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Manufacturing Process. Rutendo Kuwana Technical Officer, WHO, Geneva. Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

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Manufacturing Process

Rutendo Kuwana

Technical Officer, WHO, Geneva

Training workshop: Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data submitted to regulatory authorities, February 23-27, 2009, Kampala, Uganda.

finished pharmaceutical product manufacturing
Finished Pharmaceutical Product Manufacturing
  • Manufacturing and marketing authorization
  • Pharmaceutical development
  • Formulation
  • Sites of manufacture
  • Manufacturing process
  • Manufacturing process controls of Critical steps and intermediates
  • Process validation and Evaluation
manufacturing site s
Manufacturing site(s)
  • Name and street address of each facility where any aspect of manufacture occurs including production, sterilisation, packaging and quality control
    • Including any alternative manufacturers
  • Certificate issued by the Competent DRA according to WHO Certification scheme for each site where a major step of manufacturing is performed
  • Valid GMP certificate (may not insist if inspected by WHO)
manufacturing process
Manufacturing Process
  • Flow chart with indication of each step showing where materials enter the process. Indication of critical steps and in-process controls
  • Description of manufacturing/packaging including
    • Scale
    • Equipment by type (e.g. tumble blender) & working capacity
    • Process parameters for steps, (e.g. time, temperature, pH)
    • Environmental conditions, e.g. relative humidity for hygroscopic FPPs., area class for sterile FPPs
manufacturing process cont
Manufacturing process (cont.)
  • Proposal for reprocessing – justified with data.
  • Copy of master formula.
  • Batch manufacturing record – real batch.
  • Sterile products – sterilisation steps and/or aseptic procedures.
  • Description of in-process tests including plan of sampling and acceptance limits).
  • Data for 3 full scale batches to support achievement of predetermined specifications.
manufacturing process controls of critical steps and intermediates
Manufacturing Process Controls of Critical steps and Intermediates
  • Identification of critical steps with test methods and justified acceptance criteria
  • Information on quality of isolated intermediates, test methods and justified acceptance criteria to control them
process validation and evaluation
Process Validation and Evaluation

WHO validation definition

The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.

what should be validated
What should be validated ?

“Any aspect of operation, including significant changes to the premises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated”

purpose of process validation
Purpose of Process Validation

Process validation is intended to establish that the proposed manufacturing process is a suitable one and yields consistently a product of the desired quality.i.e. that the process is suitable and under control

process validation and evaluation10
Process Validation and Evaluation

Validation is mandatory for processes including all critical steps

The aim is to show that critical steps are under control and lead continuously to the desirable quality

Examples of critical steps (list non exhaustive)

  • mixing,
  • coating,
  • granulation,
  • emulsification,
  • non-standard sterilisation
process validation and evaluation details required on first 3 production batches
Process Validation and Evaluation Details required on first 3 production batches
  • Batches

batch number

batch size

place and date of manufacture

batch number of API(s)


batch purpose (validation, stability, clinical trial …)

  • Process


process parameters

validation protocol.

  • Results

critical steps

in process control

finished product specification

other requirements
Other requirements
  • Concurrent validation carried out during normal production on the first 3 consecutive production batches


  • For well-established processesprocess data, in-process controls and quality controls on a total of 10- 25 batches to present a statistically significant picture

If validation data (on production scale batches) are not available submit

  • validation protocol,
  • commitment that validation report will be submitted later for evaluation,
  • commitment that data will be available in case of inspection,
  • commitment that WHO will be informed of any significant deviation.
validation protocol
Validation Protocol
  • Objective, Scope and Rationale
  • Brief description of the process with summary of critical steps and parameters to be followed during validation, process flow chart
  • specifications and analytical methods of the FPP at release,
  • details of analytical procedures and limits,
  • List of equipment to be used
  • sampling plan and acceptance criteria
  • Defined CPPs to be monitored and CQAs to be tested
  • proposed timeframe

Validation report when submitted should include results for each batch, certificates of analysis, batch production records, report on unusual findings, modifications, observations and conclusions

validation report outline each batch
Validation Report Outline – Each Batch
  • Objective
  • Scope
  • Validation Batch Information
  • Deviation report
  • Critical Quality Attributes (CQAs) Test Data
  • Statistical Evaluation of CQAs
  • Conclusion

NB: One batch, One Report

validation report outline final
Validation Report Outline – Final
  • Objective
  • Scope
  • Validation Batch Information Summary
  • Summary on CQAs and Test Data evaluated
  • Overall Conclusion
  • Recommendation

NB:Three Batches, One Report