HANDLING THE OUT OF SPECIFICATION (OOS) RESULTS IN PHARMACEUTICAL/ BIOPHARMACEUTICAL INDUSTRIES FOR COMPLIANCE – A HOLISTIC REVIEW

  • Seetha ram Kotra Department of Biotechnology Acharya Nagarjuna University Guntur
  • Suresh Chavvakula Department of Biochemistry, Adhiparasakthi College of Sciences, Kalavai–632506
  • Pardhasaradhi Mathi Zenotech Laboratories Bioloigics API, Shameerpet, Medchal, Malkajgiri Dist–500101
  • Mutyala Rao Chanda Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510
  • Yathish M Thimmareddy Department of Microbiology P.G Centre, Kuvempu University, Davangere–577004,
  • Deva Malleswaraiah Department of Biochemistry, S.V. Degree & P.G College, Kadapa–516003
  • Sandeep Pathak Department of Microbiology, Punjab University, Chandigarh – 160014
  • Anjali Kumari Chillara Department of Microbiology, Acharya Nagarjuna University, Guntur–522510
  • Venugopala Rao Puli Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510
  • Jawahar Babu Peravali Department of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur–522002.
Keywords: Out of specification, intimation to QA, laboratory investigation, full length investigation, root cause, impact assessment, corrective and preventive action, closure

Abstract

Handling of written operational procedures is mandatory in pharma/biopharma industries in view of, to carry out activities for compliance. Out of all these procedures, handling of Out Of Specification (OOS) results attracted the attention of pharma/biopharma industrialists. To investigate the OOS result, an operating procedure should be in place. If any result found out of specification that should be investigated. The source of the OOS result should be identified either as an aberration of the measurement process i.e., laboratory error or an aberration of the manufacturing process. Phase I investigation (laboratory investigation) should include an initial assessment of the accuracy of the laboratory's data which may occur from instrument, reagent, reference standard, environment condition, test method, analyst and calculation within laboratory. Phase II investigation (full-scale OOS investigation) consist of a production/ user department process review and/or additional laboratory investigation. The written procedure should give guidance on the number of retests/ resamples permitted. After impact assessment of OOS on product/ process, appropriate CAPA to be initiated to avoid reoccurrences. This is the first reported and ideal form of handling the out of specification results in different pharmaceutical/ biopharmaceutical industries across the world.

Author Biographies

Seetha ram Kotra, Department of Biotechnology Acharya Nagarjuna University Guntur
Department of Biotechnology Acharya Nagarjuna University Guntur
Suresh Chavvakula , Department of Biochemistry, Adhiparasakthi College of Sciences, Kalavai–632506

Department of Biochemistry, Adhiparasakthi College of Sciences, Kalavai–632506

Pardhasaradhi Mathi, Zenotech Laboratories Bioloigics API, Shameerpet, Medchal, Malkajgiri Dist–500101

Zenotech Laboratories Bioloigics API, Shameerpet, Medchal, Malkajgiri Dist–500101

Mutyala Rao Chanda, Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510

Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510

Yathish M Thimmareddy, Department of Microbiology P.G Centre, Kuvempu University, Davangere–577004,

Department of Microbiology P.G Centre, Kuvempu University, Davangere–577004,

Deva Malleswaraiah , Department of Biochemistry, S.V. Degree & P.G College, Kadapa–516003

Department of Biochemistry, S.V. Degree & P.G College, Kadapa–516003

Sandeep Pathak, Department of Microbiology, Punjab University, Chandigarh – 160014

Department of Microbiology, Punjab University, Chandigarh – 160014

Anjali Kumari Chillara, Department of Microbiology, Acharya Nagarjuna University, Guntur–522510

Department of Microbiology, Acharya Nagarjuna University, Guntur–522510

Venugopala Rao Puli, Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510

Department of Biotechnology, Acharya Nagarjuna University, Guntur–522510

Jawahar Babu Peravali, Department of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur–522002.

Department of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur–522002.

References

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2. https://www.pharmaguideline.com/2010/03/sop-for-out-of-specification-oos.html
3. Seetha Ram K, Rajeswari Ramayanam, Sudheer Reddy B, Lavanya Reddy N, Ganesh T, Daya T, Sandhya P, PVD Sowjanya Kumari. Deviation Management System – A Boon in Industrial Quality Sciences for Compliance. IJUNESST. 2018; 11(3): 15-26.
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Published
2019-09-30
How to Cite
Kotra, S. ram, Suresh Chavvakula, Pardhasaradhi Mathi, Mutyala Rao Chanda, Yathish M Thimmareddy, Deva Malleswaraiah, Sandeep Pathak, Anjali Kumari Chillara, Venugopala Rao Puli, & Jawahar Babu Peravali. (2019). HANDLING THE OUT OF SPECIFICATION (OOS) RESULTS IN PHARMACEUTICAL/ BIOPHARMACEUTICAL INDUSTRIES FOR COMPLIANCE – A HOLISTIC REVIEW. Mintage Journal of Pharmaceutical and Medical Sciences (ISSN: 2320-3315), 1-4. Retrieved from http://mjpms.in/index.php/mjpms/article/view/478
Section
Short Communication(s)