PHARMA POLICIES

1. Policy on Training
2. Policy on Analytical Method Transfer
3. Policy on Quality Risk Assessment
4. Policy on Consultants
5. Policy on Vendor Management
6. Policy on Distribution
7. Policy on Annual Product Quality Review
8. Policy on Complaints
9. Policy on Validation of Computerized System
10. Policy on Working Standards
11. Policy on Quality Agreement Management
12. Policy on Status Labeling
13. Policy on Stability Study
14. Policy on Password
15. Policy on Backup & Restoration
16. Policy on Destruction of Rejected, Expired & Returned Material
17. Policy on Contamination Control
18. Policy on Method Validation & Method Verification
19. Policy on Blending of Batches (API)
20. Policy on Reworking (API & Intermediates)
21. Policy on Manual Integration
22. Policy on Calibration
23. Policy on Health & Hygiene
24. Policy on Recall
25. Policy on Change Management
26. Policy on Pharmacopoeia Implementation
27. Policy on Retention Samples
28. Policy on Site Master File
29. Policy on Policy Management
30. Policy on Batch Release-Rejection
31. Policy on Cleaning Validation
32. Policy on Risk Assessment for Selection of Environment Monitoring Locations
33. Policy on Internal Audit
34. Policy on Return Goods
35. Policy on Retention of Paper Document
36. Policy on Deviation Handling
37. Policy on Recovery of Solvents & Material (API)
38. Policy on Qualification
39. Policy on Data Logger
40. Policy on Cleaning & Sanitation
41. Policy on Product Transfer
42. Policy on Packaging Validation
43. Policy on Programmable Logic Controller (PLC) based systems
44. Policy on Pest Control
45. Policy on Process Validation
46. Policy on Environmental Control
47. Policy on Goods Laboratory Practices in Microbiology
48. Policy on Good Quality Control Laboratory Practices
49. Policy on Inspection Management
50. Policy on In-Process Control
51. Policy on Culture Maintenance & Identification
52. Policy on Inhouse Isolates
53. Policy on CAPA
54. Policy on Good Documentation Practices & Documentation
55. Policy on Investigation of Out of Specification Results
56. Policy on Extraneous Peak
57. Policy on Management Controls
58. Policy on Business Continuity
59. Policy on Escalation of Critical Non-Conformances
60. Policy on Area Classification & HVAC Design
61. Policy on Data Integrity

Why Pharma Policies Are Important

• Demonstrate management commitment to quality, safety, and compliance
• Provide a clear framework for writing SOPs, guidelines, and departmental procedures
• Align all departments (Production, QC, QA, Warehouse, Engineering, HR, IT) to the same principles
• Help during regulatory inspections by showing a structured, documented quality system
• Support training and culture building across the organization

Key Pharma Policies (Typical Set)

You can adapt or expand this list based on your company size and complexity.

1. Quality Policy
   • Commits to manufacturing safe, effective, and compliant products
   • Emphasizes GMP, continuous improvement, and customer/patient focus
   • Often displayed prominently in the facility and training rooms
2. GMP & Compliance Policy
   • States that all activities shall follow GMP, GDP, GLP and applicable regulations
   • Covers adherence to SOPs, validation, qualification, and regulatory approvals
3. Data Integrity Policy
   • Defines expectations for ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available)
   • Covers use of logbooks, electronic systems, audit trails, and handling of raw data
4. Documentation & Record Management Policy
   • Ensures controlled, traceable, and secure documents and records
   • Defines retention periods, archival, version control, and document approval
5. Deviations, CAPA & Change Control Policy
   • Outlines how deviations are reported and investigated
   • Defines CAPA expectations: root cause analysis, corrective and preventive actions
   • Sets principles for Change Control: risk assessment, impact evaluation, approvals
6. Validation & Qualification Policy
   • Commits to validating processes, cleaning, equipment, utilities, computerized systems
   • Links to Validation Master Plan (VMP) and lifecycle approach
7. Training & Competency Policy
   • Defines training requirements for all employees and contractors
   • Includes induction, GMP, role-specific training, and periodic re-training
8. Health, Safety & Environment (HSE) Policy
   • Focuses on employee safety, safe handling of chemicals, waste management, and environmental protection
   • Aligns with local legal requirements and best practices
9. Information Security & IT Policy (increasingly important)
   • Protects electronic data, systems, access controls, backups, cybersecurity
   • Covers use of electronic QMS, LIMS, ERP, and other GxP systems

Structure of a Good Pharma Policy

A clear policy document usually includes:

• Purpose & scope
• High-level principles and commitments
• Roles & responsibilities (Top management, QA, line managers, employees)
• Reference regulations & standards (GMP, WHO, ICH, national rules)
• Approval & review details (signatures, review frequency)