PHARMA POLICIES

Pharmaceutical policies in a manufacturing plant focus on ensuring product quality, safety, compliance, and efficiency. These policies are governed by regulatory agencies such as the FDA (U.S.), EMA (Europe), WHO, and CDSCO (India) and follow international guidelines like Good Manufacturing Practices (GMP).

Key Pharmaceutical Policies in Manufacturing Plants: Good Manufacturing Practices (GMP) Compliance / Quality Assurance (QA) & Quality Control (QC) / Data Integrity & Compliance / Environmental Health & Safety (EHS) Policies / Supply Chain & Raw Material Regulations / Automation & Technology Regulations / Product Recalls & Incident Management

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