SAHPRA Consultants, Validation, Engineering & Architecture and GMP services
Although headquartered in Melbourne, PharmOut is known for providing specialist GMP compliance, design, architecture, engineering and validation services to a wide variety of international clients as well as within Southern Africa via their Cape Town office.
PharmOut also has expertise in growing Medicinal Cannabis, drawing from our pool of international experts based in Northern America and around the globe.
As a lot of our projects are in the Asia Pacific region and Europe, we are able to assist clients with a wide range of compliance strategies to meet US FDA, PIC/S and SAHPRA (formerly MCC) GMPs, as well as GACP-GMP for Medicinal Cannabis.
If you need it, we can design all 12 stages of your Medicinal Cannabis facility, read here for more information, an exciting and ever increasing service area for us.
We offer services in:
Our GMP consultants can ensure your Quality System meets the requirements of PIC/S and SAHPRA and of ICH Q10 / ISO 9001 for pharmaceutical manufacture. We have a wealth of PQS templates and documents that we can use to quickly create and customise policies, procedures, work instructions and forms for your individual business needs.
If you are about to be audited by the South African SAHPRA, or have already been audited and need help with a compliance strategy, we can help with both GMP GAP audits / assessments as well as GMP remediation plans.
Architectural and engineering consulting services
We design manufacturing facilities by focussing on the process and work flows first, then wrapping the clean room or building around the process, thus avoiding the common “shoe-horning processes into a facility” approach. While we specialise in GMP-regulated manufacturing sites, we also have an extensive record in designing laboratories, pharmacies, food and cosmetic plants.
GMP Engineering consulting
Our GMP consultants and pharmaceutical engineers are experts in GMP facility and clean room design and classification.If you are planning to build a GMP facility, our engineering consulting services can help you design compliant work areas and implement efficient workflows within the facility, avoiding any costly mistakes further down the line.
Whatever your finished product, we can help you design a validation protocol and supply validation engineers to help you identify Critical Process Parameters and Critical Quality Attributes so you can ensure that your production processes and products have been manufactured in compliance with South African SAHPRA, FDA CFR, EU PIC/S, or medical device validation regulations.
Our validation engineers can perform pharmaceutical equipment validation to international GMP regulatory standards depending on the type of equipment and its complexity.
If you need cleaning validation for pharmaceutical and medical device manufacturing facilities, our validation engineers can also perform a range of tasks to support this, ranging from preparing the high level validation plan through to actually doing the cleaning validation itself and writing the report.
Computer Systems validation
With a big regulatory focus on data integrity, another common request from our customers is for Computer systems validation to the FDA CFR 21 Part 11 and PIC/S Annex 11 regulations. We apply the ISPE’s GAMP approach to our computer systems validation
PharmOut has the specialized equipment and expertise required to undertake temperature mapping of warehouses, refrigerators and cold rooms. This is to ensure compliance with Good Warehousing Practices for time and temperature-sensitive pharmaceuticals and other products that require cold chain management.
Training for the pharmaceutical, medical device & veterinary industries
We offer flexible packages for GMP training that range from seminars and class room training, to personalised site visits and online GMP training modules that are accessible from around the world.
GMP project resources
If you have a project that needs experienced GMP professionals or several contractors, PharmOut South Africa can supply: