You will get Develop a GMP-Compliant Deviation SOP to Enhance Pharmaceutical Quality
Project details
I will develop a GMP-compliant Deviation SOP tailored to your pharmaceutical operations, covering identification, documentation, investigation, root cause analysis, risk assessment, CAPA, and closure. The SOP will align with USFDA 21 CFR, EMA, WHO GMP, and internal QMS expectations. You will receive an editable, inspection-ready SOP including deviation classification (planned/unplanned), unique numbering, investigation flow, and recurrence-based change control triggers. A customizable Deviation Report Form (template) is also provided to support real-time documentation and traceability. Optional elements include process flowcharts and CAPA checklists. With 20+ years in QA/RA across top pharma companies, I ensure your deviation system strengthens compliance, quality assurance, and regulatory readiness.
Document Type
ProcedureTopic
Manufacturing, TechnologyLanguage
English, BengaliWhat's included
| Service Tiers |
Starter
$40
|
Standard
$70
|
Advanced
$150
|
|---|---|---|---|
| Delivery Time | 3 days | 5 days | 7 days |
Number of Revisions | 1 | 2 | 3 |
Number of Words | 2000 | 3000 | 4500 |
Number of Technical Illustrations | 0 | 1 | 2 |
Consultation | - | - | |
Proofreading & Editing | |||
Additional Research | - | ||
References & Citations | - | ||
Formatted Style Guide |
Frequently asked questions
About Kartick Chandra
Pharmaceutical QA Consultant | GMP Compliance & Regulatory Expert
Dhaka, Bangladesh - 12:06 am local time
Throughout my career, I have worked in leading pharmaceutical companies like Square Pharmaceuticals, Sun Pharma, and Pfizer.
I can help:
- Deviation management and CAPA
- SOP writing and process documentation
- CTD dossier preparation and regulatory submission (USFDA, EMA)
- GMP audits, internal inspections, and compliance
- Quality risk assessment and change control
- Medicinal Leaflet, Insert & Artwork development
- Method Development & Validation Protocol
- Batch Documentation (BMR & BPR)
- Root Cause Analysis
- Audit Check List
- GMP Gap Analysis
I support pharmaceutical companies in ensuring regulatory readiness, improving quality systems, and achieving global compliance standards.
My approach is compliance-driven, detail-oriented, and aligned with current global regulatory expectations. I am passionate about continuous improvement, maintaining product quality, and ensuring patient safety.
If you’re looking for support in pharmaceutical QA, GMP documentation, regulatory submissions, or audit preparation — I’d be glad to contribute with practical insight and industry-standard solutions.
Steps for completing your project
After purchasing the project, send requirements so Kartick Chandra can start the project.
Delivery time starts when Kartick Chandra receives requirements from you.
Kartick Chandra works on your project following the steps below.
Revisions may occur after the delivery date.
Client Feedback & Revisions
Share draft SOP & Form for review and incorporate revisions as per feedback.