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Question of the Week | GMP-Verlag

What are the General Requirements for Standard Documents?

  • Question of the Week

Standard documents are comprehensive descriptions of activities. They are required for all GxP-relevant processes. Standardised operating procedures (SOPs) are the most common types of documents. Qualification or validation plans as well as specifications, manufacturing instructions, processing, packaging, and testing procedures are also among the standard documents. 

Standard documents must meet the following requirements:

  • clearly and unambiguously formulated
  • understandable (consider the language of the employees!)
  • accurate
  • easily accessible or retrievable at any time

[GMP:KnowHow Pharma Logistics (GDP), Chapter 4.2]

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