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Compounded medicines and good manufacturing practice (GMP)

Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products

29 May 2017

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Interpretation - documentation - chapter 4

Topic PIC/S clause Interpretation
Record retention periods 4.9

Records relating to the preparation of the dosage should be kept for at least 1 year after expiry date.

Records relating to personnel training, equipment, validation, risk assessments etc., should be kept for the period they are in use (lifetime) or 1 year after the expiry of medicines to which these records relate, (whichever is the longer period)

Starting material specifications 4.11

Each starting material should be supported by a specification identifying the key requirements, as per clause 4.11.

However, for starting materials that are registered therapeutic goods a specification identifying the key requirements, including (as a minimum) the following should be available:

  • Item name
  • approved supplier and manufacturer
  • ARTG number

Where registered goods are used, inclusion of a photo is encouraged as a means to assist the identification of the item being received and approved for use.

Where starting materials consist of APIs and excipients, e.g. clinical trial manufacture, full compliance with GMP requirements for management of raw materials and suppliers would be expected (Chapter 5 and Annexes 8 & 13).

Manufacturers should also have a complete knowledge of the supply chain for each starting material.

Finished product specifications 4.13

Compounded medicines are not exempt from meeting the quality standards set out in the Therapeutic Goods Act 1989.

The finished product specifications for compounded medicines should reflect the relevant monographs from the BP/EP or USP, including relevant standards on microbial quality.

For BP/EP: Compliance with the general monographs applicable to the dosage form is expected, e.g. Tablets, Parenteral Preparations, Unlicensed Medicines. In addition, compliance with any specific monographs for the formulated preparation is expected.

For USP: Compliance with the relevant general monographs applicable to the dosage form, e.g. Injections, is expected. In addition, compliance with any specific monographs for the formulated preparation is expected.

Individual monographs are intended to apply throughout the period for which the formulation is expected to be satisfactory for use.

The batch record may fulfil the requirement of a finished product specification in some circumstances.

Where product release requires the results from prospective testing, this should be clearly defined.

Batch and packaging instructions and records 4.14 - 4.18

The requirements of the PIC/S Guide to GMP still apply, although it is common for these to be included in one concise document.

All items which are part of the final pack should be included in the Bill of Materials (BOM) with their batch number. Where a separate BOM is not used, these items should be listed on the batch record.

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