Abstract

Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do occur knowingly or unknowingly. A deviation needs to be addressed and investigated with proper corrective actions and preventive actions (CAPA) to avoid recurrence. This is a regulatory requirement too. Deviation can result from malfunctioning of equipment, non-conforming materials and human errors as well. In this article, we have tried to outline various types, with few examples and a brief handling procedure for handling deviations efficiently.

Original languageEnglish
Pages (from-to)340-342
Number of pages3
JournalResearch Journal of Pharmacy and Technology
Volume7
Issue number3
Publication statusPublished - 2014

Fingerprint

Drug Industry
Recurrence
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Cite this

@article{2581e6dd9f7946649f9eac5f4047d2ce,
title = "Process deviations in pharmaceutical industry: Various types, handling procedure and systems",
abstract = "Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do occur knowingly or unknowingly. A deviation needs to be addressed and investigated with proper corrective actions and preventive actions (CAPA) to avoid recurrence. This is a regulatory requirement too. Deviation can result from malfunctioning of equipment, non-conforming materials and human errors as well. In this article, we have tried to outline various types, with few examples and a brief handling procedure for handling deviations efficiently.",
author = "Krishna, {Vamshi T.} and Lalit Kumar and {Sreenivasa Reddy}, M. and Muddukrishna, {B. S.} and {Girish Pai}, K.",
year = "2014",
language = "English",
volume = "7",
pages = "340--342",
journal = "Research Journal of Pharmacy and Technology",
issn = "0974-3618",
publisher = "A and V Publication",
number = "3",

}

TY - JOUR

T1 - Process deviations in pharmaceutical industry

T2 - Various types, handling procedure and systems

AU - Krishna, Vamshi T.

AU - Kumar, Lalit

AU - Sreenivasa Reddy, M.

AU - Muddukrishna, B. S.

AU - Girish Pai, K.

PY - 2014

Y1 - 2014

N2 - Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do occur knowingly or unknowingly. A deviation needs to be addressed and investigated with proper corrective actions and preventive actions (CAPA) to avoid recurrence. This is a regulatory requirement too. Deviation can result from malfunctioning of equipment, non-conforming materials and human errors as well. In this article, we have tried to outline various types, with few examples and a brief handling procedure for handling deviations efficiently.

AB - Standard operating procedures (SOPs) form the backbone of any pharmaceutical industry. It states the procedure to be followed for each and every activity that is carried out in the pharmaceutical industry. All the staffs are trained on each SOP. SOPs state the procedure to be followed, dos and don'ts etc. However most of the times, deviations do occur knowingly or unknowingly. A deviation needs to be addressed and investigated with proper corrective actions and preventive actions (CAPA) to avoid recurrence. This is a regulatory requirement too. Deviation can result from malfunctioning of equipment, non-conforming materials and human errors as well. In this article, we have tried to outline various types, with few examples and a brief handling procedure for handling deviations efficiently.

UR - http://www.scopus.com/inward/record.url?scp=84903446186&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84903446186&partnerID=8YFLogxK

M3 - Review article

VL - 7

SP - 340

EP - 342

JO - Research Journal of Pharmacy and Technology

JF - Research Journal of Pharmacy and Technology

SN - 0974-3618

IS - 3

ER -