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SOPs/SOP-001-Document-Control.md

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+# Standard Operating Procedure: Document Control
+
+| Document ID | SOP-001 |
+|-------------|---------|
+| Title | Document Control |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Pediatric Pharmacy - Quality |
+
+---
+
+## 1. Purpose
+
+To establish a standardized process for the creation, review, approval, distribution, and revision of all pediatric pharmacy Quality Management System (QMS) documents.
+
+## 2. Scope
+
+This procedure applies to all controlled documents within the pediatric pharmacy QMS, including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions (WIs)
+- Forms and Templates
+- Dosing protocols and guidelines
+- Compounding formulations
+- Training materials
+
+## 3. Responsibilities
+
+### 3.1 Quality Manager
+- Oversees the document control system
+- Ensures documents are reviewed and approved appropriately
+- Maintains the master document list
+- Coordinates periodic reviews
+
+### 3.2 Document Owners
+- Initiates creation or revision of documents
+- Ensures technical accuracy and clinical appropriateness
+- Coordinates reviews with subject matter experts
+- Maintains pediatric-specific content accuracy
+
+### 3.3 Approvers
+- Reviews documents for compliance and quality
+- Provides final approval for implementation
+- Ensures pediatric safety considerations are addressed
+
+### 3.4 All Pharmacy Staff
+- Uses only current, approved versions of documents
+- Reports discrepancies or improvement opportunities
+- Follows documented procedures
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Controlled Document | Any document that is part of the QMS and subject to version control |
+| Master Document List | Comprehensive list of all controlled documents |
+| Revision | Any change to a controlled document requiring re-approval |
+| Obsolete Document | Document that is no longer current and has been superseded |
+| Effective Date | Date when a new or revised document becomes active |
+
+## 5. Procedure
+
+### 5.1 Document Creation
+
+1. Document owner identifies need for new document
+2. Selects appropriate template from `/Templates`
+3. Drafts document following standard format
+4. Ensures pediatric-specific considerations are included
+5. Assigns unique document ID according to numbering convention
+6. Routes for technical review
+
+### 5.2 Document Review
+
+1. Subject matter experts review for technical accuracy
+2. Quality Manager reviews for compliance with standards
+3. Clinical pharmacist reviews for pediatric appropriateness
+4. Reviewers provide feedback within 5 business days
+5. Document owner incorporates feedback
+
+### 5.3 Document Approval
+
+1. Document owner submits final version for approval
+2. Approver reviews complete document
+3. Approver signs/dates document or provides approval comment
+4. Quality Manager assigns effective date (minimum 7 days from approval)
+5. Document added to Master Document List
+
+### 5.4 Document Distribution
+
+1. Quality Manager publishes approved document to repository
+2. Notification sent to all affected personnel
+3. Training conducted if required
+4. Old version moved to archive (if revision)
+
+### 5.5 Document Revision
+
+1. Anyone may initiate revision request via change request form
+2. Document owner evaluates need for revision
+3. If approved, follows creation process with new revision number
+4. Revision history table updated with change description
+5. All copies of previous version removed from use
+
+### 5.6 Periodic Review
+
+1. All documents reviewed at least annually
+2. Review verifies:
+   - Content remains accurate and current
+   - Regulatory references are up to date
+   - Pediatric practice standards are current
+   - Process remains effective
+3. Review documented even if no changes made
+4. Documents may be re-approved or revised as needed
+
+### 5.7 Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-DOSE-XXX**: Dosing Verification SOPs
+- **SOP-COMP-XXX**: Compounding SOPs
+- **SOP-CHEMO-XXX**: Chemotherapy SOPs
+- **SOP-SAF-XXX**: Patient Safety SOPs
+- **SOP-CS-XXX**: Controlled Substance SOPs
+- **SOP-INV-XXX**: Inventory SOPs
+- **SOP-GEN-XXX**: General SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms
+- **LOG-XXX**: Logs
+
+## 6. Version Control
+
+- Major revisions: Change whole number (1.0 → 2.0)
+- Minor revisions: Change decimal (1.0 → 1.1)
+- All revisions require re-approval
+- Revision history maintained in document footer
+
+## 7. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| Master Document List | Quality folder | Permanent |
+| Obsolete documents | Archive folder | 3 years after obsolescence |
+| Change requests | Quality records | 3 years |
+| Review records | Quality records | 3 years |
+
+## 8. Related Documents
+
+- FRM-001 Document Change Request
+- Master Document List
+- Document templates in `/Templates`
+
+## 9. References
+
+- ISO 9001:2015 Section 7.5 (Documented Information)
+- FDA 21 CFR Part 211.186 (Master Production and Control Records)
+- State Board of Pharmacy record-keeping requirements
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |