1. ASSESSING GMP v.  CLINICAL PHASE

• Development QA - Biologics Early Phase GMP will jointly create phase-appropriate workflows with quality leadership, then train staff.
  

• Clear data collection is key to future communication of successful early phase work.

2. BUILDING QUALITY SYSTEMS

•  Development QA - Biologics Early Phase GMP will explain how accountability proactively builds data integrity, aiding review of lab & mfg records.

• Thorough investigations yield traceable easy-to-share clinical manufacture data.
  

3. TRACK AND TREND IMPROVEMENTS

• Quality Metrics shared regularly with upper management.  Examples:  numbers of open investigations, numbers of lots released.
  

• Know before you go to partners and investors.
  

4. CREATING QUALITY MANUAL

• Quality Policy provides overview of current procedures that guide GMP decision-making.

5. ON TO LATE PHASE III

• Integrating the GMP quality system into development built product reliability, the basis of quality by design, QbD. 
  

• Linking development reports to early phase work, to process validations, and to late Phase III clinical trials boosted PAI Readiness.

  1. ASSESSING QUALITY INCIDENT

• Development QA - Biologics Early Phase GMP will facilitate company quality leadership and CMO in assessing GMP quality incident. 
  

• Goal is to chart an objective approach consistent with quality agreements, risk, and SOPs.

2. BUILDING CONSENSUS for ACTION

•  Development QA - Biologics Early Phase GMP will facilitate examining the thoroughness of  documentation and data integrity for information required to make a decision. 
  

• Goal is to identify and support decision-makers.
  

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3. DRIVING for CONCLUSION

• Frequent, regular meetings on progress, with metrics on updates and accountability shared regularly with upper management.  Examples:  tracking draft circulation, final sign-offs.

• Goal is to maintain visibility and momentum.

4. ARRIVING at RESOLUTION

• With investigation decision on contracted work,
  

• Goal is to deliver final investigation report.

5. UPDATING  QUALITY DOCUMENTS

• Quality Agreement, CMO methods, client procedures, etc., may require updates, although results may be reported prior to updates.

• Goal is to ensure completion of quality updates.