Compliance by Design and Compliance Master Plan - Pharmaceutical Technology

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PharmTech Europe

Compliance by Design and Compliance Master Plan
The authors review a compliance-by-design approach to quality systems.


Pharmaceutical Technology
Volume 35, Issue 3, pp. 90-96

Analysis of each individual system. After all individual systems (e.g., stability system, training system) are identified, each is analyzed and evaluated. The following actions would be performed on the individual system:

  • Identify the complete business process for the system: These may be relatively complex with multiple individual functions with global components, or they may be less complex, such as the training system with a centralized function and direct involvement with all functional areas in a facility.
  • Identify system subsections: After the business process is identified, logical subsections can be determined that represent distinct groups of activities within the quality system. These may be individual departments within the organization. Identify objectives, critical compliance attributes, CPPs, variation, controls, and maintenance for all subsections.

Gap analysis for each individual system and subsystem. Identify any gaps in subsections and initiate corrective action. Procedures should be available for all significant activities in each subsystem. If needed, a commitment to develop new procedures should be made. Management, staff, and the quality assurance (QA) department should conduct this analysis with cross-functional input. Staff participation and cross-functional input is critical for the success of the analysis. Process experience, vendor audits, product data, deviations, corrective action and preventive action (CAPA), and other sources of information should be used to identify gaps or problem areas.

Risk analysis. Subsections are evaluated with regard to risk. If procedures are not appropriate for high-risk activities, they should be appropriately enhanced. Conversely, attention to lower-risk areas may be appropriately reduced. Risk to the patient, the process, and the organization (i.e., business risk) should be considered.

Continuous improvements. Continuous-improvement projects based on gap analysis, risk analysis, and system performance should be identified.

Performance measurement. Performance measurement parameters should be identified, monitored, and trended as appropriate. Corrective actions should be initiated as appropriate. Improvement projects should also be initiated as appropriate.

Documentation . All of these implementation strategies should be documented in the CMP.

A CbD example: materials system business process

This section provides a high-level description of the steps involved in the business process for the materials quality system in a pharmaceutical manufacturing facility.

  • Step 1: Identify approved vendors to source incoming materials (the vendor QA department audits potential suppliers and approves vendors)
  • Step 2: Incoming materials are received at manufacturing site.
  • Step 3: Incoming materials stored in pharmaceutical warehouse–quarantine status.
  • Step 4: Sample incoming materials based on defined sampling plan.
  • Step 5: Submit incoming materials for testing
  • Step 6: Receive and evaluate test results
  • Step 7: Transfer tested materials to appropriate status areas (at this stage, materials will be approved or rejected, with materials on test remaining in quarantine and rejected materials destroyed or returned to the supplier)
  • Step 8: Purified water, steam, nitrogen, and compressed air available in manufacturing area.
  • Step 9: Sample purified water, nitrogen, and compressed air based on defined sampling plan
  • Step 10: Receive and evaluate test results
  • Step 11: Dispense approved incoming materials to manufacturing areas
  • Step 12: Receive and store manufactured and finished products–quarantine status.
  • Step 13: Store tested materials in status areas (at this stage, materials on test are approved or rejected, with materials on test remaining in quarantine and rejected materials returned to manufacturing for rework or destroyed)
  • Step 14: Transfer approved materials to distribution center
  • Step 15: Ship approved materials from distribution center to customer.

Materials system subsections. After the business process is completed, appropriate subsections can be identified. For example, the materials system may include the following distinct subsystems:

  • Incoming materials—sourcing (Step 1)
  • Incoming materials—receipt and storage (Steps 2–7)
  • Purified water and compressed gases–material maintenance (Steps 8–10)
  • Dispensing—for future manufacturing (Step 11)
  • Finished products—storage (Steps 12–13)
  • Finished products—distribution (Steps 14–15).


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