their legal classification as an API. All commitments in registration/filing documents should be met. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications.

#GLIMS DEFINE REGISTRATION#

This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial requirements. These controls are inherent responsibilities of the manufacturer and are governed by national laws. The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. This document 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. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Viral Removal/Inactivation steps (18.5).Harvesting, Isolation and Purification (18.4).Cell Bank Maintenance and Record Keeping (18.2).SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELL CULTURE/FERMENTATION (18) Handling of Complaints and Recalls (17.7).Repackaging, Relabeling, and Holding of APIs and Intermediates (17.4).Traceability of Distributed APIs and Intermediates (17.2).AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS (17) CONTRACT MANUFACTURERS (INCLUDING LABORATORIES) (16) Recovery of Materials and Solvents (14.4).Validation of Analytical Methods (12.8).Periodic Review of Validated Systems (12.6).Approaches to Process Validation (12.4).Validation of Analytical Procedures - See Section 12.Testing of Intermediates and APIs (11.2).Packaging and Labeling Operations (9.4).PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES (9) Blending Batches of Intermediates or APIs (8.4).

Sampling and Testing of Incoming Production Materials (7.3).Batch Production Records (Batch Production and Control Records) (6.5).Master Production Instructions (Master Production and Control Records) (6.4).Records of Raw Materials, Intermediates, API Labeling and Packaging Materials (6.3).

Equipment Cleaning and Use Record (6.2).Documentation System and Specifications (6.1).Equipment Maintenance and Cleaning (5.2).Internal Audits (Self Inspection) (2.4).Responsibility for Production Activities (2.3).Responsibilities of the Quality Unit(s) (2.2).Mail: the Voice Information System at 80 or 30 Department of Health and Human ServicesĬenter for Drug Evaluation and Research (CDER)Ĭenter for Biologics Evaluation and Research (CBER)Ĭenter for Biologics Evaluation and Researchġ401 Rockville Pike, Rockville, MD 20852-1448

Glims define