Implement Lean GMP Manufacturing In Your Medical Device and Pharmaceutical Production Facilities
GMP in medical device and pharmaceutical manufacturing production facilities presents the unique challenge of keeping the balance between new developments, changes, deviations, complaints and new roles on one side and lean production of medical products on the other. Our goal is to evaluate which actions are most important and determine how these can be established in order to meet compliance needs.
We provide over 20 years of international experience in the GMP manufacturing of medical devices and pharmaceutical products to provide our customers “best practice”’ solutions for this challenge.
Customized Project Management Services
Our services may include complete solutions, dependent on the requirements of our clients. A complete solution may, for example, include complete project management of the qualification and validation processes.
We also offer customized services on demand to solve special complexities as they relate to the following standards:
- ISO 13485
- US 21 CFR Part 210 and 211
- US 21 CFR Part 11
- US 21 CFR Part 820
Based on these standards, our compliance experts offer the services below to our clients.
Gap Analysis Services
Our international experts analyze your qualification and validation strategies to evaluate your needs for compliance with the various regulations which govern the pharmaceutical and medical device industries on a global basis. Based on this GAP analysis, we develop customer-designed general strategies to correct gaps found in your systems and processes, keep the compliance, and define new strategies to optimize and implement the qualification and validation strategies.
Qualification and Validation Services
Equipment qualification and process validation constitutes a large amount of work in order to comply with regulatory authorities and international standards. We offer highly-qualified experts to support manufacturers to implement and keep risk-based qualification and validation approaches in place.
We create the SOPs required for qualification for our customers, e.g. master validation plans and qualification and validation SOPs. We can write the qualification plans and execute the necessary qualification and validation activities in order to achieve compliance.
For every qualification step we offer customized templates in several languages including:
- User Requirements Specifications (URS)
- Validation Plan (VP)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Qualification and Validation Report (QR / VR)
Our vast knowledge and wide experience in this area, gained through our long-term employment in the pharmaceutical and medical device industries, is to your advantage. This is especially true of the medical device industry, where we have specialists with several decades of combined experience.
You can take advantage of complete packages for cleaning validations in the medical device and pharmaceutical manufacturing, using a risk-based approach. Our network of certified laboratories helps us in the implementation of customized cleaning validation solutions.
Pressure air, deionized water, Aqua purifcata and water for injection are utilities used in the GMP manufacturing process. The validation of these utilities is a regulatory expectation, anchored in several national and international laws.
Our international experts can design customized validation packages specifically for your company. We support you with our well-connected network of certified laboratories which have the capacity to analyze your samples.
This methodology is customized to suit your company’s needs.
Our experts can develop a risk-based approach methodology based on ISO 14664 and EU GMP Guide-Annex 1 for the qualification of clean rooms. This methodology is customized to suit your company’s needs. A package of customized SOPs can also be provided should you require this service. Experts for providing special measurements can be contracted for you.
Validation of Computerized Systems
We provide support for the validation of a wide range of applications ranging from ERPs (i.e. SAP©, Oracle©) via MES systems and LIMS to dedicated systems in analytical laboratories or on the production floor. This includes the validation strategy, the execution of the validation activities together with our clients (design specification, implementation, and verification) and all activities to keep the systems in a validated status (Change Control, Deviation Management).
Process Analysis / Optimization
GxP-CC helps your company achieve “best practice” with our team of highly qualified experts who have numerous years of experience in GMP-manufacturing. We offer you our expertise to analyze and optimize your processes. We support the creation of SOPs, sampling plans for in-process controls in manufacturing processes and offer complete manufacturing standards.
Lean Manufacturing Processes
Achieving compliance within the pharmaceutical and medical device industries may be a long and sometimes weary process. Our goal is to plan and provide useful strategies to help you attain the leanest manufacturing processes that will remain compliant for your company.
GxP-CC provides our customers with these services through our vast experience in these industries and by the execution of GAP analyses, the implementation of all necessary steps for the production process and the optimization of those steps.
Solve your GMP issues. Contact Us To Improve Your Production Facilities