Registration & Memberships
As a pharmaceuticals manufacturing facility Sastel Pharmaceuticals was registered in 2006 with the South African Pharmaceutical Council and the Department of Health as a pharmaceuticals manufacturing facility. Sastel is also a member of the Health Product Association (HPA) to help them to keep track of regulations and with Sastel’s client requirement and market related aspects. Sastel employs a pharmacist, which is registered as its Responsible Pharmacist with the SAPC. Today, Sastel have a deputy pharmacist and three registered pharmacist assistants to support the Responsible Pharmacist.
After some time, the building was renovated to implement the logic flow as required by GMP. More air-conditioning and a HVAC system were also installed. Customised software were developed and implemented to accommodate, regulate and control documents and processes for GMP. From a product batch number all information of the product including manufacturing conditions, operators involved and specific API’s with batch numbers and CoAs can be traced.
In the beginning of 2010 a Quality Management System was implimented. In October 2010 Sastel achieved certification in a QMS (ISO9001) and expanded it to certification in a Environmental Managed System (ISO14001) and Occupational Health and Safety Management System (OHASA18001) to form a Integrated Management System (IMS).The Quality Assurance Manager is responsible to maintain and upgrade the IMS. Three Quality Control Inspectors execute the standards and requirements of the IMS on the production floor. Sastel also employs other professionals, i.e. ingenieur, pharmacists, micro biologist and cosmetic scientists, who assist in the running of the pharmaceutical manufacturing facility and contribute to the expertise offered for the manufacturing and production of a wide range of products. (sampling.jpg)
Safety & Efficacy
Among the most important elements in any business relationship are trust, stability and confidence. Sastel is proud of its many years of manufacturing excellence. Its history exemplifies a commitment to our business partners based on these important attributes, now and into the future.
The Directors are committed to keeping abreast with national and international standards and job creation.
The underlying principles employed on all projects are to use environmentally acceptable components to improve the life of the individual, protect the eco system and to provide simple and cost effective solutions.
Development & Packaging Quality and safety
The development team keeps up to date with international quality trends and equipment to ensure that our quality can be compared with the best.
Sastel Packaging's priority is safety, quality and efficacy.
Sastel Packaging understands the importance of superior quality when it comes to nutraceutical and critical packing.
Our dedicated staff receives rigorous training, and we strive for perfection in our operations.
We adhere to strict ISO and Food Safety Guidelines, and are in the process of attaining formal FSC22000 certification.
Our QC ensure that all our raw and packing materials are only procured from reputable suppliers and undergo thorough checks before being used in products. Fourier Transformation Infrared (FTIR) samples of all our raws are taken and compared to the electronically as well as physical versions in the libraries. It will only be used if it has proved to be free of any contaminants or illegal substances.
All our packaging is tamper-evident – jars are induction sealed, and optional neck or full shrink sleaves provide additional tamper evidence.
We maintain meticulous records to ensure full traceability, and keep retention samples of all batches of finished goods.
Our developement team keep up to date with international quality trends and equipment to ensure that our quality can be compared with the best.