Drug Management and Development
Adcock Ingram’s Research and Development (R&D) site is one of 24 Quality Control laboratories in the world (one of two in South Africa and one of six in Africa) to have received World Health Organisation (WHO) Pre-Qualification accreditation. This is an achievement we have attained by maintaining a high standard in all processes from inception to completion.
In addition, Adcock Ingram’s R&D site was the first stand-alone R&D site in South Africa to secure Medicines Control Council (MCC) accreditation for the manufacture and testing of pharmaceutical products for human consumption. During 2012, the facility received FDA site acceptance.
The R&D facility offers the following services:
The R&D facility offers the following services:
The 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. The department offers dosage form expertise for:
Analytical Development
- Tablets and capsules
- Parenteral products
- Oral solutions and syrups
- Suspensions
- Ointments and creams
- Complementary products in various dosage forms
Analytical 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. Analytical Development services include:
Release and Stability Testing
- 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
Analytical 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 pre-set range trigger an alert to the relevant personnel
Quality Assurance and Regulatory
The premises of R&D are registered with the Medicines Control Council as a current Good Manufacturing Practices facility. Expertise for the generation of quality reviewed regulatory documentation is also available. QMS Initiatives include:
Project Management
- Corrective and preventive action
- Deviation management and change control
- Qualifications
- Process validations
The 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 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
R&D Fundamentals
1. From concept to consumer
Innovation is pursued by Adcock Ingram's RD&l with dedication and inspiration. We're constantly transforming intellectual ideas from the boardroom, through scientific development and verification, to ensure consistency in the end product. Ultimately we aim to achieve the desired therapeutic effect in our consumers.
Innovation is pursued by Adcock Ingram's RD&l with dedication and inspiration. We're constantly transforming intellectual ideas from the boardroom, through scientific development and verification, to ensure consistency in the end product. Ultimately we aim to achieve the desired therapeutic effect in our consumers.
2. Protecting the Brands
Adcock Ingram's RD&l consistently evaluates our recognized and succesfull brands to contnuously improve on formulation design. we hereby protect not only our market share and consumer acceptance but also product integrity.
Adcock Ingram's RD&l consistently evaluates our recognized and succesfull brands to contnuously improve on formulation design. we hereby protect not only our market share and consumer acceptance but also product integrity.
3. Quality innovation and technology
Adcock Ingrams' RD&l endeavours to maintain quality in personnel, processes and products by constantly striving to innovate whilst embracing and adopting advannces in technology.
Adcock Ingrams' RD&l endeavours to maintain quality in personnel, processes and products by constantly striving to innovate whilst embracing and adopting advannces in technology.