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SOP Documentation and continuity

Standard Operating Procedure (SOP) Development

Procedures people actually use. And that pass inspections. A poorly written SOP is almost as dangerous as having no SOP: ambiguities and incomplete steps cause deviations instead of preventing them. We develop clear, coded procedures with a controlled life cycle that your staff actually use and that genuinely transfer knowledge.

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  • 21 CFR 211.100
  • EU GMP Chapter 4
  • ICH Q10
  • ISO 9001 §7.5
DRP · SOPIn control

Signals

When do you need it?

  1. Staff don't follow proceduresBecause they're long, ambiguous or don't reflect how the work is done.
  2. There are human-error deviationsAnd the root cause always ends up being an unclear procedure.
  3. There's no document management systemEach department codes, versions and distributes documents its own way.
  4. You're preparing for a certification or inspectionAnd you need to close documentation gaps fast.

Approach

SOPs that work in practice

We write with the people who perform the task, not just for the auditor. Every step is numbered, verifiable and unambiguous, with responsibilities assigned by role and defined records.

Every SOP we develop includes a controlled header (code, version, effective date, next review, owner), its ten mandatory sections and a complete life cycle: drafting, technical and regulatory review, approval, controlled distribution, training, periodic review and retirement.

We don't write to check a box. We write so the procedure gets followed.

DRP Assurance · Somos Pharma

How we do it

Service stages

  1. 01DiagnosisGap analysis of the documentation structure against GMP.
  2. 02SystemCoding, hierarchy and master template.
  3. 03DraftingSOPs with technical and regulatory review.
  4. 04ApprovalWorkflow, controlled distribution and effective date.
  5. 05Go-liveTraining, read-and-sign, and periodic review.

Regulatory framework

What the regulations require, point by point.

These are the references we work with for this service. We apply the ones that fit your market and your type of product.

FDA 21 CFR Part 211 (cGMP)

  • §211.100Written procedures and deviations: requires approved SOPs for production and process control.
  • §211.68 · §211.160 · §211.192Automatic equipment, laboratory requirements and production record review.
  • 21 CFR Part 11When SOPs are managed in an electronic system.

Deliverables

What you get.

Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.

  1. Documentation gap analysisAssessment of the existing structure against the regulations that apply to you.
  2. Coding system and hierarchyPolicies, SOPs, work instructions, forms and records.
  3. Master SOP templateControlled header and 10 mandatory sections.
  4. Specific SOPs developedStep by step, by role, with associated records.
  5. Document Control ProcedureThe SOP on SOPs: the entire document life cycle.
  6. Team trainingUse, management and updating of the document system.

FAQ

What clients ask before we start

What sections does an SOP need under GMP?

Purpose, scope, responsibilities, definitions, materials and equipment, procedure, associated records, references, revision history, and signatures for preparation, review and approval.

How often should an SOP be reviewed?

Typically every 2 to 3 years, or sooner if there's a significant change. Your Document Control Procedure defines it for your organization.

Can you work from our current SOPs?

Yes. The gap analysis identifies what stays, what gets rewritten and what's missing, so you don't start from scratch.

Works well with

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Next step

Be ready for your next
regulatory challenge.

Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.

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