Pharmaceutical SOP & GMP Writing
Budget: ₹1,500 – ₹12,500 INR
I need clear, audit-ready documentation that brings our pharmaceutical manufacturing area fully in line with regulatory expectations. The scope covers two distinct yet interlinked deliverables: a master Good Manufacturing Practice (GMP) manual and a suite of Standard Operating Procedures (SOPs) that drill down into each step of our manufacturing processes.
The GMP manual should outline the overarching quality framework, referencing current FDA, EMA and WHO guidelines where relevant. Each associated SOP must:
• Map the entire manufacturing workflow from raw material receipt through finished-product release.
• Define responsibilities, equipment use, in-process checks, and critical control points.
• Specify record-keeping templates that tie back to the GMP manual for traceability.
I will provide our current drafts, equipment lists and process flow diagrams; you will enhance, restructure or rewrite them so they read as one consistent, compliant set. Your experience with pharmaceutical documentation, ISO 9001 or ICH Q7 terminology, and familiarity with electronic document control systems (e.g., MasterControl, Veeva) will be highly valued.
Deliverables are considered accepted once they pass an internal quality review for regulatory alignment, clarity, and ease of implementation on the shop floor.
The GMP manual should outline the overarching quality framework, referencing current FDA, EMA and WHO guidelines where relevant. Each associated SOP must:
• Map the entire manufacturing workflow from raw material receipt through finished-product release.
• Define responsibilities, equipment use, in-process checks, and critical control points.
• Specify record-keeping templates that tie back to the GMP manual for traceability.
I will provide our current drafts, equipment lists and process flow diagrams; you will enhance, restructure or rewrite them so they read as one consistent, compliant set. Your experience with pharmaceutical documentation, ISO 9001 or ICH Q7 terminology, and familiarity with electronic document control systems (e.g., MasterControl, Veeva) will be highly valued.
Deliverables are considered accepted once they pass an internal quality review for regulatory alignment, clarity, and ease of implementation on the shop floor.