Research & Development
Formulation DevelopmentThe formulation pharmacists/scientists at the Research and Development (R&D) facility undertake each New Product Development and Product Improvement Project with the commercial product in mind. A systematic, scientifically sound approach is used, based on the principles of Quality by Design, as outlined in the International Conference on Harmonisation guidance document on Pharmaceutical Development (ICHQ8). Through the manufacture and evaluation of laboratory- and pilot-scale trials, the team develops and optimises formulations and manufacturing processes which are effective, robust, and fully amenable to scale-up, with due consideration for critical raw material attributes and critical manufacturing process parameters. In order for this to be achieved, preformulation activities, such as pharmaceutical feasibility studies to assist in dosage form design and drug-excipient compatibility studies to aid in the selection of excipients, are first conducted. The R&D pilot plant is adequately equipped to conduct trials for liquid, semi-solid and solid oral dosage forms. After commercial registration of products, the team is also responsible for product/process optimisation, process scale-up and technology transfer.
The department offers dosage form expertise for:
• Tablets and capsules
• Parenteral products
• Oral solutions and syrups
• Ointments and creams
• Complementary products in various dosage forms
Analytical DevelopmentAnalytical Development is focused on assisting with the product development cycle. The analysts in this team develop and validate analytical methods for pharmaceutical products, thereby supporting the formulation and process development for New Product Development and Product Improvement Projects. The World Health Organisation (WHO)-accredited laboratory utilises some of the most advanced scientific equipment available, such as UPLC/HPLC, GC, IR. Having this advanced capability in-house, results in fast and reliable, scientifically sound results.
Analytical Development services include:
• Method development and validation
• Analytical method transfer
• Cleaning method development and validation
• Comparative dissolution testing
• Forced degradation studies
• Specification development
• Stability monitoring according to the ICH guidelines
Release and Stability TestingAnalytical testing for the batch release for commercial products can be performed at the R&D facility. Long-term stability testing at intended and accelerated storage conditions can be conducted as per the ICH guidelines for commercial batches. Fully qualified walk-in stability chambers are available for storage at a variety of temperature and humidity conditions, as well as light (photostability). The stability chambers are individually monitored by the Building Management System and are supported by a back-up generator in case of a power failure. Temperature and humidity excursions outside the preset range trigger an alert to the relevant personnel.
Quality Assurance and RegulatoryThe premises of Research & Development are registered with Local FDA authorities as good manufacturing facility. Expertise for the generation of quality reviewed regulatory documentation is also available. To achieve our scientific and technical objectives, while maintaining the highest level of quality assurance and regulatory compliance, a comprehensive Quality Management Systems (QMS) is implemented.
QMS Initiatives include:
• Corrective and preventive action
• Deviation management and change control
• Process validations
The QMS allows a feedback mechanism on processes and systems, ensuring continuous improvement on the efficiencies and effectiveness of the processes impacting the development and testing of products
Project ManagementThe R&D project manager works closely with both our Formulation and Analytical Development teams and operations staff to ensure that projects meet the crucial timelines as defined in the project plans. The project manager is responsible for managing the projects from the initiation to completion. Each project is carefully planned and tracked. Our customers (Marketing and New Business Development) may therefore be kept informed of the progress of the projects.
The Responsibilities of the Project Manager include:
• Collaboration with customers on project implementation
• Consistent and regular communication of project status to customers
• Response to customer queries and questions