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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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A proposal for a quality system for herbal products.

Sharadwata Pan1, Abhishek Neeraj, Kumar Shivam Srivastava

  • 1Department of Chemical Engineering, Indian Institute of Technology Bombay, Mumbai, 400076, India.

Journal of Pharmaceutical Sciences
|October 15, 2013
PubMed
Summary

Global demand for botanicals is rising, yet traditional plant medicines face quality challenges. Implementing Hazard Analysis and Critical Control Point (HACCP) and Process Analytical Technology (PAT) can improve phytodrug manufacturing and global acceptance.

Keywords:
bioanalysisbiopharmaceuticals characterizationcritical control point; Gingko bilobaherbal productsprocess analytical technologyquality by designregulatory sciencespectroscopytraditional medicine

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Area of Science:

  • Pharmacognosy
  • Pharmaceutical Manufacturing
  • Quality Control

Background:

  • Developing countries depend on plant-derived medicines due to lower costs and less stringent regulations compared to modern medicine.
  • Modern medicine requires rigorous Good Manufacturing Practices (GMP) and quality control, posing a challenge for traditional phytodrugs.
  • Key barriers to widespread adoption of traditional plant medicines include inadequate quality assurance, supply chain traceability issues, and poor identification of active molecular compounds.

Purpose of the Study:

  • To identify critical factors hindering the global acceptance and credibility of phytodrugs.
  • To propose actionable solutions for the phytodrug industry to enhance product quality and market reach.
  • To establish a clearer link between raw materials, manufacturing processes, and final product quality in phytotherapeutic development.

Main Methods:

  • Review of current challenges in traditional plant medicine manufacturing and quality assurance.
  • Analysis of factors affecting traceability and identification of therapeutic compounds.
  • Proposal of implementing Hazard Analysis and Critical Control Point (HACCP) and Process Analytical Technology (PAT) in phytodrug production.

Main Results:

  • Identified lack of quality assurance, supply chain traceability, and molecular identification as major impediments.
  • Highlighted the absence of a clear, causative relationship between raw materials, manufacturing, and final product quality.
  • Proposed HACCP and PAT as essential tools for improving manufacturing consistency and product reliability.

Conclusions:

  • Implementing robust quality management systems like HACCP is crucial for the phytodrug industry.
  • Process Analytical Technology (PAT) can ensure minimal deviation and enhance the consistency of phytotherapeutic manufacturing.
  • These technological and procedural enhancements are vital for increasing the global reach and credibility of plant-derived medicines.