Standard Operating Procedure (SOP) Development
A poorly written SOP is almost as dangerous as having no SOP at all. We develop procedures that staff actually use, that pass inspections and that transfer real knowledge.
SOPs that work in practice
Standard Operating Procedures are the backbone of any pharmaceutical quality system. However, many organizations have SOPs that were written to meet a regulatory requirement but that staff do not use, do not understand or cannot follow in practice.
At DRP Assurance we develop SOPs under the highest international GMP standards, with a practical approach: clear, unambiguous procedures that truly guide operations and withstand the scrutiny of any regulatory audit.
Key Benefits
Document gap analysis
Complete assessment of the existing document structure vs. GMP requirements.
Coding system
Design of the numbering, classification and document coding system.
Master templates
Templates aligned to FDA, EU GMP, WHO and the client's local regulations.
Operational SOPs
Step-by-step procedures, without ambiguity, with clear acceptance criteria.
Document control
The SOP of SOPs: document lifecycle management procedure.
Training
Team training on the use, management and update of the document system.
Our Process
Document assessment
We evaluate the current structure, identify gaps vs. applicable GMP requirements.
System design
We define coding, document hierarchy and master templates.
SOP development
We write each procedure with technical and regulatory review.
Approval cycle
Drafting, review, approval and controlled distribution.
Training and Go-Live
We train staff and establish the periodic review program.
Service Features
Regulatory Framework
- FDA 21 CFR Part 211 (cGMP)
- ICH Q10 — Pharmaceutical Quality System
- EU GMP Chapter 4 — Documentation
- WHO TRS — Good Manufacturing Practices
- ISO 9001:2015 — Documented information
- ANMAT Disposition 3602/2019
Deliverables
- Document assessment (gap analysis)
- Coding system and hierarchy
- Master SOP template
- Specific SOPs developed
- Document Control Procedure
- Training and training materials
Why choose DRP for SOP Development?
Multi-regulatory expertise
We know the documentation requirements of FDA, EMA, ANMAT, ANVISA and WHO. Every SOP we develop withstands international audits.
SOPs that get used
We don't write to comply. We write so that staff actually follow the procedure, eliminating ambiguities and unnecessary steps.
Real knowledge transfer
We leave your team trained to maintain, update and version the document system autonomously.
Can your SOPs withstand an inspection?
Find out if your document structure meets the regulatory standards that apply to you.
REQUEST DOCUMENT ASSESSMENT