The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards.
The cGMP Injectable Product Manufacturing process is generally the primary place where fibers, dust, rubber, shards, metallic flakes, and silicone may enter into Injectable and other Drug Products.
In December 2021, the FDA issued new guidance for Inspection of Injectable Products for Visible Particulates to improve Pharmaceutical Quality and for inclusion in the CMC.
Compliance with these new focus points hinge upon proactive utilization Drug Development Services, effective FDA Pre-Submission, and comprehensive Regulatory Consulting.
Proactive utilization Drug Development Services, effective FDA Pre-Submission, and comprehensive Regulatory Consulting will focus on the FDA’s vital points that lead to FDA Drug Approval.
The December 2021 FDA Guidance ”Inspection of Injectable Products for Visible Particulates” emphasizes that Pharmaceutical Quality and CMC Sections effectively address the following:
- Clinical Risk of Visible Particulates as a function of route of administration
- Quality Risk Assessment
– Inherent Particulates
– Intrinsic Particulates
– Extrinsic Particulates
– Quality is to be designed into the Product and Process
- Manufacturers should not rely on downstream adjustments during manufacturing to justify a poorly designed product or process.
– Proactively addressing visible particulate risk via formal Risk Assessments throughout the entire product life cycle.
- Visual Inspection Program Considerations
- Statistical Sampling
- Training and Qualification
- QMS through out entire Product Life Cycle
- Actions to address Non-conformances
The effective, compliant, and comprehensive integration of the above FDA requirements must become the documented Pharmaceutical Product Lifecycle and Infrastructure.
Based upon industry wide experience, the fastest and least costly means to achieve these are via proactive utilization of Drug Development Services, effective FDA Pre-Submission, and comprehensive Regulatory Consulting. Collectively leveraged, this will focus on the FDA’s vital points and lead to FDA Drug Approval.
Author Information
William E. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, QMS, PMS, CSV/CSA, R&D, and CMC experience. He is a published ISPE Invitational author in Pharmaceutical and Biologics Product and Process Development and has presented and trained thousands of professionals on QbD, Design Controls, Science-Risk Based Product and Process Characterization, and Risk Management at several international conferences and numerous private corporate sessions. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to approval and launch; and audited, identified, and remediated CMC and QMS deficiencies.
Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a Regulated Life Sciences consulting group focusing on IND, ANDA, NDA, Biologics, and Medical Device regulatory services. PDG is a subsidiary of Biotech Research Group Corporation.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.
