Compliance by Design and Compliance Master Plan - Pharmaceutical Technology

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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


Table III: Materials system subsections (A is approved, R is rejected, Q is quarantine).
Materials system subsections are illustrated in Table III. Detailed business processes should be specified for all subsections.


Table IV: Materials system—sourcing subsection.
Subsection analysis and evaluation. Each materials system subsection should be described and analyzed regarding objectives and successful system attributes. Critical activities, potential variation affecting performance, and related factors should be identified, and a detailed business process should be developed for each subsection. Gaps and improvement projects may be identified as well, and a CAPA project may be committed based on risk. Adequacy of procedures should be reviewed. Table IV describes the sourcing subsection of the materials quality system. This analysis should be completed for all identified subsections within the quality system.

Performance measurement. Methods to quantify and document the performance of the respective subsections are identified. For example, this would include compiling and reviewing quality audits and vendors, obtaining and reviewing test results of all materials from individual vendors are reviewed, monitoring lag time between order and receipt of materials, tracking and trending test data for high-risk incoming materials, reviewing drug dispensing errors for dispensing technicians; and reviewing time delays between material request and material dispensing. Each of these actions is part of ensuring quality system performance.


Table V: Compliance master plan—materials system components.
CMP documentation. All of the business processes and subsections should be documented in the materials system section of the CMP. Table V generally describes the materials system chapter in the CMP. This chapter could be updated as needed to maintain usefulness (i.e., a site having frequent audits might choose to update the CMP every quarter, while other sites may update on an annual basis).

The practicalities of CbD implementation

The decision to implement a CbD program in a manufacturing site is a major decision. Significant commitment including self-inspection of functional areas is involved. Self-inspection may be painful depending on the status of the area. Success in implementing a new program often lies in the approach to implementation; it is not the same as installation of equipment. Personnel are involved, and attitudes may need to change.

To successfully implement CbD (9), one needs to first obtain management commitment. Management must demonstrate that implementation of the CbD approach is not just another "buzzword" program, but rather, a real approach to improving compliance.

Second, a company might consider a pilot program. Select a single section within a quality system to initiate the program, and select a "stand-alone" function having minimal complex interactions. Clearly define the scope, objectives, and criteria for measuring success. For example, select a single laboratory within the analytical function, or select the annual product review group that accesses data and prepares reports.

Third, be sure to involve only interested people or, minimally, people with an open mind as to the value of the change. This third implementation strategy includes the following:

  • Train only those involved on the program
  • Listen to the feedback and suggestions of those involved, including making adjustments and improvements as necessary
  • Expect mistakes and problems and learn from those mistakes
  • Conduct periodic review sessions to monitor progress, make adjustments, and listen to participants
  • Celebrate successes
  • Add new areas to be implemented as success is proven with prior areas
  • Include and train new personnel as success is demonstrated and the program expands
  • Incorporate the CbD and CMP system into the company culture, including making the program the normal way of doing business.

When implementing a QbD program, companies should be careful to avoid implementing multiple systems or the entire program all at once. Training should be initially limited to only those personnel directly involved with the program. Participation of personnel should be based on interest and should not be forced upon those personnel that may oppose change. Reasonable deadlines should be set, and the program should be given time to be implemented. In other words, do not terminate the project at the first sign of failure.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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