Quality Management System — Documentation and Structure¶

1. Document Hierarchy¶

Level	Document Type	Description	Examples
Level 1	Quality Policy	Overarching quality philosophy and objectives	Quality manual, quality policy statement
Level 2	Standard Operating Procedures (SOPs)	Detailed operational protocols	Equipment operation, cleaning procedures, analytical methods
Level 3	Work Instructions	Step-by-step task-level instructions	Sample preparation, column packing, buffer preparation
Level 4	Forms, Records, Logs	Evidence of execution	Batch records, equipment logs, training records, CoAs

Each batch is assigned a unique lot number: YYYYMM-XXX - YYYY = Year, MM = Month, XXX = Sequential number (e.g., 202607-001)

Record Type	Information Captured	Retention
Raw material receipts	Supplier, lot number, CoA, expiry date	Batch + 2 years
Synthesis batch record	Resin lot, amino acid lots, reagent lots, cycle parameters	Batch + 2 years
Purification batch record	Column used, gradient parameters, fraction collection data	Batch + 2 years
QC test records	Analytical methods, raw data, system suitability, results	Batch + 2 years
Certificate of Analysis	All release test results, signed release	Batch + 2 years
Stability records	Time-point test results (if applicable)	Study + 2 years

Category	Definition	Response	Timeline
Minor	Deviation with no impact on product quality	Corrective action within batch, deviation report	5 business days
Major	Deviation with potential quality impact	Root cause investigation, CAPA, Quality review	10 business days
Critical	Deviation affecting safety or compliance	Full investigation, batch hold, Quality + Management review, CAPA	15 business days

Change Category	Examples	Approval Level
Minor	Equipment part replacement (equivalent), SOP format update	Department head
Major	New equipment, new analytical method, process parameter change	Quality Manager
Critical	Raw material supplier change, manufacturing site change	Management Review