A Review on Life Cycle Management Approach on Asset Qualification

  • Mamta R. Mali Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.
  • O.G. Bhusnure Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.
  • Shrikrishna T. Mule Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.
  • S.S. Waghmare Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Abstract

All equipment’s used in the production of products shall be properly Validated, Qualified and Calibrated to demonstrate that it is suitable for its intended purpose. Qualification is an important aspect of the pharmaceutical quality system. When the equipment is properly qualified, verified and maintained, there is the possibility of Consistent performance of the equipment. A well designed qualification program saves valuable time and cost. Qualification is called a cyclic process because it is a never ending process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification (Not documented it means not done).  The current programs and procedures of equipment qualification used within any pharmaceutical and bioscience industry are based on ‘regulatory requirements’, ‘voluntary standards’, ‘vendor practices’, and ‘industry practices’. The output is considerable variation in the way any pharmaceutical and biotechnological companies approach for the laboratory equipment. The lifecycle management approach of equipment qualification covers entire life cycle for the specification, design, manufacturing, installation, commissioning, qualification (4Qs Model DQ, IQ, OQ, PQ), operation & maintenance of equipment in a risk based life cycle management approach. The goal of any regulated pharmaceutical and bioscience company is to provide reliable and valid data suitable for its intended purpose. Main goal of equipment qualification is to form the basis for written procedures for production and process control which are designed to assure that the drug products have the SISPQ (Safety, Identity, Strength, Purity and Quality)


Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ (Safety, Identity, Strength, Purity and Quality)

Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ

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Author Biographies

Mamta R. Mali, Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

O.G. Bhusnure, Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Shrikrishna T. Mule, Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

S.S. Waghmare, Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College(Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India- 413512.

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Mali MR, Bhusnure O, Mule S, Waghmare S. A Review on Life Cycle Management Approach on Asset Qualification. JDDT [Internet]. 15Jul.2020 [cited 7Aug.2020];10(4):253-9. Available from: http://jddtonline.info/index.php/jddt/article/view/4146