Here’s a detailed, plagiarism-free, UK-compliant article written in an attractive, structured bullet-point format, suitable for pharma professionals, QA documentation, blogs, or training material.
Comprehensive SOP List for Pharmaceutical Operations
(UK GMP & MHRA Compliant)
Standard Operating Procedures (SOPs) form the backbone of compliance, quality assurance, and operational excellence in the UK pharmaceutical industry. Aligned with UK GMP, MHRA expectations, and ICH guidelines, SOPs ensure consistency, data integrity, and patient safety across all functions.
📌 SOP List for Quality Assurance (QA) – UK GMP Compliant
QA SOPs ensure overall compliance with UK GMP and MHRA regulations.
- Quality Management System (QMS) overview
- Document control and document lifecycle management
- SOP creation, review, approval, and archival
- Deviation management and investigation
- CAPA initiation, implementation, and effectiveness check
- Change control management
- Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) review
- Product Quality Review (PQR) / Annual Product Review (APR)
- Internal audits and self-inspection
- Data integrity (ALCOA+) compliance
- Risk management (ICH Q9)
- Training management system
- Supplier and vendor qualification oversight
- Regulatory inspection readiness and management
📌 SOP List for Quality Control (QC) – UK Compliant
QC SOPs focus on laboratory controls and analytical compliance.
- Sample receipt, labeling, storage, and disposal
- Analytical method validation and verification
- Instrument calibration and maintenance
- Handling of reference standards and working standards
- OOS (Out of Specification) and OOT (Out of Trend) investigations
- Laboratory data integrity and audit trail review
- Stability testing and trend analysis
- Environmental monitoring coordination
- Retention sample management
- Laboratory safety and waste disposal
- Handling of atypical and invalid results
📌 SOP List for Production – UK GMP
Production SOPs ensure controlled manufacturing operations.
- Manufacturing process flow and controls
- Line clearance and area clearance
- Equipment operation and cleaning
- In-process controls (IPC)
- Batch documentation and real-time recording
- Handling of deviations during production
- Yield reconciliation
- Cross-contamination prevention
- Personnel hygiene and gowning
- Cleaning validation support
- Hold-time management
📌 SOP List for Warehouse – UK Pharmaceutical Operations
Warehouse SOPs maintain material integrity and traceability.
- Goods receipt and quarantine management
- Approved and rejected material segregation
- Temperature and humidity monitoring
- FEFO/FIFO material issuance
- Controlled drug and hazardous material storage
- Labeling and status control
- Stock reconciliation and inventory control
- Dispatch and transportation documentation
- Handling of returned goods
- Cold chain management
📌 SOP List for Microbiology Laboratory – UK GMP
Microbiology SOPs ensure sterility and contamination control.
- Environmental monitoring (cleanrooms & controlled areas)
- Sterility testing procedures
- Microbial limit testing
- Media preparation and media growth promotion testing
- Handling and disposal of biohazardous waste
- Aseptic technique and gowning qualification
- Trend analysis and contamination investigation
- Cleaning and disinfection validation
- Microbial identification and preservation
📌 SOP List for Validation Department
Validation SOPs confirm processes, systems, and equipment suitability.
- Validation Master Plan (VMP)
- Equipment qualification (DQ, IQ, OQ, PQ)
- Process validation (prospective, concurrent, retrospective)
- Cleaning validation
- Analytical method validation support
- Computer System Validation (CSV)
- Utilities qualification (HVAC, water systems)
- Revalidation and periodic review
- Change control impact assessment
📌 SOP List for Regulatory Affairs – UK
Regulatory SOPs ensure compliance with MHRA and global requirements.
- Regulatory submission management
- Variation classification and filing (UK-specific)
- Dossier preparation (CTD format)
- Regulatory intelligence and updates
- Labeling and artwork control
- Post-approval change management
- Regulatory commitments tracking
- Communication with MHRA
- Archival of regulatory documents
🔹 Individual SOP Topics (Detailed Focus Areas)
✅ SOP for Deviation Management (UK GMP)
- Identification, classification, and documentation of deviations
- Root cause analysis (RCA) tools
- Impact assessment on product quality
- Timelines for investigation and closure
- QA approval and trending
✅ SOP for CAPA (MHRA Compliant)
- CAPA initiation from deviations, audits, or complaints
- Risk-based CAPA prioritization
- Action plan development and ownership
- Effectiveness checks and closure
- CAPA trending and management review
✅ SOP for Change Control
- Change request initiation and classification
- Risk and impact assessment
- Regulatory impact evaluation
- Implementation and verification
- Change closure and documentation
✅ SOP for OOS and OOT
- Phase I and Phase II investigations
- Laboratory and manufacturing review
- Hypothesis testing and justification
- QA approval for retesting or resampling
- Trend analysis and preventive actions
✅ SOP for Batch Record Review
- Review of manufacturing and packaging records
- Verification of critical process steps
- Documentation error handling
- Yield reconciliation review
- Final QA disposition
✅ SOP for Line Clearance
- Pre- and post-operation clearance checks
- Prevention of mix-ups and cross-contamination
- Line clearance checklist documentation
- QA verification and approval
✅ SOP for Stability Studies (ICH Q1)
- Stability protocol preparation
- Sample storage and pull schedules
- Testing intervals and parameters
- Trend analysis and shelf-life assignment
- Stability failure investigation
✅ SOP for Vendor Qualification (UK)
- Vendor selection and risk assessment
- Initial and periodic audits
- Quality agreements
- Performance monitoring
- Vendor requalification
✅ SOP for Training Management
- Training needs identification
- SOP-based training programs
- Effectiveness evaluation
- Training matrix maintenance
- Retraining and change-related training
🔍 Conclusion
A well-structured SOP system aligned with UK GMP, MHRA, and ICH guidelines is essential for regulatory compliance, audit readiness, and product quality assurance. Implementing department-specific and topic-focused SOPs strengthens operational control and ensures consistent pharmaceutical manufacturing practices across the UK industry.
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