In April 2013, the Australian Therapeutic Goods Administration released the first version of its much anticipated Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. These requirements commenced on 31st May 2013 with a 12-month grace period requiring full compliance by 31st May 2014.
Within the ‘blood and tissues’ code of GMP there are several components which undoubtedly, will be keenly debated.
Here are my top five items for your consideration:
1. Design and development not pharmaceutical development?
Within the Quality Management section, the term ‘designed and developed’ (common with PIC/S GMP) is used in the context of Quality Assurance. The concept of design and development will be familiar to those in the medical device industries (refer to section 7.3 of ISO13485, entitled ‘Design and development’).
The reference to medical device terminology and process is striking.
Among the major influences on international GMP compliance are the ICH Quality Guidelines, in particular the ICH tripartite documents. ICH Q8 (R2), entitled ‘Pharmaceutical development’, has many principles that are relevant to blood and tissues.
A closer alignment with recognised GMP influences at an international level would have allowed greater opportunity for therapeutic product regulators and blood and tissue regulators to share compliance concepts.
2. Authorised, responsible, competent people
‘Authorised person’ is another term that may surprise some in the life sciences industries. The WHO refers to Authorised persons and the EU refers to qualified persons.
Authorised persons will have significant responsibilities within compliance functions and the rationale for the identification and qualification of authorised persons is certain to attract a lot of attention.
3. Quality risk management
The word ‘risk’ is mentioned 18 times within the blood and tissues GMP code, however no references or definitions regarding this critical concept are provided. The opportunity for alignment with ICH quality guidelines is apparent.
ICH Q9, Risk Management, certainly could apply to blood and tissues regulation.
Clause 9.15 relevant to Product Release and products not meeting specifications “only when a risk based approach and/or regulatory requirements have been met can such products to (sic) be released.”
4. Validation protocols
Within the Equipment section, a direct reference to “protocols, which address installation (IQ) and operational (OQ) qualification…” is made.
Many regulators and influencers (including the US FDA Process Validation Guidance and EMA draft Process Validation guidance) to life sciences compliance have deliberately avoided direct reference to IQ and OQ protocols, instead focussing their attention on the overall concept of validation and the robustness of process to repeatedly produce safe and effective products.
If an item of equipment were appropriately and adequately verified and validated, but the supporting documents were not titled consistently with IQ, OQ or PQ references, will this have any impact on compliance?
5. Computers and computerised systems
Finally, the section on Computers – with the publication of EU Annex 11 and the TGA’s recently announced consultation for the potential adoption of PIC/S PE009-10 to Australian legislation, has another opportunity for harmonisation been lost?
Annex 11 within the PIC/S PE 009-10 GMP guide provides guidance for managing compliant computerised systems and provides emphasis on system control and data security considerations.
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