• Developing Future Delivery Models For ATMPs: Practical Considerations

    With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.

  • 7 Rules For Properly Interpreting Control Charts

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

  • Cleaning Verification & Validation Of Multipurpose API Plants: 9 Rules To Follow

    Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.

  • Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?

    The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.

  • Certifying Pharmaceutical Exports: A Roadmap To EMA’s Certificate Of Medicinal Product

    In Part 1 of this two-part series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product (CPP). Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product (CMP) issued by the European Medicines Agency (EMA).

  • Establishing Best Practices For Risk-Based Environmental Monitoring Of Modern Drug Product Facilities

    Designing an EM program is a relatively complex task; facilities vary considerably and there is inadequate specific guidance on how to design EM programs and no single standard risk assessment methodology exists.

  • Certifying Pharma Exports: Intro To FDA’s Certificate Of Pharmaceutical Product

    When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, we discuss the requirements for exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA. 

  • Quality Management Review — Benchmarking Quantitatively!

    Typically, when the cost of quality is depicted, it is split into “cost of control” and “cost of failure of control.” At the next level of detail, the costs of prevention and appraisal appear on one side and the costs of internal failure and external failure on the other side. How to interpret and implement these buckets at the tactical level is often left to personal imagination.


  • The Importance Of An Analytical Testing Strategy For Combination Products

    As combination products evolve and a preference for self-administration systems such as prefilled syringes, auto-injectors, and pen injectors commercialize, there is a need to ensure proper testing of both the primary and secondary components in compliance with regulatory guidelines. The combination product development process to focus on the user-friendliness, or human factors, of self-administration systems, very often involves new and innovative drug products. One crucial aspect of this process focuses on regulatory submission. A foundational point that tends to be overlooked, and required for regulatory submission, is the analytical testing strategy that supports the combination product development process, whether at the stages of concept, feasibility, development, or product release.

  • Process Characterization: Ready For The FDA?

    Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.

  • Product Development For An Oral Solid Dosage Using Continuous Manufacturing

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

  • Using In-Line Sensors For Real-Time Control

    There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.




This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. To that end, each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique. Additionally, each technique demonstrates the linkage to risk to help demonstrate “a high degree of assurance.”

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