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Document that is no longer current and has been superseded |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
- Document owner identifies need for new document
- Selects appropriate template from
/Templates
- Drafts document following standard format
- Ensures pediatric-specific considerations are included
- Assigns unique document ID according to numbering convention
- Routes for technical review
5.2 Document Review
- Subject matter experts review for technical accuracy
- Quality Manager reviews for compliance with standards
- Clinical pharmacist reviews for pediatric appropriateness
- Reviewers provide feedback within 5 business days
- Document owner incorporates feedback
5.3 Document Approval
- Document owner submits final version for approval
- Approver reviews complete document
- Approver signs/dates document or provides approval comment
- Quality Manager assigns effective date (minimum 7 days from approval)
- Document added to Master Document List
5.4 Document Distribution
- Quality Manager publishes approved document to repository
- Notification sent to all affected personnel
- Training conducted if required
- Old version moved to archive (if revision)
5.5 Document Revision
- Anyone may initiate revision request via change request form
- Document owner evaluates need for revision
- If approved, follows creation process with new revision number
- Revision history table updated with change description
- All copies of previous version removed from use
5.6 Periodic Review
- All documents reviewed at least annually
- Review verifies:
- Content remains accurate and current
- Regulatory references are up to date
- Pediatric practice standards are current
- Process remains effective
- Review documented even if no changes made
- 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] |
