EMEA reviewing GMP guidelines provisions on starting materials
European Directive 2004/27/EC requires that active ingredients used in medicinal products must be produced in accordance the principles of Good Manufacturing Practice (GMP) as set out in Part II of the European GMP Guidelines.
European Directive 2004/27/EC requires that active ingredients used in medicinal products must be produced in accordance the principles of Good Manufacturing Practice (GMP) as set out in Part II of the European GMP Guidelines.
However, Chapter 5 of those Guidelines, which covers production and includes a section on starting materials, does not reflect the new requirement and the expectations for the qualification of active substances manufacturers need updating, asserts EMEA. Likewise, the new GMP requirement for certain excipients under 2004/27/EC is not reflected in the Chapter 5 section on starting materials.
To open a debate on rectifying these deficiencies in the GMP Guidelines, EMEA has issued a Concept Paper outlining its plans to amend Chapter 5 accordingly and taking into account the sometimes complex supply chain for starting materials.
Perhaps of more interest in the Concept Paper is the EMEA's stated concern at the lack of harmonisation by member states of the requirements for the testing of starting materials to confirm their suitability for use. It notes that there are two basic approaches current in the EU with some member states requiring testing of starting materials by the manufacturing authorisation holder himself and others allowing the use of certificates of analysis by the supplier.
EMEA states that a harmonised approach is desirable "taking into account the principles of risk management (and)..striking a balance between assurance of quality, and therefore the safety of patients and product efficacy, and the efficient use of resources". EMEA recommends a new section on this issue be inserted in Chapter 5.
The deadline for comment on the Concept Paper is 31 August and a draft revised Chapter 5 is anticipated by the end of September with a comment period until March 2008. The adoption of a final text is scheduled for October 2008.
The response to the Concept Paper and the ensuing draft will be awaited with interest and we will follow its progress in this column.