Quality in Contract Biomanufacturing

PharmaSynth services are bound by our team’s commitment to offering the best solution for the client.

Our team finds innovative ways of solving problems. We do this by utilizing our extensive experience

in development of cGMP manufacturing process and subsequent production.

PharmaSynth takes pride in providing a quality manufacturing service to an international standard.

PharmaSynth has a total quality assurance system developed and inspected in accordance with local

and international requirements.

The PharmaSynth facility follows the international GMP guidelines as setout in the (PIC/S) “Guide to

Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). Australia is also a founding

member state of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resulting in Australian

Therapeutics Goods Administration (TGA) guidelines being adopted internationally. As such our TGA

license indicated that we follow the International Conference on Harmonisation (ICH) Technical

Requirements for the Registration of Pharmaceuticals for Human Use and our TGA license is

recognized by other PIC/S member countries. Also our facility is audited routinely by the TGA and by

our clients as part of their due diligence and regulatory compliance.

Besides a license from the TGA for the manufacture of human therapeutic API’s (active

pharmaceutical ingredients) from biological and synthetic sources, the PharmaSynth facility also has

the following licences:

APVMA (Veterinary equivalent of the TGA) licence for manufacture of sterile immunobiological

products.

OGTR licence for the production of products from genetically modified organisms.

AQIS facility licence for import and use of biologic materials.

According to the TGA (Australia's Therapeutic Goods Administration) and ICH Guidelines, key quality

management principles are:

Quality should be the responsibility of all persons involved in manufacturing.

Each manufacturer should establish, document, and implement an effective system for

managing quality that involves the active participation of management and appropriate

manufacturing personnel.

The system for managing quality should encompass the organisational structure, procedures,

processes and resources, as well as activities necessary to ensure confidence that the API

will meet its intended specifications for quality and purity. All quality related activities should

be defined and documented.

There should be a quality unit(s) that is independent of production and that fulfils both quality

assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate

QA and QC units or a single individual or group, depending upon the size and structure of the

organization.

The persons authorised to release intermediates and APIs should be specified.

All quality related activities should be recorded at the time they are performed.

Any deviation from established procedures should be documented and explained. Critical

deviations should be investigated, and the investigation and its conclusions should be

documented.

No materials should be released or used before the satisfactory completion of evaluation by

the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g.

release under quarantine as described in Section 10.20 or the use of raw materials or

intermediates pending completion of evaluation).

Procedures should exist for notifying responsible management in a timely manner of

regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g.

quality related complaints, recalls, regulatory actions, etc.).

With the above guidelines and internationally recognized licenses in place, PharmaSynth offers our

clients the confidence that their product is being manufactured under the most appropriate conditions.

You can also be assured that PharmaSynth offers the most up to date practices because our scientist

not only get the job done but also show initiative such as offering suggestions for improving

processes.

PharmaSynth's quality unit is staffed with individuals that also understand processes. We therefore

are capable of identifying critical quality parameters (CPPs) and key performance indicators (KPIs),

and employ real-time monitoring and controls across the manufacturing process.

Contact Us

Email: enquiries@pharmasynth.com.au

Website: http://www.pharmasynth.com.au/