Quality Assurance Services
1. Build QMS for Agency & Industry
We have the experience & expertise with which to help Agencies and industry build a comprehensive and robust QMS that is recognised by international regulatory agencies expectations. This can be built anew or bring your current system into compliance.
With a detailed working knowledge of WHO, EU, US FDA, PIC/S directives and regulations we are positioned to provide cost effective and optimal solutions to your processes. We can provide technical document writing services and help write your procedures and work instructions that are intuitive and easy to use.
2. GxP Training
Our consultants have the knowledge and expertise with which to design and present tailored GxP education training programs to employees at all levels in a pharmaceutical manufacturing facility for drug products, active pharmaceutical ingredients, biotechnological products and medical devices.
Our GMP training programs will be designed to meet your specific requirements whilst ensuring compliance to your local and international regulatory agency requirements. We also consider the nature of your business & state of facilities; your employee knowledge and the markets to which you supply your products in designing our bespoke training packages.
We provide consultancy, audit services and comprehensive GCP training to assist and enable compliance with GCP standards as embodied in ICH E6. Our GCP training services provide participants with a solid foundation in the concepts of GCP / Helsinki declaration, Monitoring and Auditing Clinical Laboratories, GCP for Investigators, Monitors and site staff.
We offer a comprehensive training session on WHO, USP and EU Good Distribution Practices (GDP) Guidelines on good distribution and legal requirements under which Wholesale Authorisation holders must manage their Licence.
This training is designed to offer a practical explanation of the guidelines and introduces the new Falsified Medicines Directive implemented by international regulatory agencies and the EU and PIC/S as well as providing an insight into the management of quality systems and the supply chain from sourcing to final delivery.
The training provides participants an Understanding of the regulatory requirements and challenges that confront manufacturers, distributors/wholesalers and transport/logistics companies in the management of the full supply chain from sourcing to final distribution. In addition, participant will better understand the Guidelines on GDP and the expectations of the regulator; identify the controls necessary to ensure compliance along the GDP Supply Chain.
3. GMP Gap audit
We can conduct an onsite audit of your facility in-order to determine where, if any, gaps to cGMP compliance. We will work with you to define, plan an effective road map and generate realistic improvement plans with which to design and implement cost effective solutions with which to improve your processes, documentation, and operations.
We also perform Supplier Audits on behalf of clients and routinely provide expert resource to conduct audits of client suppliers, which covers API, packaging and manufacturing sites. In addition, we help our clients design vendor qualification programs, perform vendor audits and assist in creating remedies when suppliers are unable to meet their obligations or comply with the terms of a Quality Technical Agreement.
4. GMP Compliance assessment for International Agency Inspection
We can also help you obtain approval from international regulatory authorities (including FDA, EU, PIC/S and WHO) and including requirements guiding computer systems and IT data security in a GMP environment.
We can conduct pre-inspection audits of your sites, prepare remedial action plans and provide the required support to your team before and during such international regulatory authority inspection. Post inspection, we provide robust support to resolve CAPAs and help prepare any responses to the inspection.
5. Aseptic process systems comprehensive design and implementation
We have the expertise and experience with which to develop comprehensive designs for facilities, equipment, and personnel required for aseptic processes within pharmaceutical manufacturing. In addition, we can develop and manage the program to implement and validate the aseptic process, including training in good aseptic practices.