DIN Standards Committee Health Technologies
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of Manufacturing Process & Controls Information of products and substances for pharmaceutical industry
Abstract
The scope of this new standard is to harmonize Chemistry, Manufacturing & Controls information of pharmaceutical products and substances, by structuring the Core Quality, aligned with ICH M4Q(R2). In details: Manufacturing Description of the Manufacturing Process: • Narrative summary and flow diagram/process schematic of the drug substance commercial manufacturing process. • Sequence of unit operations and scale of production, including substance intermediate(s), if applicable. • Points of sampling for in-process controls, intermediate tests, or final drug substance controls in the diagram. • Chemical structures in the diagram/schematic, as appropriate. • Information on: o Definition of batch size/scale. o Starting/source materials. o Quantities of raw materials (for chemical entities). o Major equipment (for biologics). o Aseptic processing procedures. o Intermediates and their holding times. • Process parameters impacting drug substance quality and manufacturing consistency (process parameter types & criticality to differentiate CPPs from non-CPPs, CQA/CMA) • Method of sterilization and appropriate acceptance criteria for sterile drug substances. • Unit operations executed in batch mode or continuous manufacturing process. • Proposed design space (ICH Q11, Q13). • Reprocessing steps included in the process flow diagram (ICH Q7). Process Controls: • CPPs and IPCs essential for ensuring consistent production of drug substance of required quality (Identification of CQA/CMA & criticality) • Associated test methods and control ranges/acceptance criteria, organized per unit operation. Control Specification(s) (valid for all materials i.e. for the Drug Substance, Raw Materials, Starting Materials, Excipients, even packaging material etc.): • Tests, references to analytical procedures, and acceptance criteria for both release and shelf life/retest period, if applicable • Test purpose / type (e.g. Identity, purity, microbiological etc.) • Compliance with applicable standards/pharmacopeia. • Description of the Real Time Release Testing (RTRT) approach, if applicable (ICH Q6A, Q6B, Q6C, Q6D, Q14, M7). Analytical Procedures • Name of the procedure, purpose of the test • Per method operational step: Parameters needing control to ensure the performance of the procedure, type of equipment used Possible addition of supportive data (low hanging fruits): • Analytical results Storage Container Closure System Stability, storage conditions, and retest period/shelf life Shipping Conditions Possible addition of supportive data (low hanging fruits): • Stability results This standard aims to propose normative elements for the description of Manufacturing Process & Control Information of products and substances for pharmaceutical industry normative data elements and structure. Any informative example and contextual information are not in scope and would be proposed in a separate Technical Specification, if the expert community expresses the need.
Begin
2025-10-03
WI
00251435
Planned document number
prEN ISO 26060
