Asking the right questions when regulations are revised in sterile manufacturing

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Pharmaceutical Insights +

In this article, John Johnson, vice president, Pharma Biotech, NSF International, looks at the revision to Annex 1 and the important questions steriles manufacturers and pharma suppliers should be asking themselves.

Regardless of the dosage form you supply, whenever the EudraLex Volume IV GMP regulations are revised, it is important to take in the wider picture. With the introduction of a significant revision to Annex 1: Manufacture of Sterile Medicinal Products, licence holders and pharma suppliers should ask themselves:

  • Why is the regulation being changed?
  • How will it affect my operation or company as a whole?
  • Does the revision signal a change in perspective within EMA?
  • Does the revision imply how changes will be monitored and enforced?
  • What do I need to do to keep in step with these changes?

Failing to answer these questions, specific to your organisation, is like driving in the dark at breakneck speed without your headlamps on.

Whilst Annex 1 is focused on sterile production, the clarifications and changes will have a definite knock-on impact on how the regulators regulate and how the industry designs, operates and checks the effectiveness of the whole pharmaceutical quality system (PQS).

It is therefore important to examine the reasons for the revision to Annex 1 and ask yourself some key questions:

So, whether or not you are a steriles manufacturer, take time to formulate an action plan. Your EU regulator is telling you:

  • Better regulation is needed as many sectors are struggling to comply with the basic GMP requirements.
  • Product shortages, recalls and regulatory censure are troubling and demonstrate that changes across the industry in the last 10–15 years are not visibly improving the quality or safety of products manufactured or supplied in and to global markets.
  • Recurring GMP deviations and deficiencies demonstrate a lack of effective root cause analysis, a lack of rigor in identifying the right CAPA and an acceptance of variation that can significantly impact product quality.
  • Though a quality system (underpinned by a robust staff education program) is a mandatory requirement, it will not deliver the required level of quality assurance without the engagement of staff at all levels.