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