SOP FOR QUALITY ASSURANCE IN PHARMA

1. SOP for Allocation of Room Numbering and Equipment Numbering
2. SOP for SOP for Action Plan during failure of In-process Check
3. SOP for Album for Progress of Coating Process
4. SOP for Allocation of Room Number
5. SOP for Allotment of Batch Number
6. SOP for Change Control
7. SOP for Annual Review of Drug Product Quality (Annual Product Review)
8. SOP for Approval and Release of Batch (Finished Product)
9. SOP for Assigning of Manufacturing Date
10. SOP for Analytical Method Validation
11. SOP for Annual product quality review
12. SOP for AQL
13. SOP for Assigning of Identification number to equipment & Instruments
14. SOP for Assigning Retest Expiry period of Raw materials, Packing materials, Intermediates and Finished products
15. SOP for Batch Numbering System
16. SOP for Calibration Policy
17. SOP for CAPA corrective and preventive action handling procedure
18. SOP for Cleaning and Operation of Sampling thief
19. SOP for Cleaning Validation
20. SOP for Codification of Water user & Sampling point
21. SOP for Competency Level Evaluation of Quality Assurance and Quality Control Personnel
22. SOP for Conductivity Meter & TDS Meter
23. SOP for control of non conforming products
24. SOP for Core Tablet & Capsule Defect Album
25. SOP for Corrective Action and Preventive Action
26. SOP for Data Integrity
27. SOP for Date and Time Format
28. SOP for Department Organogram & Job Responsibility
29. SOP for Destruction of Materials
30. SOP for Destruction of Rejected RM, In-Process, FP & PM
31. SOP for Determination of Significant Figures and Rounding Rules
32. SOP for Development & Procurement of change parts (BPM)
33. SOP for Disinfectant Usage Policy
34. SOP for Disposition of Batch Returned material
35. SOP for Distribution and Dispatch of Batch
36. SOP for Document Control
37. SOP for Document Retention Period
38. SOP for Document Storage Period
39. SOP for Documentation & Data Control
40. SOP for Event & Investigation
41. SOP for Facility Qualification
42. SOP for final Inspection and Batch Release of Finished Products
43. SOP for Finished Product Control Sample Collection, Storage and Disposal
44. SOP for General safety guidelines
45. SOP for Glossary of terms
46. SOP for Guideline for the investigation in case of final product rejection
47. SOP for Handling Inspection by the International Regulatory Agencies
48. SOP for Handling of Cable tie
49. SOP for Handling of Confidential documents
50. SOP for Handling Of Customer Complaint
51. SOP for Handling of deviation
52. SOP for Handling of External Audits
53. SOP for Handling of Hold time Samples
54. SOP for Handling of Incident
55. SOP for Handling of Market Complaint
56. SOP for Handling of Non-Compliance
57. SOP for Handling of Non-Conformances
58. SOP for Handling of Out of Calibration (2)
59. SOP for Handling of Out of Calibration
60. SOP for Handling of Out of Specification Results 2
61. SOP for Handling of Out of Specification results
62. SOP for Handling of Out of Trend Results
63. SOP for handling of Regulatory communication
64. SOP for Handling of Regulatory Inspection
65. SOP for Handling of status labels
66. SOP for Hold time Study of Products
67. SOP for Impact Assessment of Process Variables on Product Quality
68. SOP for In Process checks
69. SOP for Inprocess control during manufacturing
70. SOP for Inprocess Control on the Packing Line
71. SOP for In-Process Sampling
72. SOP for IPQC During Packing
73. SOP for Issue and control of formats and registers books
74. SOP for Job responsibility of personnel in factory
75. SOP for Layout Numbering System
76. SOP for Line Clearance
77. SOP for List of List
78. SOP for Maintenance of Employees Specimen signatures
79. SOP for Market Complaint 01
80. SOP for Mock Recall Procedure
81. SOP for Monitoring of manufacturing activities
82. SOP for Monitoring recovery addition
83. SOP for MRP List
84. SOP for Numbering of validation, Qualification documents, equipments Instruments BMRBPR
85. SOP for Numbering system
86. SOP for Online Rejection
87. SOP for Operation and Preparation and Calibration for Walk in type Stability Chamber-compressed
88. SOP for Operation of Sampling device
89. SOP for Operation of Vacuum leak test apparatus
90. SOP for Operation, Cleaning, Calibration and Verification of Weighing Balance
91. SOP for Out of Specification
92. SOP for Performing of Equipment Validation & Qualification
93. SOP for Planned Modification System
94. SOP for Policy on Return Goods
95. SOP for Preparation of BMR & BPR
96. SOP for Preparation of Cleaning Validation and Hold time shelf life study Protocol & reports
97. SOP for Preparation of COA
98. SOP for Preparation of list of Authorized Personnel
99. SOP for Preparation of Master list
100. SOP for Preparation of Master Lists 1
101. SOP for Preparation of Master Updation form
102. SOP for Preparation of Validation & Qualification Protocol & Report
103. SOP for Preparation, Approval, Control, Issuance, Revision, Retrival and Destruction of STS, STP and GTP
104. SOP for Preparation, approval, distribution control, revision and destruction of Standard operating procedure
105. SOP for Preparation, revision, control and issuance of BMR BPR
106. SOP for Preventing of product and material mix-ups and cross contamination
107. SOP for Prevention of Contamination and Cross contamination
108. SOP for Procedure for Assignment of Expiry Date of Finished Product
109. SOP for Procedure for good documentation practice
110. SOP for Procedure for Handling of Deviation
111. SOP for Procedure for Handling of Market complaint
112. SOP for Procedure for Handling of Power Failure Situation
113. SOP for Procedure for Inactivation of Steroids
114. SOP for Procedure for Indent & Handling of Stereos
115. SOP for Procedure For Personnel Hygiene
116. SOP for Procedure for Recovery and Reprocessing
117. SOP for Procedure for Rectification and Correction of documents
118. SOP for Procedure for Sampling of Rinse Water swab
119. SOP for Procedure for Self Inspection
120. SOP for Process Standardization and Validation
121. SOP for Process Validation
122. SOP for Product Recall (2)
123. SOP for Product Recall 3
124. SOP for Protocol numbering system
125. SOP for Pure Steam Quality Test
126. SOP for Qualification of Contract Laboratory
127. SOP for Qualification of Equipment or Instrument
128. SOP for Qualification of Trainer and Auditor
129. SOP for Qualification Planner
130. SOP for Qualification Policy
131. SOP for Quality Council
132. SOP for Quality Management Review
133. SOP for Quality Risk Management
134. SOP for Recall Procedure for Dietary Supplements
135. SOP for Receipt Back Flush
136. SOP for Rejection Analysis
137. SOP for Restricted use (Password protected) of system
138. SOP for Retention and Disposal of Documents
139. SOP for Review, Approval and Control of Master Documents
140. SOP for Role & Responsibility of Quality Assurance Department
141. SOP for Root Cause Analysis
142. SOP for Rounding off and Reporting of results
143. SOP for Sampling of Intermediate & Finished Products
144. SOP for Sampling of Process Validation, Equipment Qualification, Cleaning Validation Hold Time Study Samples
145. SOP for Sampling procedure for withdrawal of stability samples
146. SOP for Scrap Management
147. SOP for Self Inspection
148. SOP for Servicing and Calibration of Balance
149. SOP for Site Master File
150. SOP for SOP
151. SOP for Specimen Signatures
152. SOP for Stability Management
153. SOP for Status label
154. SOP for Status Labeling
155. SOP for Swab Sampling During Product Changeover
156. SOP for Technical Agreement (2)
157. SOP for Technical Agreement
158. SOP for Technology Transfer
159. SOP for Terminal Inspection and Transfer of Finished Goods
160. SOP for Tolerance in the Calibration of Equipment Instruments Schedule
161. SOP for Training of Personnel in Factory
162. SOP for Training of Personnel
163. SOP for Trend preparation for QMS documents
164. SOP for Usage of Purified Water
165. SOP for Validation of Air Filtration system
166. SOP for Validation of Compressed air
167. SOP for Vendor Approval of Raw Materials
168. SOP for Vendor Management
169. SOP for Vendor Qualification
170. SOP for VMP
171. SOP for Yield deviation at different stages of processing
172. SOP of Procedure for Operation and Cleaning of Torque Tester
173. SOP of Lab QA
174. SOP of Procedure & Operation of Lux Meter
175. SOP for Destruction of Materials
176. SOP for Finished Product Control Sample Collection, Storage and Disposal
177. SOP for Job responsibility of personnel in factory
178. SOP for Root Cause Analysis
179. SOP for Handling of Pre-Market Supply Incidents
180. SOP for Action Items
181. SOP for Root Cause Analysis
182. SOP for methodology for carrying out Process Validation
183. SOP for Preparation & Review of Various Schedules
184. SOP for Packing Validation
185. SOP for Numbering System for Master Documents and Manufacturing Units
186. SOP for functions of QA observer
187. SOP for Sampling & Packline Inspection of Finished Products

SOP for Quality Assurance in Pharma

Purpose:
This SOP defines the Quality Assurance (QA) responsibilities and controls required to maintain GMP compliance, ensure consistent product quality, and protect patient safety throughout pharmaceutical manufacturing and testing.

Scope:
Applies to all QA activities across raw materials, production, packaging, laboratories, warehouses, utilities, and contract manufacturers (if applicable).

1) Roles and Responsibilities

• QA Head/Manager: Approves quality systems, ensures compliance, reviews trends and escalations.
• QA Officers/Executives: Perform routine QA oversight, documentation review, and investigations.
• Production/QC/Warehouse: Follow approved procedures and notify QA of deviations, incidents, and changes.

2) Document Control (GDP)

QA controls creation, review, approval, issuance, and archival of SOPs, BMR/BPR, logbooks, formats, and controlled copies. QA enforces Good Documentation Practices (GDP) including data integrity, corrections, and traceability.

3) Batch Release and Review

QA reviews Batch Manufacturing Records (BMR), QC results, deviations, and yield reconciliation. QA releases or rejects batches only after confirming compliance with approved specifications, validated processes, and regulatory requirements.

4) Deviation, Investigation, and CAPA

QA logs deviations, performs impact assessment, leads investigations (root cause tools like 5-Why/Fishbone), and approves CAPA. QA tracks CAPA effectiveness and closure timelines.

5) Change Control

QA evaluates and approves changes to materials, equipment, processes, utilities, facilities, suppliers, and documents. QA ensures risk assessment, validation/qualification needs, and regulatory impact are addressed.

6) Audits and Compliance

QA plans and conducts internal audits, vendor audits, and supports regulatory inspections. QA ensures timely response to findings and implements continuous improvement.

7) Training and Quality Culture

QA maintains training matrices, verifies competency, and promotes quality awareness across departments.

Records: BMR review checklist, deviation/CAPA forms, audit reports, change control records, training records.
References: GMP, GDP, site Quality Manual, validation master plan.