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

A SOP is a document that provides high-level guidelines for a process. There are different types of SOPs in the pharmaceutical industry.

  • Training SOP: Outlines training procedures, ensuring employees have the necessary knowledge and skills to perform their tasks.
  • Safety SOP: Specifies the steps involved in ensuring the safety of employees and drug products.
  • Product Distribution SOP: Governs the distribution and transportation of pharmaceutical products.
  • Cleaning SOP: Provides instructions for cleaning and sanitization processes within the pharmaceutical facility.
  • Production SOP: Covers the step-by-step procedures for drug manufacturing.
  • Equipment Maintenance SOP: Outlines the steps in maintaining and calibrating critical equipment.
  • Quality Control SOP: Defines the steps involved in testing pharmaceutical products to ensure they meet established quality standards specifications.

To be most effective, standard operating procedures should be succinct, intuitive, easy to navigate, traceable, and regularly approved.

To ensure compliance and traceability to a qualified state are achieved, companies should make approved standard operating procedures traceable and confirm they have an audit trail.

Revisions should be made only when changes occur to the process or the procedural steps, or when a review is compulsory.

Nonprocedural changes—such as inconsequential typographical errors and logo changes—should be noted by the standard operating procedure owner and only added to standard operating procedures during subsequent revisions.

Standard operating procedures should be hard copies or noneditable files that are controlled and archived in a secure location.

The apparent simplicity of high-quality standard operating procedures belies the effort and cost of producing and editing them.

To prevent standard operating procedures from becoming bloated, one solution is to adopt independent parent standard operating procedures, child standard operating procedures, and annexures.

The advantage of using a parent document and child documents is that when subcategories change or need to be revised, the focus is limited to discrete standard operating procedures or attachments.

Consequently, retraining cost is lower because it is specific to the subcategory rather than the standard operating procedure in general.

When judiciously used in standard operating procedures, images can help personnel understand a process.

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Resource Person: BARBARA PIROLA

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