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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.
Reģistrācijas numurs (WIID)
82817
Darbības sfēra
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.
