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Development of a Quantitative Recombinase Polymerase Amplification Assay with an Internal Positive Control
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Polymerase Chain Reaction/Rapid Methods Are Gaining a Foothold in Developing Countries.

Suzan Mohammed Ragheb1, Luis Jimenez2

  • 1Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries, Cairo, Egypt; and Biology and Horticulture Department, Bergen Community College, Paramus, NJ, USA drsuzanragheb@yahoo.com.

PDA Journal of Pharmaceutical Science and Technology
|September 5, 2014
PubMed
Summary

Implementing polymerase chain reaction (PCR) for pharmaceutical quality control in developing nations requires careful planning. Key considerations include laboratory setup, equipment, reagents, trained personnel, and quality assurance for regulatory acceptance.

Keywords:
Microbial ContaminationPharmaceuticalsPolymerase chain reactionRapid microbiological methodsTechnology transferValidation

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Area of Science:

  • Pharmaceutical Microbiology
  • Molecular Diagnostics

Background:

  • Microbial contamination detection is crucial for pharmaceutical safety, stability, and potency.
  • Rapid microbiological methods, like polymerase chain reaction (PCR), are established in clinical and food analysis but underutilized in pharmaceuticals.
  • Challenges exist in adopting PCR for pharmaceutical quality control, especially in developing countries.

Conclusions:

  • The adoption of PCR in pharmaceutical quality control in developing countries is feasible but requires strategic planning and investment.
  • Compliance with good manufacturing practices (GMP) is paramount for sensitive and robust PCR assays.
  • Pharmaceutical firms must consider these factors to facilitate regulatory approval and broad application of PCR technology.