EMA has issued a draft guideline to clarify the type and level of information that should be included in the CTD Module 3 of the marking authorization application (MAA) dossier with respect to the manufacturing process description. The document was drafted in light of increased outsourcing and the growing complexity of supply chains.
The draft is intended to replace the note for guidance on the manufacture of the finished dosage form, which was written at a time when pharmaceutical supply chains were simpler. With supply chains now including multiple companies from across the globe, EMA has updated its stance on what details companies should include in MAAs. EMA has also included the content and principles of ICH Q8 into the draft guidelines. Definitions from ICH Q8, such as control strategy, CPP, CQA, design space, and RTRT are captured within the guideline.
Note that the headings in the guideline follow the structure of the CTD format Module 3, Section 3.2.P.3 Manufacture.
The guideline applies to the manufacture of finished dosage form of chemical medicinal products for human use intended for marketing authorization. It also applies to variations for authorized products in cases where changes to the manufacturing process affecting the MA are proposed. The principles described are in general also applicable to biological medicinal products but not to advanced therapy medicinal products. Application of this guideline to the manufacture of investigational medicinal products is not intended, but the principles of this guideline may be applied.
