It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

In recent months, the Australian government’s Therapeutic Goods Administration (TGA) announced it will adopt an updated version (1) of the Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) Good Manufacturing Practice (GMP) Guide for Medicinal Products. Dubbed PIC/S Guide to GMP PE009-13, the updated document provides manufacturing principles for medicines and active pharmaceutical ingredients to conform to recommended guidelines. The guide lays out a set of principles and procedures to help ensure that therapeutic goods are of high quality, and that manufacturers are licensed.

The TGA administers everything from everyday therapeutic goods, such as vitamin tablets and sunscreens, to those used to treat serious conditions, such as prescription medications, vaccines, blood products, and surgical implants. 

More specifically, PE009-13 encompasses key changes in the form of revisions to Chapters 1, 2, 6, and 7 (Part I) of the PICS/Guide to GMP. Since the TGA adheres to internationally harmonised manufacturing standards that allow manufacturers to operate in international environments, periodic alterations to the guide are necessary. By their nature, the standards facilitate greater mutual confidence among overseas regulators and promote quality assurance best practices amongst international inspection partners. The TGA keeps its GMP policies current through PIC/S’ revisions.

In short, PE009-13 supports Australian pharmaceutical manufacturers in establishing a competitive edge in the ever-changing worldwide pharma market by ensuring that their medicinal products meet the highest standards in terms of safety and quality. By continuously holding the bar for excellence high, Australian manufacturers can go head-to-head with international competitors and bridge their products to new and emerging markets. PE009-13 took effect Jan. 1, 2018, and the TGA set up a transition period (2) from the old to the new that expires Jan. 1, 2019. The Administration has also made available a transition plan to assist manufacturers in implementing the changes.

Challenges to Transition

After reviewing PE009-13, I’ve identified three hurdles that pharmaceutical manufacturers face in implementing the new guidelines during the transition period:

• Implementing the required changes in a timely fashion to meet the Jan. 1, 2019, deadline.
• Conducting gap analysis to determine the effectiveness of a given company’s existing quality management system.
• Properly assessing the resources needed to acquire and implement the changes.

Companies should start sooner rather than later to assess what changes are relevant and begin by assigning and planning the resources required to make changes to their quality management system. If organisations don’t have the resources they need for the transition, they may be able to locate an experienced consultant to drive the project so they comply with PE009-13.

A Road Map and More

The TGA’s expectation is that by July 1, 2018, manufacturers will have:

1. Completed their assessment of the impact of the new manufacturing principles on their operations
2. Completed, or be well advanced, toward updating quality systems documentation and implementing revised practices

‘We recognise the complexity associated with these changes and have therefore provided appropriate timeframes for implementation, which reflect the complexity and significance of each change,’ the TGA states on its new GMP requirements website. ‘Where the impact is minimal to the manufacturer, we would expect that adoption would be well progressed or implemented by July 2018, unless justified.’

As part of its transition plan, the TGA has made available a plan diagram and transition plan tables for each amended chapter included in PE009-13.

To help manufacturers navigate the transition, MasterControl, a leading provider of enterprise software solutions that enable life science and other regulated companies, has produced the free Q&A document, ‘Understanding Australia’s Therapeutic Goods Administration (TGA) Updated PIC/S GMP Guide PE009-13.’ This article will be useful to manufacturers as they assess the resources needed to begin the transition, conduct gap analysis, and implement the needed changes by the Jan. 1 deadline.

And because the amended GMP requirements may require some manufacturers to implement or modify processes that provide improved or more detailed evidence of compliance, an automated quality management system may be just the solution pharmaceutical companies are looking for. A QMS that monitors all the quality processes that affect GMP compliance, including document control, training management, and CAPA management, can significantly improve a company’s ability to increase compliance and quality control while reducing deficiencies and corrective action incidents.