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Revision of the EU GMP Guide – Chapters 3 and 5

  • 4 October 2014

ASE Pharma Solutions

On 13 August 2014, the European Commission published revised versions of Chapter 3: Premises and Equipment and Chapter 5: Production of the EU GMP Guide. The new chapters will become effective on 1 March 2015.

Chapter 3: Premises and Equipment

The revision concerns section 3.6 as part of the improved guidance on prevention of cross-contamination involving also Chapter 5. Current version of section 3.6 states that the measures to prevent cross-contamination should be commensurate with the risks, and the principles of Quality Risk Management should be used to assess and control the risks. Revised section 3.6 indicates also the exceptions where dedicated facilities are required – which are:

  1. the risk cannot be adequately controlled by operational and/ or technical measures,
  2. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) or
  3. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.

It is worth to add here that Chapters 3 and 5 should be read in conjunction with the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, which is still in draft stage.

Chapter 5: Production

Revised sections 5.17 to 5.21 include an addition of a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment. Section 5.21 states that: “The outcome of the Quality Risk Management process should be the basis for determining the extent of technical and organisational measures required to control risks for cross-contamination. (…)”.

Changes were also introduced in sections 5.27 to 5.30, including adding a new section, on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability from active substance starting materials to the finished medicinal product.

Sections 5.35 and 5.36 are inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials.

Section 5.71 introduces guidance on notification of restrictions in supply. If the product ceases to be placed on the market, either temporarily or permanently, based on legal obligations, Marketing Authorisation Holder shall notify the relevant competent Authorities.