Pharma manufacturers asked to comment on new GMP draft guidance
Comments should be sent to European Commission by 31 May
European Union (EU) pharmaceutical manufacturers have been asked to comment on a new draft set of EU good manufacturing practice (GMP) guidance on qualification and validation. The European Commission (EC) has been updating this guidance taking account of new best practice and technology, and is due to authorise these revised rules in October.
The EC is consulting on a new text for Annex 15 of the EU’s GMP system, which covers validating the quality of facilities, equipment, utilities and medicine manufacturing processes.
A key shift in the new text is a priority given to ensuring such controls cover the lifecycle of a product and process.
'Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed,' the EC said. 'Computerised systems used for the manufacture of medicinal products should be validated.'
Quality risk management should be applied throughout the lifecycle of a medicinal product
The EC stressed that written procedures must be in place to describe actions required if a planned change is suggested for starting materials, product components, process equipment, premises, product range, methods of production or testing, batch size, design space that may affect product quality or reproducibility.
Another theme that has gained in prominence is quality risk management, which the new GMP guidance insists 'should be applied throughout the lifecycle of a medicinal product'. Such systems must ensure that validation and qualification decisions are based on 'a justified and documented risk assessment of the facilities, equipment, utilities and processes'.
Risk assessments should be repeated, as required, if increased knowledge and understanding emerges from any changes made to a project, including during commercial production. And the way risk assessments support validation activity should be clearly documented, said the EC. The number of batches manufactured and samples taken during product development should be based on quality risk management principles.
Another noteworthy element highlights the use of third parties. Where they supply validation protocols, 'the manufacturer should confirm suitability and compliance with company procedures before approval,' said the new GMP draft.
Comments on the draft should be sent to ADM-GMDP@ema.europa.eu and sanco-pharmaceuticals-D6@ec.europa.eu by 31 May.
