Medical devices
CM Plus is a professional consultant for medical device industry. We provide GMP consulting services to industries that must comply with PIC/S GMP, EU-GMP, cGMP or QSR (US FDA) and WHO-GMP for medical devices. Regulations such as the US FDA 21 CFR Part 820, and the ISO 13485 Quality Management System for Medical Devices and ISO 14971 Risk Management for Medical Devices, etc… are to be applied.
CM Plus can help you with the design, design review, selection, and installation of facilities and equipment.
Our experienced engineers can review your facility design or develop plant designs in conjunction with main construction company(es). They will ensure that you comply with the relevant ISO/GMP/GLP guidelines and standards and can interpret them to suit your product type and the markets you supply products to.
CMP’s experienced team focused on the delivery of construction and cost management services that range from inspection and valuation to monitoring and control for any construction project. The knowledge understanding of the local regulations, we serve, gives us the ability to deliver services to our clients who value efficiency and consistency. Our service offerings can be broadly classified into Construction and Project Management.
1. From Gap Analysis to Mock Inspection
At the First step, if a new GMP like PIC/S GMP should be additionally applied to a factory in operation, the Man, Machine, Method and Material must be investigated to identify gaps or differences from the relevant GMP requirements.
CM Plus will investigate and analyze the gaps, and report to the client with a clear proposal on possible countermeasures and a road map for subsequent actions.
At the Second, a further detailed discussion should be taken place to determine the way to go. In order to facilitate such discussions, CM Plus usually categorizes the gaps into two groups, namely “hardware” and “software”, and proceeds with discussions with the client to come up with best valued solutions in favor of the client.
At the Third, according to client’s request, CM Plus will assume responsibilities for execution of engineering and construction. CM Plus will also provide the client with professional support
services to set up proper quality systems with pertinent standard operation procedures (SOP)
and GMP training courses for the personnel.
At last, CM Plus will perform a mock inspection to assure that all of the 4-Ms (Man, Machine,
Method and Material) should be made good for expected inspections by the competent authority.
2. Support to build and improve Quality Management System (QMS/PQS)
Our consultants can help clients build and reorganize quality management systems (QMS) and
pharmaceutical quality systems (PQS).
They can also propose an ideal SOP documentation structure based on sound quality assurance policies.
The service also covers documentation support, including Master Batch Records (MBRs) for making reliable and efficient release, and SOPs and other records for assuring high quality manufacturing operations.
Output:
– GMP organization,
– QMS/PQS documentation management structures
– MBRs (for manufacturing/packaging), SOPs.
3. Support to build and improve Laboratory Control System
The service covers support for building a wide range of quality assurance systems, including management of samples/reference standards/reagents, validation of analytical methods, and qualification/ maintenance/calibration of test equipment.
Output:
- Certification system;
- Qualification documents for test equipment;
- Sampling procedures;
- Laboratory layouts,
4. Proposal to improve facilities and equipment designs
From the viewpoint of GMP, our consultants review clients’ facilities layouts, cleanliness zoning, and flows of personnel and materials to propose measures for improvement.
This service covers support for drafting of Validation Master Plans (VMP) and other related documents based on the risk-based analysis, and guidance for implementing DQ/IQ/OQ including review and guidance for execution and record keeping. This ensures that validation is implemented smoothly and without redundancy.
We also offer consultation services to support the implementation of CSV and ER/ES (CFR Part 11) based on the Guideline on Management of computerized system set forth by the Ministry of Health, Labor and welfare, and Good Automated Manufacturing Practice (GAMP), including latest debates and trends.
Output:
- VMP (for facilities and equipment);
- IQ/OQ protocols, procedures, records, plans, reports;
- CSV & ER/ES design policies
