Good Manufacturing Practice Policy

Purpose. Commits the Western Sydney site to manufacturing medicines under the Australian code of good manufacturing practice and defines the quality system that gives effect to it.

1.Scope

This policy applies to every activity at the Western Sydney pharmaceutical site, including dispensing, manufacturing, packaging, testing, storage, release and the supporting utilities and systems. It gives effect to the licence held under the Therapeutic Goods Act 1989 and to the Australian code of good manufacturing practice for medicinal products.

2.Quality system

The site will operate a documented pharmaceutical quality system covering personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls and self inspection. Every batch will be manufactured to an approved batch manufacturing record and released by the authorised person only after the record has been reviewed.

3.Documentation

Records must be made at the time of the activity, in indelible ink or in the validated electronic system, by the person who did the work, and verified by a second person where the record requires it. Corrections must be single line, initialled, dated and explained. Blank fields are not permitted.

• Record at the time of the activity
• Attributable, legible, contemporaneous, original and accurate
• Second person verification where required
• No blank fields, no overwriting

4.Deviations and change control

Any departure from an approved procedure, record or specification must be recorded as a deviation on the day it is identified and investigated to root cause. No change to a process, material, equipment, system or document will be made without an approved change control.

5.Personnel

Every person entering a controlled room must be trained in gowning and hygiene and must have a current health declaration. Training will be recorded before the person performs the task unsupervised. Visitors will be escorted and will gown to the same standard.

6.Self inspection

The site will conduct self inspections against the code to a published schedule, record findings and track corrective actions to closure. Regulatory inspections will be supported with full and prompt access to records.