MCC Consultants, Validation, Engineering & Architecture and GMP services
PharmOut has a South African Head Office in Cape Town and frequently operates in Southern Africa, specialising in the GMP design, architecture, engineering and validation with offices across Asia Pacific and Europe and headquartered in Melbourne.
PharmOut has growing expertise in Medicinal Cannabis, with international experts based in Northern America and around the globe. We can design all 12 stages of a medicinal cannabis facility, read here for more information.
Most our projects are the Asia Pacific region and Europe delivering compliance to US FDA, PIC/S and MCC GMPs as well as GACP to German requirements for Medicinal Cannabis.
We offer services in:
Our GMP consultants can ensure your Quality System meets the requirements of PIC/S and MCC and of ICH Q10 / ISO 9001 for pharmaceutical manufacture. We have a wealth of QMS templates and documents that we can use to quickly create policies, procedures, work instructions and forms. More >
Architectural and engineering consulting services
We design manufacturing facilities, clean rooms from the optimising the process and work flows first, then wrapping the clean room or building around the process, we specialise in GMP-regulated manufacturing sites, but have an extensive record in laboratories, pharmacies, food and cosmetic plants.
GMP Engineering consulting
If you are planning to build a GMP facility, our engineering consulting services will ensure regulatory compliance and efficient workflows within the facility.
Our GMP consultants and pharmaceutical engineers are experts in GMP facility and clean room design and classification. You can avoid costly mistakes by making sure the design of your new clean room or GMP facility adheres to the correct standards.
We can design a validation protocol or supply validation engineers to ensure compliance with South African MCC or FDA pharmaceutical or medical device process validation regulations.
Our validation engineers can perform pharmaceutical equipment validation to international regulatory standards and in accordance with current GMPs.
If you need cleaning validation for pharmaceutical and medical device manufacturing facilities, our validation engineers can perform a range of tasks, ranging from preparing the high level validation plan through to actually doing the cleaning validation.
Computer Systems validation
Computer systems validation to FDA Part 11 and PIC/S Annex 11 regulations is another common request from our customers. We apply the ISPE’s GAMP approach to our computer systems validation.
PharmOut has the specialized equipment and expertise 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 subject to cold chain management.
Training for the pharmaceutical, medical device & veterinary industries
We offer class room training or on line GMP training around the world.
GMP project resources
If you have a project that needs experienced GMP professionals or several contractors, PharmOut South Africa can supply:
- Pharmaceutical Engineers,
- GMP Consultants,
- Validation Consultants,
- Regulatory Affairs Consultants
- Technical Document Writer
- GMP Engineers
Medicinal Cannabis Consultants
PharmOut are the leading Medicinal Cannabis Consultants within the Australia New Zealand region, we are the leading Medicinal Cannabis Consultants offering turn key designs for both the head and grow houses. PharmOut has a the ability to offer a full range of services from compliance licensing, cultivation, production, extraction to final dosage forms from a US office and experienced master growers. We like to think of it as hardware (facility design and engineering) and software (paper systems), after all GMP is often said to mean “Get More Paper”.