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“Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” published by EMA will come into force on 1 October 2019 (Part II)

  • 30 September 2019
  • active substance, API, aseptic processing, ATMP, cell based medicinal products, container, decision tree, documentation, dossier, EMA, excipients, filtration, finished dosage form, finished product, GMP, medicinal product, part, Ph. Eur., post-aseptic processing terminal heat treatment, primary, quality, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,

ASE Pharma Solutions

On 8 March 2019, the European Medicines Agency (EMA) published final version of Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. This guideline will come into force on 1 October 2019.


It provides guidance on the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur.) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative.



Guidance is also provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers in a new marketing authorisation application or a variation application for a medicinal product.

We have already informed on our website about a draft of the guideline published by the European Medicines Agency (EMA) for public consultation more than three years ago.

It is important to note that the final guidelines refer also to advanced therapy medicinal products (ATMPs) for human use as well as to veterinary cell based novel therapies.

stem cells research

The majority of ATMPs cannot be terminally sterilised. In such cases, the manufacturing process should be conducted aseptically.

For ATMPs, the microbiological quality of all components, process equipment and the aseptic techniques of the manufacturing processes are of utmost importance when the finished product cannot be sterilised. For those medicinal products that cannot be sterilised, such as cell based medicinal products, a detailed risk assessment with regards to microbial contamination should be provided.

Comparing to the draft guideline, the final version of document describes in more detail how to present documentation regarding sterilisation and aseptic processing in the appropriate sections of the quality dossier.

For example, the filter data required to be provided in the quality dossier for all filters used in the manufacture of the finished product that come in contact with the finished product, or with any component (substance or intermediate product) incorporated in the finished product are presented in the form of table.

Additionally, more information is given regarding Good manufacturing practice (GMP) for sterile active substances, sterile excipients and sterile containers comparing to the draft guideline.

Source: EMA

Related entries:

(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline

GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)

GMP for ATMPs (Advanced Therapy Medicinal Products) (Part I)

Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?