DOI: 10.21276/ajptr
Sat, 25 May 2019

Process Capability and Six Sigma: A Necessity of Pharmaceutical Industry

Paaras Gupta1*, Ankita Kapoor1

1. School of Pharmacy and Emerging Sciences, Baddi University of Emerging Sciences and Technology, Makhnumajra Baddi, Distt. Solan, H.P. -173205, India.


The need of the day is to produce the product that meets customer requirements. As pharmaceuticals are related to health care this should be vital part of industry to produce a product such as tablets, capsules, ointments, creams, gels and emulsions etc. with minimum variation satisfying the needs of customer. Customer requirements are translated into ‘Critical to Quality’ (CTQ) characteristics of the products that they are about to produce by the formulation scientists.  As example, hardness, thickness, uniformity of weight, assay, dissolution etc are CTQ characteristics of tablets, Content uniformity, viscosity, density are CTQ characteristics of a gel etc.  There are various sources of variation which can be monitored by the Quality by Design i.e., QbD approach. Process should be monitored and controlled by using statistical process control which includes six sigma approach, process capability and control charts. Some of the more frequently used indices are Cp and Cpk. Cp represents process capability while Cpk is the process capability index which are determined between USL and LSL which signifies upper specification limit and lower specification limit. Cpk of at least 1.33 is desired, and 1.5 is excellent and if there are not more than 3.4 defects per million units, then six sigma is achieved.

Keywords: Quality by design, Cpk, Cp, Customer requirements, variation

[PDF]   Viewed: 1093   Downloaded: 239
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter