Each manufacturer of Drug-Device combination product (e.g. Drug, device combination products like prefilled syringes, applicators of the tropical products) shall have adequate design and development activity done so as to prove the adequacy of the safety and efficacy of the product. The design and development activity is the systematic methodology, which establishes the proper design and development of the products. Many of the customer complaints and 483’s in case of the medical devices or combination devices are contributed to the improper of the design and development control activity. The design and development requirements of the product are described in ISO 13485: 2016 and 21 CFR Part 820 also.
Project Development Process & Design Control For Combination Products
The Pharmaceutical organization which manufacturers the combination products are expected to implement the 21 CFR Part 210 and 211 and 21 CFR Part 820 for their manufacturing sites of the combination products. At the end of the design Phases, the DHF is compiled and shall be presented during the audits. The DMR shall be extracted from the DHF for the routine use and the tech transfer. The requirements mentioned in the DMR shall be used to create the DHR to demonstrate the routine production and compliances. As per the requirements of the ISO 13485:2016, the medical device file shall be established. The complexity of the design procedure is dependent on the Product complexity and intended use.
The design control is the vital part as far as the Quality Management System( QMS certification) goes.
Each manufacturer of a medical device shall establish and maintain procedures to:
- Control the design of the device
- Ensure that specified design requirements are met
CAPA Management For Combination Products
To ensure that devices meet a requirement of Combination Products
- Users’ needs and intended uses
- Requirements and Specifications
- Regulatory pathway for combination products
- Can be reproducibly and reliably manufactured, serviced and/or installed.
Tools for archiving purpose of Combination Products
- Establish design control procedures
- Develop plans for Design Projects(Include interfaces between R&D and other units)
- Identify design inputs requirements and high-level specifications for the device
- Develop design outputs (to final specifications)
- Design Verification through measurement, analysis, test or inspection that all design outputs fulfil input requirements.
- Transfer outputs to production
- Design Validation that the device performs and functions as intended and as users need an expect.
- Control changes during design and development and to existing devices Document design activities in the design history file.
Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device Combination Products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4).