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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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Sterile medicinal products (Annex 1)

Technical interpretation of Annex 1

The TGA has endorsed a PIC/S interpretative guidance on Annex 1, which is called Technical interpretation of revised Annex 1 to PIC/S GMP Guide (PI 032-2). This document gives a technical interpretation of Annex 1.

Classification of clean-rooms

Guidance on the TGA’s expectations for the classification of cleanrooms is available in our notice on Implementation of updates to ISO 14644 Parts 1 & 2 (2015).

Highly potent or sensitising material

Generally, dedicated buildings, facilities and equipment are required for potent or highly-sensitising material manufacture. An isolator operating at negative pressure would be regarded as a 'micro-environment' and could be accepted for manufacture of a potent or highly-sensitising material provided that factors such as cleaning, sanitation (noting that if the isolator is opened during cleaning this could present specific concerns), preventative maintenance, environmental monitoring (residues), spillage, etc. are adequately addressed with respect to cross contamination. However, the manufacture of 'other drugs' in the same isolator would not be permitted.

How to access a pdf document

Further guidance may be found in the EMA’s Questions and Answers (pdf,89kb) document for risk based prevention of cross contamination.

Cleanroom clothing

Cleanroom clothing is not a therapeutic good and manufacturers of such clothing are not subject to inspection and licensing under the Therapeutic Goods Act 1989. However, licensed manufacturers of sterile medicinal products should qualify their vendors of critical goods used in the cleanrooms, such as cleanroom apparel and these relationships should be defined and managed in accordance with Chapter 7 principles.

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