Review of ISPE's Baseline Guide for Oral Solid Dosage Forms - Pharmaceutical Technology

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Review of ISPE's Baseline Guide for Oral Solid Dosage Forms
The author outlines the key concepts of ISPE's recently revised Baseline Pharmaceutical Guide for New and Renovated Facilities. This article is part of a special supplement on Excipients and Solid Dosage.


Pharmaceutical Technology
Issue 34, pp. s6-s12

Control and instrumentation. The guide addresses control-and-instrumentation systems for OSD manufacturing facilities. It focuses on facility and environment controls that affect patient safety and product quality and the major topics that drive decisions regarding the design and setup of process-control systems (PCSs). The objective is to provide design guidance, which results in cost-effective system designs that are capable of being qualified (18).

Control-and-instrumentation systems are used in many facility systems. They may be deemed to affect patient safety and product quality if they control, monitor, or record a critical process parameter or directly affect a critical quality attribute. Components of control-and-instrumentation systems are also considered critical if they come into direct physical contact with the product (18).

The functions of a control-and-instrumentation system may be performed in a single system or by several independent systems. The guide provides specific design advice where possible, but stresses that different operational preferences and priorities influence the preferred solution. The designer needs to consider other relevant design criteria such as safety, reliability, and maintenance. PSC encompass a wide variety of systems such as programmable-logic-controller systems, supervisory-control-and-data-acquisition systems, distributed-control systems, and MESs (18, 21).

Control systems may be complex and validation strategies should be based on a defined risk-based approach. A testing strategy should be based on a predefined estimate of the level of risk, providing traceability and information allowing critical parameters to be determined. The basis of PAT is process understanding and the application of appropriate control strategy for the critical process parameters to ensure the quality of in-process material and final drug products. A robust control system is a key component to support a PAT system implementation (18, 22).

A statistical process control (SPC) may be considered as a precursor to PAT. A control system should assist with:

  • Collecting process data (60% of an SPC implementation)
  • Transferring process data to standard statistical tools
  • Monitoring and using control charts in a batch context.

At the time of this publication, PAT is only in the inception phase. The ability to connect PAT measurement devices with PCSs and to transfer related data to statistical tools is required before a regulatory filing involving PAT.

Other considerations. The ISPE OSD guide provides an overview of considerations for health, safety, and environmental factors and controlled substances (3). The guide summarizes non-CGMP risks that should be considered and provides an overview of the basic technical and procedural approaches that may be used to mitigate these risks (3). In addition to information provided in the guide, project teams should be aware of local requirements and facility policies. The guide outlines the types of non-CGMP information that should be gathered as part of an organization's risk assessment and mitigation process.

Commissioning and qualification guide

In its report, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach, FDA outlined several key goals:

  • Encourage early adoption of new technological advances by the pharmaceutical industry
  • Facilitate industry application of modern quality management techniques, including quality-management-systems and all aspects of pharmaceutical production and QA
  • Encourage implementation of risk-based approaches that focus attention on critical areas (23).

A revision of ISPE's Baseline Guide Volume 5 Commissioning and Qualification is underway. The revisions seeks to support these objectives by describing an efficient and effective design, installation, and verification process that focuses on safeguarding product quality and public health. It is intended that risk management should underpin the specification, design, and verification process, and be applied appropriately at each stage.

As part of this revision, Baseline Guide Volume 5 Commissioning and Qualification is being aligned with ASTM International's standard E2500, which describes a risk- and science-based approach to the specification, design, and verification of manufacturing systems and equipment that have the potential to affect product quality and patient safety.

Acknowledgment

The author would like to acknowledge ISPE for providing information in support of this article.

Richard Denk is director of the pharmaceutical department at Hecht Technologie GmbH, Schirmbeckstrasse 17, 85276 Pfaffenhofen/Ilm, Germany,
, tel. +49 8441 8956 18. He is a contributing writer to the International Society for Pharmaceutical Engineering's (ISPE) Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Oral Solid Dosage Forms, a member of ISPE's Oral Solid Dosage Steering Committee, and co-chair of ISPE's Containment Steering Committee.

References

1. Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009).

2. ICH, Q9 Quality Risk Management (Geneva, Nov. 2005), Sec. 17, Reference 1.

3. "Other Considerations," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE,, Washington, DC, 2nd ed., Nov. 2009), Chapter 10, pp 125–148.

4. "Concepts and Regulatory Philosophy" in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 2, pp 17–21.

5. "Process Support and Utilities," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 6, pp. 89–96.

6. "Risk-Based Approaches to Commissioning and Qualification" in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 11, pp 149–151.

7. "Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General," in Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington DC), Part 210.

8. "Current Good Manufacturing Practice for Finished Pharmaceuticals, "in Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington DC), Part 211.

9. European Commission, Commission Directive 2003/94/EC, "Laying down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use (Brussels, Oct., 2003).

10. European Commission, EudraLex (Rules Governing Medicinal Products in the European Union) Volume 4: EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (Brussels, Oct., 2003).

11. Pharmaceutical Affairs Law (Japan's MHLW, Tokyo), Article. 14.2, paragraph 4.

12. "Regulations for Building and Facilities of Pharmacies," in Pharmaceutical Affairs Law (Japan's MHLW, Tokyo).

13. "Product Protection," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 3, pp 23–30.

14. "Product and Processing," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 4, pp 31–36.

15. "Architectural," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington DC, 2nd ed., Nov. 2009), Chapter 5, pp 67–88.

16 "HVAC, " in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 7, pp 97–113.

17. "Electrical," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 8, pp 115–120.

18. "Control and Instrumentation," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 9, pp 121–124.

19. "Cost Factors in OSD Manufacturing, "Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Appendix 1, 153–155.

20. Baseline Pharmaceutical Engineering Guide–Volume I Active Pharmaceutical Ingredients (ISPE, Washington, DC, 2nd Ed., Apr. 2007).

21. "Control and Instrumentation," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 9, Section 17, Reference 13.

22. "Control and Instrumentation," in Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities–Volume 2 Oral Solid Dosage Forms (ISPE, Washington, DC, 2nd ed., Nov. 2009), Chapter 9, Section 17, Reference 28.

23. FDA, Pharmaceutical CGMPs for the 21st Century–A Risk-Based Approach (Rockville, MD, 2004).


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