Talking about GxP solutions, you should first understand what GxP compliance is? G×P is a blanket term that illustrates the guidelines for drugs and FDA guidelines and regulations. The x here depicts different areas of pharmaceutical companies like drug manufacturing, production, and much more.
The guidelines are nothing but a standard procedure on how you should conduct the research, how you can produce them for making more profit, and how to initiate the distribution process to reach every local medical shop worldwide.
Finally, and most importantly, it infers how you can document the details of the drug for a better and easy understanding of both the common people and medical practitioners.
Services to Look for Before Choosing a GxP Consultancy Firm
To facilitate full compliance with the guidelines laid out by the FDA, it is always easy to hire an external GxP consultancy and advisory firm to ease the said process.
Even though consultancy firms offer various services, there are still some key services to ensure full compliance with the GxP guidelines and regulations. Here are a few services which are a must-have for any GxP consultancy firm:
This is one of the key services to be offered by any GxP consultancy firm. This assists businesses in carrying out general GxP audits and other necessary evaluations and inspections.
Furthermore, GxP consultancy firms must provide businesses with necessary gap analysis, verification audits, and checks to ensure the full effectiveness of different processes.
2. Support for inspections:
GxP consultancies chosen by a business must be able to carry out mock interviews, review application conformances, provide effective front and backroom support, and evaluate the agility of an organization. The consultancy firm should also help the business review site presentation, hosting processes, and tour routes.
3. Advice on strategies:
Ensure that the consultancy firm can help out businesses organize successful meetings with health authorities and ensure effective communication with the regulators.
Also, ensure that the consultancy firm can help out with verification activities and required responses to warning letters issued by authorities.
4. Technical writing:
It is best to ensure that the consultancy firm is equipped with talented writers who can assist the business with the review of annual products, develop validation reports and protocols, audit responses, necessary SOPs as well as strategic plans, and other important technical reports.
Consulting Solutions for Every Phase of the Product Lifecycle
Moving from R&D and pre-clinical to initial stage GxP clinical production, moving to a later stage is a troublesome and lengthy process. Here, manufacturers always face difficulties in maintaining GxP compliance. They always want to offer products that are safe to use for patients.
However, even for an established brand, GxP compliance-related problems can affect product lifecycle, generate high-priced downtime, and impact their authority to provide products to patients in most crucial cases.
A faulty medical device can cost a life, so a defect-proof procedure is the foundation’s core.
That’s where MWA-consulting comes in.
MWA consulting will help you launch, scale, and sustain, no matter where you stand in the product development lifecycle. With the help of experienced engineers, they offer comprehensive quality, compliance, and validation service, along with validation services, especially to cater to the needs of life science.
They cover all the aspects including, pre-clinical production to process structure to process performance qualification.
Operational Support Services
Prescient and extensive management of tools, vendors, and processes is important. From project initiation to closure, here is a list of support services offered.
- Project Management
- Program Management
- Supplier Management
- Process Improvement
The process includes various components, each covering one or more tasks. For example, a pharma company requires premium support from tech experts to continue its product research.
Facilities & Systems
The field of life science has no place for errors. The system must proceed smoothly without any minor missteps. So, it offers integration of people, processes, and tools to ensure that the processes are running efficiently while maintaining an optimal state. It includes,
- Control and Automation
- Critical System Assessment
- Reliability Engineering
- MEP Engineering
- Process Engineering
The team has expertise and guidance to deliver insight between development and production or to upgrade facilities. They will offer their clients:
- GxP and compliance advisory and Consulting
- Laboratory services and Environmental monitoring
- Commissioning, Qualification, and Validation( CQV)
- Process and Cleaning validation
- Equipment rental and Calibration
- On-demand clean rooms
To be compliant with GxP, institutions must document, determine, and list every action made by every employee connected to its manufacturing, production, or distribution process. If you didn’t log, then it didn’t happen. This is a high risk where details matter, and here MWA consulting can help in sharing the workload.