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Medicinal gases guidance

Version 2.0, January 2019

15 January 2019

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Documentation (Chapter 4)

Retention of batch documents

Keep batch documentation for products:

  • with an expiry date, for whichever is the longer period, of:
    • one year after expiry of the batch to which it relates

      OR

    • at least five years after release for supply of the batch by the authorised person
  • with no expiry date:
    • for at least 6 years after completion of manufacture of the goods, in accordance with section 20 of the Therapeutic Goods Regulations 1990

Production records

Specific details for the content of batch records for medicinal gases can be found in the PIC/S Guide to GMP:

  • Annex 6 clause 17 & 30

The following clauses of Chapter 4 of the PIC/S Guide to GMP apply to each batch of medicinal gas filled:

  • packaging instruction (clause 4.19)
  • batch processing record (clause 4.20)
  • batch packaging record (clause 4.21)

Clauses of Chapter 4 of the PIC/S Guide to GMP that do not apply to medicinal gas manufacture include:

  • manufacturing formula (clause 4.17)
  • processing instructions (clause 4.18)

Control of cylinder product labels

For starting materials and packaging materials (clauses 4.21-4.27), including cylinder product labels, provide written procedures and records, for:

  • receipt
  • storage
  • sampling
  • testing
  • release/rejection

For cylinder product-labels, provide written procedures for how to:

  • quarantine
  • inspect
  • release
  • issue to production
  • control

It is not mandatory to reconcile cylinder product label usage for each batch at the filling stations.

Establish processes to:

  • control changes in product labels
  • ensure all obsolete labels are removed from the site and destroyed where a ‘hard label’ change is required

Maintaining policies, procedures and records

Provide appropriate documentation to demonstrate compliance with each element of clause 4.29.

Where reference is made to environmental monitoring, this is normally limited to monitoring of specific processing or storage conditions, for example, temperature, where required by the process.

Further guidance is provided in Annex 6 clause 17 & 18.

Log-books

Use logbooks for all analytical equipment.

Where there is adequate traceability of activities, logbooks are not required, for:

  • product-specific (dedicated) equipment
  • areas utilised for production

Signature list

For individuals who complete GMP documentation, maintain a signature list that includes:

  • names
  • signatures
  • initials

The signature list is the key reference when providing traceability between manual signatures used on documents and the individuals who completed them.

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