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PE009-13, the PIC/S guide to GMP for medicinal products

TGA interpretation and expectations for demonstrating compliance

2 January 2018

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Production (Chapter 5)

Listed medicine production

Process validation for listed medicine manufacturers

A separate guidance document is available for process validation for listed complementary medicines.

The technical GMP guidance for listed complementary medicines are baseline documents, elements of which can also be applied to other listed medicines if justified.

Although the principles in this guidance are still applicable, it will be revised where necessary, in consultation with industry, to clarify requirements in the PE009-13 version of the PIC/S Guide to GMP.

Supplier qualification for non-sterile and complementary medicines

A separate guidance document is available for Supplier qualification for non-sterile and complementary medicine manufacturers.

Although the principles in this guidance are still applicable, it will be revised where necessary, in consultation with industry, to clarify requirements in the PE009-13 version of the PIC/S Guide to GMP.

Labelling and packaging

Label counting and verification

Roll labels must be counted either on receipt or at issue. Supplier counts are not acceptable unless the supplier is specifically qualified and supplier certifies the exact count for each roll. Supplier sequential numbering on the backing web of labels is an acceptable alternative.

Cut labels must be counted and effectively verified by the manufacturer because of risks of mix-ups.

Unique batch numbering

The system that a manufacturer adopts for batch numbering may include numerals, letters or symbols (or any combination of these) and must effectively serve to identify uniquely a batch of product, and from which it is possible to trace that batch through all stages of manufacture and distribution. The manufacturer should be able to demonstrate that the system for batch numbering meets these requirements and is effective.

Unpacked bulk products, should have a batch number that is unique to both product and batch, to minimise the potential for mix-ups during manufacturing. For finished products which are easily distinguished, a batch numbering system that only designates batches from that product may be acceptable.

The topic of batch numbering is dealt with in:

TSE status of materials

The TGA has published guidance relating to the management of materials susceptible to TSEs (transmissible spongiform encephalopathies) used in the manufacture of therapeutic goods. Manufacturers should undertake an assessment of materials used in the production of medicinal products and ensure that current evidence to demonstrate the TSE status of materials is held and available for inspection.

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