About PharmOut
PharmOut is an international GMP consultancy to the pharmaceutical, and medical device industries and to regulatory authorities.
We consult and train on regulatory GMP compliance, product registration, validation and continuous improvement of manufacturing processes.
What we offer
PharmOut has six core offerings:
- Providing consulting and resources for the validation of processes, facilities, services and equipment; cleaning and computer systems
- Consulting on GxP compliance to PIC/S (EU) and FDA (USA) regulations
- Consulting on how to combine GMP compliance with common continuous improvement techniques (6 sigma, Lean Manufacturing, 5S etc.)
- Training people in validation, GMP compliance and continuous improvement
- Consulting on the Australian Therapeutic Goods Administration’s drug and device registration process
- Medical device and Pharmaceutical facility engineering design.
PharmOut tackles validation, registration, compliance and continuous improvement projects on a fixed price or hourly rate basis.
Our Team
Our team includes:
- GMP Consultants
- Validation Consultants
- Regulatory Affairs Consultants
- Professional Trainers
- Technical Writers and other life science specialists
- Pharmaceutical Engineers.
We can deliver highly experienced consultants or contractors at short notice.
PharmOut’s team includes international GMP experts and consultants who previously held leadership roles within regulatory bodies.
Trevor Schoerie
PharmOut’s Managing Director, Trevor Schoerie, has 20 years of manufacturing and 8 years of consulting experience in the chemical, pharmaceutical, pesticides & veterinary drugs industries.
Trevor believes strongly in sensible, practical compliance that delivers business results, not just audit success.
His area of expertise is combining GMP compliance with continuous improvement methods such as Lean Manufacturing.
Bob Tribe
Bob Tribe is an experienced, approachable, industry veteran who has been a key player in the development of the GMP standards and their application within Australia and internationally.
Bob was previously the Chief GMP Auditor for TGA, Australia (1980 – 2003) and Chairman of the Pharmaceutical Inspection Cooperation Scheme [PIC/S] (2000 – 2001).
He is a current regulatory advisor to the ISPE, special advisor to a number of regulatory authorities seeking PIC/S accreditation.
Gordon Farquharson
Gordon Farquharson is widely recognised as a world leader and expert in sterile products manufacture, clean room design and maintenance and utilities for the same.
Gordon is the Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards.
He is also an advisor to the EMeA concerning the revision to Annex 1 of the EU GMP in February 2008 and a member of the WHO expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).
Our industries
PharmOut consults to those industries subject to European (EMA), U.S. (FDA) and Australian (TGA), drug and medical device regulations:
- Pharmaceutical manufacturers
- Medical device manufacturers
- Manufacturers of veterinary and pesticide products.
It’s our job to not only know the relevant regulatory codes inside out, but to know how to comply with them cost effectively. Using a risk based approach we focus on the process areas that will have the most impact on product quality – rather than simply treating the whole process equally
Typical projects we take on
- GLP/GMP Quality Management Systems, compliant with FDA, EMA and TGA regulations (PIC/S).
- Audit readiness assessments and audit remediation to FDA CFR 210/211, CFR 820
- Implementing Quality Management Systems for Pharmaceutical or ISO 13485 for Medical Device standards
- International Regulatory GMP assistance to obtain approval from the FDA, EMA, MHRA or TGA
- Part 11 and Annex 11 compliance to FDA and TGA requirements
- Preparation of dossiers for drug and device registration with the TGA.
Some examples of our work
PharmOut works with some of the most successful pharmaceutical and medical device companies in the Asia Pacific region.
Examples of projects we have completed include:
-
In the Philippines, we trained the auditing team of the country’s regulatory body in preparation for their application to join PIC/S.
-
In Australia, we validated a flu vaccine manufacturing process for a global biopharmaceutical company
-
In Singapore, we validated a clinical services computer system for a multinational specialist logistics company, supplying the pharmaceutical industry.
Contact us
PharmOut Australia
Unit 20
40 Montclair Ave
Glen Waverley, 3150, VIC
Australia
ph: +61 3 95 61 4803
fax: +61 3 86 100 169
email:
info@pharmout.com.au
PharmOut Singapore
3 Raffles Place
#07-01 Bharat Building
Singapore 048617
ph: +65 6329 6545
fax: +65 6491 6591
email:
info@pharmout.sg
PharmOut Hong Kong
Level 19
Two International Finance Centre
8 Finance Street
Central
Hong Kong
China
ph: + 852 2251 1770
Fax: +852 3010 4785
email:
info@pharmout.hk
PharmOut Beijing
Representative Office
Level 19, Tower E2
Oriental Plaza,
1 East Chang An Avenue,
Dong Cheng District
Beijing 100738
P.R.C., China
ph: +8610 8520 0309
email:
info@pharmout.cn