SOPs that sound like your QMS, not a template.

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Northbridge Distribution Ltd

Temperature excursion management in transit

Document no.
SOP-QA-014
Revision
0.1
Status
Draft
Effective
Pending approval

1 Purpose

This procedure defines how temperature excursions during the transport of medicinal products are detected, assessed and recorded, in line with EU-GDP-2013, Chapter 9.

2 Scope

Applies to all temperature-controlled consignments handled under the site’s WDA(H) licence, including those moved by contracted carriers.

3 Responsibilities

The Warehouse Manager reports every excursion within one working day. The Responsible Person decides product disposition.

Prepared · SwiftQMS draft

Reviewed

Approved

Illustrative specimen. The company and procedure are fictional. Signature lines stay blank until a qualified person reviews and approves.

Drafts cite only from a curated, verified reference set

  • EU GMP, EudraLex Vol. 4
  • EU GDP 2013/C 343/01
  • MHRA Orange Guide
  • ICH Q9 and Q10
  • Annex 11
  • Annex 15
  • Annex 16
  • 21 CFR 210 and 211
  • ICH Q7
  • ISO 9001, cl. 7.5

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  1. 01

    Tell it about your operation once

    Eighteen questions in four sections capture your licences, products, QMS maturity and numbering conventions. Every later draft starts from this profile.

    What type of organisation are you?
    Wholesale distributor
    Which regulatory frameworks apply?
    UK GDP · EU GDP
    Do you hold any licences?
    WDA(H)
    Document numbering convention
    SOP-QA-###
  2. 02

    Describe the document you need

    Pick a document type and write a plain-language brief. SwiftQMS assembles a structured draft from your profile, your brief and its regulatory knowledge.

    PolicySOPWork instruction

    Temperature excursions during transport. Who reports, how we assess product impact, and when the RP decides disposition.

  3. 03

    Review, refine and take it to sign-off

    The draft is yours to challenge. Your qualified reviewer stays in charge of what is accurate, what is approved and what is released.

    Every draft is marked Draft and arrives with blank signature lines. Refine it with follow-up prompts, then take the Word file into your own document control system.

    SOP-QA-014-rev-0.1.docx

The three layers of a QMS, drafted in one consistent voice.

Each layer inherits the same company profile, so a policy, the SOPs beneath it and the work instructions under those all agree with each other.

  1. POL-QA-001Level 1 · Why

    Quality policy

    Quality policy statement

    Sets out what the organisation commits to, and how senior management stays accountable for the quality system.

    EU-GMP-Ch1 · ICH-Q10

  2. SOP-QA-014Level 2 · Who and when

    Standard operating procedure

    Document control and revision of controlled documents

    Defines who prepares, reviews and approves each controlled document, and when a revision is required.

    EU-GMP-Ch4 · ISO-9001 cl. 7.5

  3. WI-WH-022Level 3 · How

    Work instruction

    Packing a 2 to 8 °C shipper for dispatch

    Gives the warehouse operator each step, in order, with the checks that must be recorded before release.

    EU-GDP-2013 · MHRA-GDP

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SwiftQMS does

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  • Cites only from a curated, verified reference set
  • Matches references to your stated framework, so EU-only sites are not cited FDA rules
  • Uses Anthropic's Zero Data Retention API configuration, with UK and EU data assumptions

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The goal is not more documents. It is better evidence, reviewed by the right person.

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  • Policies, SOPs and work instructions
  • Editable Word export
  • Built by a practising RP/RPi