Management of SOP’s Lifecycle in Pharma Industry | Part I

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Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company.

Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs.

SOP management refers to the systematic process of creating, implementing, reviewing and maintaining these procedures during their lifecycle.

Having well-defined and well maintained SOPs helps pharmaceutical companies consistently carry out routine operations, improve process efficiency, have uniform performance, as well as onboard new employees effectively.

An SOP is used to streamline the pharmaceutical Quality Management System (PQMS) processes, contributing to uniform and high product quality and safety.


Here are some reasons why SOPs are so important in the pharmaceutical industry:

  1. Compliance With Regulations
  2. Ensure the quality and safety of pharmaceutical products by providing clear instructions on performing tasks.
  3. Improve Efficiency
  4. Transfer Knowledge


Different regulations and standards are applicable depending on the market in which companies operate.

The FDA 21CFR Part 211 defines SOPs as written procedures describing how to perform specific tasks or operations in producing pharmaceutical products. They are designed to ensure drug products’ identity, strength, quality, and purity.

For EMA, the SOP refers to organized and easily verifiable instructions for operations.
According to EudraLex Volume 4 Good Manufacturing Practices (GMP) Chapter 4, they should be written in an imperative mandatory style.

According to the WHO guide to GMP requirements, SOPs are authorized written procedures providing general instructions for various operations, such as equipment operation, maintenance, cleaning, validation, and inspection.

ISO specifies procedures as ways to carry out activities or processes. They ensure that work is done consistently and to the required quality standards, as per ISO 9001:2015 for quality management systems.


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Resource Person: BARBARA PIROLA

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