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EMA published a Draft guideline on manufacture of the finished dosage form (Part I)

  • 26 August 2015
  • bulk, control strategy, CTD, design space, finished product, GDP, intermediate, manufacture, process description, RTRT, storage, transport,
On 9 July 2015, EMA released for 6 months public consultation the Draft guideline on manufacture of the finished dosage form. It should be mentioned here, that the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (current guideline) was originally presented in the document entitled Concept
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ICH published a Final Concept Paper for a new ICH Q12 Guideline

  • 25 February 2015
  • change management, chemistry, CMC, continual improvement, control, ICH Q12, knowledge management, lifecycle management, management of post-approval CMC changes, manufacturing, prospective change management,
Recently, ICH published a Final Concept Paper for a new ICH Q12 Guideline entitled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. There is currently a lack of a harmonised approach on technical and regulatory considerations for product lifecycle management. While the concepts in ICH Q8, Q9, Q10 and Q11 provide opportunities for a
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Active substance starting material(s) – importance of selection

  • 4 December 2014
  • active substance, API, cell banks, cell substrate, GMP, ICH Q11, Master Cell Bank, MCB, redefinition, starting material, WCB, Working Cell Bank,
According to the Part II: Basic Requirements for Active Substances used as Starting Materials of the EU GMP Guide, the manufacturer should designate and document the rationale for the point at which production of the active substance begins. For synthetic processes, production of the active substance begins at the point at which “Active Substance Starting
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Audits of the manufacturers and distributors of active substances – Legal basis

  • 29 September 2014
According to an Article 46(f) of Directive 2001/83/EC as amended for medicinal products for human use, the holder of a manufacturing authorization shall at least be obliged: “to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with
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