GMP

1. Three Consecutive Batches for Validation in Pharmaceuticals
2. NOEL and MACO Calculations in Cleaning Validation
3. Cleaning Validation of Clean-in-Place (CIP) Systems
4. Importance of Validation in Pharmaceuticals
5. How to Effectively Execute a Validation Protocol?
6. Revalidation of Equipment and Process in Pharmaceuticals
7. Alarm Challenge Test in Pharmaceuticals
8. Performance Qualification (PQ) of Pharmaceutical Equipment
9. Operational Qualification (OQ) in Pharmaceuticals
10. Validation of Fumigation in Cleanroom Area
11. Revalidation of Pharmaceutical Processes
12. Validation of the Effectiveness of UV Light in Water System
13. Detergents Used for Cleaning of Pharmaceutical Equipment
14. Regulatory Guidelines on Data Integrity
15. Identification of Worst Case in Cleaning Validation
16. Importance of Data Integrity in Pharmaceuticals
17. Procedure for Sampling in Process Validation
18. FDA New Data Integrity Guidelines:
19. Highlights Possible Causes of Out of Specification
20. Requirements of FDA for Training in Pharmaceuticals
21. Validation Program in Pharmaceutical Industries
22. Basics of Cleaning Validation
23. Validation of Utility Systems in Pharmaceutical
24. Facilities Basic Requirements for Process Validation Exercise
25. Requirements and Maintenance of HVAC System in Manufacturing Facilities
26. Epoxy Flooring and Its Benefits in Pharmaceuticals
27. Equipment Lubricants Used in Pharmaceuticals
28. ALCOA in Pharmaceuticals :
29. A necessary tool for Quality Gap Analysis for Regulatory Compliance
30. Sanitation of Cleanroom Area in Pharmaceutical
31. Manufacturing Planning and Procedure followed
32. During Regulatory Audits
33. Various Types of Blenders and Their Purpose
34. Lean Six Sigma Concept Difference Between HEPA and ULPA Filters
35. ALCOA Principles of Data Integrity Quality Inspection in Pharmaceuticals 30
36. Common Ways to Avoid the Most Frequent GMP Errors
37. Checks Before and After Installation of HVAC System
38. Top 5 Tips for a FDA Inspection
39. Criteria for Selection of Clean Room Garments in Pharmaceuticals
40. Factory Acceptance Test – FAT
41. Concept of GAMP 5 in Pharmaceuticals
42. Media Fill Test Failure Investigation
43. Reduce Validation Cost in Pharmaceuticals
44. Why Firms Must Avoid FDA 483 and Warning Letters?
45. What Does Quality Really Mean for Pharmaceuticals?
46. Quality System in Pharmaceuticals
47. Fault Tree Analysis for Investigation
48. Maintenance of Pharmaceutical Clean Area: FDA Recommendation
49. 5 Why Tool for Root Cause Analysis in Pharmaceuticals
50. ALCOA and ALCOA Plus Principles for Data Integrity
51. Organogram and Job Responsibilities in Pharmaceuticals
52. How Pharmaceutical Companies Can Prevent Drug Recalls
53. Data Integrity in Microbial Analysis
54. FDA Warning Letters for Cleaning Validation
55. Computerized System Validation Planning and Execution
56. 7 Steps for Monitoring Compliance in Pharmaceuticals
57. Difference between FDA 483 and Warning Letters
58. Trends in GMP Violations in Pharmaceuticals
59. Guidelines for Drug Master File Submission
60. Tips for a Successful FDA Inspection in Pharmaceuticals
61. Event Tree Analysis (ETA) in Pharmaceuticals Tablet
62. Defects in Pharmaceutical Manufacturing
63. The Stratified Sampling Approach in Process Validation
64. Contamination Control Strategies for Manufacturing Area
65. New Drug Application (NDA) Regulatory
66. Requirements and Guidelines for Cleaning Validation
67. Enhancing Efficiency and Quality: Implementing Lean Manufacturing Principles in Pharmaceutical Manufacturing
68. Data Integrity as per 21 CFR Rules
69. Implementation of Six Sigma in the Pharmaceutical Industry
70. How to Eliminate Microbial Contamination from Classified Area
71. Cleanrooms: Types, Origins, and Decontamination
72. Data Integrity – A Major Problem in Pharmaceuticals
73. Top 10 Tips for FDA Inspection Preparation
74. 5 Challenges Facing Pharmaceutical Warehousing
75. Determination of Data Integrity Compliance in Pharmaceuticals
76. 6 Ways to Reduce Human Errors in Pharmaceuticals
77. Key Preposes of Change Control in Pharmaceuticals
78. How to respond to an FDA 483 observations?
79. Different Types of Deviations in Pharmaceuticals
80. Different Ways to Improve Pharmaceutical Productivity and Product Quality
81. Procedure for Process Validation in Pharmaceuticals
82. Process Validation in Pharmaceutical Manufacturing
83. Difference Between Dynamic and Static Pass Box
84. Concept of GxP in Pharmaceuticals
85. Different Types of Stainless Steel for Pharmaceuticals
86. Hold Time Study in Pharmaceutical Manufacturing
87. Re-validation of Purified Water System
88. Planning and Execution of Internal Audits in Pharmaceuticals
89. Components of GMP : GMP in Detail
90. Importance of Data Integrity in cGMP:
91. Ensuring Drug Safety and Quality
92. New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols
93. Calculation for Capacity of Tablet Coating Machine
94. Root Cause Analysis with Examples GMP Violations
95. GMP Requirements in Pharmaceuticals
96. Out of Specification Investigation in Pharmaceuticals
97. Are You Ready for an FDA Inspection?
98. GMP and Room Design in Pharmaceuticals
99. The Impact of Training Management on Quality Issues
100. Tips for Effective Internal Audit System
101. How Gowning Practices Provide Clues to cGMP Compliance in Pharmaceuticals
102. Steps to Ensure CAPA Success in Pharmaceuticals
103. Purified Water System: Bio-contamination Control Techniques in Pharmaceuticals
104. Investigational New Drug (IND) Application
105. Pharmaceutical Compliance and Product Quality
106. What you should Inspect when Conducting Self-inspection in Pharmaceuticals
107. The Importance of Personal Protective Equipment in Pharmaceuticals
108. Good Distribution Practices for Pharmaceutical
109. Products Spillage Management in Pharmaceutical Production Area
110. Human Error: Some Fresh Approaches to Consider Allergen Control Plan for Pharmaceuticals
111. How to Conduct cGMP Training of Employees
112. Planning and Designing a Pharmaceutical Manufacturing Facility
113. FDA 483 Observations Related to Cleaning in Pharmaceuticals
114. Non-conformance in Pharmaceuticals and Ways to Prevent it
115. Improving Quality Through Supplier Audits in Pharmaceuticals
116. Essential Steps for Setting up a Pharmaceutical Cleanroom
117. The Rotation of Disinfectants Principle
118. In-Process Control Methods for the Active Pharmaceutical Ingredients Manufacturing
119. Building Better Manufacturing Facilities
120. How FDA Inspections are Conducted in Manufacturing Facilities
121. How to Improve Microbiological Control of Non-Sterile Pharmaceuticals
122. The Value of FDA 483s and Warning Letters
123. Data Integrity: How Important is it for Pharmaceutical Regulatory Bodies?
124. Sterile Pharmaceutical Manufacturing Area Cleaning
125. Data Falsification in Pharmaceutical Manufacturing: A Serious Crime
126. Safety Guards During Handling of Pharmaceutical Equipment
127. Requirements for Good Documentation Practice (GDP)
128. Data Integrity Survey Results
129. Why Cold Chain Logistics are Required in Pharmaceuticals?
130. Preparation of Batch Packaging Record (BPR)
131. Build a Quality Culture in Pharmaceuticals
132. Biosimilars and their Significance in Pharmaceuticals
133. Good Documentation Practices (GDP) in Pharmaceuticals
134. Principle and Working of Fluidized Bed Dryer (FBD)
135. Working and Principle of Tablet Coating Machine
136. Working and Principle of Colloidal Mill
137. Working and Principle of Rapid Mixer Granulator (RMG)
138. How to Start a Pharmaceutical Formulation Plant?
139. Is It Possible to Switch off HVAC System in Night?
140. Mode of Action of Disinfectant Solutions Cleaning and Housekeeping
141. Procedure in Pharmaceuticals Periodic Review and Compliance in the Pharmaceutical Industry
142. Self Inspection and Its Implementation in Pharmaceuticals
143. Fishbone Tool of Investigation in Pharmaceuticals
144. What does Inspector Look for during FDA Inspection?
145. FDA’s Top Data Integrity Issues Found During Inspections
146. How to Prepare for a FDA Inspection
147. 5 Most Common 483s in FDA Inspections
148. Why Data Integrity is More Important Than Ever?
149. Critical Mistakes during Root Cause Investigation
150. 4 Tips to Reduce 483 Observations
151. Preparation for GMP Audit in Pharmaceuticals
152. FDA Forms Generally Used in Pharmaceutical Inspection
153. FDA Form 483 and Warning Letters
154. Audit Trail Requirements in Pharmaceuticals
155. Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements
156. Current Good Manufacturing Practices – cGMP in Pharmaceutical Industries
157. Total Quality Management (TQM)
158. Importance of Qualified Persons in Pharmaceuticals
159. Code of Federal Regulations (CFR)
160. Requirements and Implementation of Continuous Training in Pharmaceuticals
161. Process Analytical Technology (PAT) in Pharmaceuticals
162. Quality by Design (QbD) in Pharmaceuticals
163. Checklist for Audit in Purchase Department GMP Audit
164. Check List- Storage of Starting Materials USFDA
165. Audit Points/ Observations Checklist for
166. Audit in Laundry GMP
167. Audit Check List- Personnel and Premises GMP Audit
168. Check List- Water Supply System GMP Audit
169. Check List- Weighing and Dispensing GMP
170. Audit Check List- Filling and Packaging GMP
171. Audit Check List- Process Validation GMP
172. Audit Check List- Sanitation and Hygiene GMP
173. Audit Check List- Equipment SOP for Corrective Action and Preventive Action (CAPA)
174. Isolators and Their Use in Sterile Manufacturing
175. Human Generated Contamination in Cleanroom and its Control
176. GLP in Microbiology Laboratory
177. Environmental Isolates and Their Library in Sterile Pharmaceuticals
178. Importance and Maintenance of Pressure Differential in Manufacturing Area
179. Requirement of Active and Passive Air Sampling in Controlled Areas
180. Different Types of Hand Disinfectants Used in Pharmaceuticals
181. Difference between Fumigation and Fogging
182. Environmental Risk from Microbial Waste
183. Computer System Validation in Pharmaceuticals
184. GMP for Sterile Pharmaceutical Manufacturing
185. Possibilities of Contamination in Sterile Products
186. Importance of Corrective and Preventive Action (CAPA)
187. Technology Transfer Guidelines for Pharmaceuticals
188. Best Weighing Practices in Pharmaceuticals
189. Requirement of Alarm System in Critical Equipments
190. Lux and Light Intensity for Pharmaceutical Areas
191. Importance of Blend Uniformity in Manufacturing Process
192. Handling Static Charge in Pharmaceutical Manufacturing
193. Airlocks and Change Rooms in cGMP Facility
194. Problems Associated with Pharmaceutical Cleanroom Areas Less than 1 CFU/Plate in ISO 5 Class – How is it Possible?
195. Role of Regulatory Affairs in Pharmaceuticals Abbreviated New Drug Application (ANDA)
196. Control of Contamination at Different Manufacturing Stages
197. Quality Manual and Quality Policy
198. Difference between Generic and Branded Medicines
199. Quality Metrics for Pharmaceutical Manufacturing
200. Difference between Recall and Mock Recall
201. Importance of Visual Inspection in Pharmaceutical Manufacturing
202. Difference between cGMP and GMP
203. Difference between GMP and GLP
204. Elemental Impurity Testing of Pharmaceutical Formulations
205. Different Types of Chemical Indicators for Sterilization
206. Drug Master File and Types of DMF
207. Bracketing and Matrixing in Pharmaceutical Stability
208. 21 CFR and Its Recommendations
209. Importance of Negative and Positive Controls in Microbial Analysis
210. Importance and Method of De-gassing in Purified Water System
211. Acceptable Quality Level (AQL) in Pharmaceuticals
212. Is Fungal Count Acceptable in Pharmaceutical Classified Area?
213. Role and Calculation of Air Changes per Hour in Clean Room
214. Area Depyrogenation in Injection Manufacturing
215. Containers for Pharmaceutical Packaging
216. Why Petri dishes Inverted During Incubation?
217. Principle of UV Spectrophotometer
218. Different Storage Conditions in Pharmaceuticals
219. Quality Risk Management in Pharmaceuticals
220. Importance of Mixing Time in Blend Uniformity
221. Incubation Conditions for Fungus and Bacteria
222. Using Common Media Preparation of Batch Manufacturing Record (BMR)
223. Risk of TSE and BSE in Pharmaceutical Products
224. Pharmaceutical Contamination Control
225. Microbial Resistance against Disinfectants Used for Cleaning
226. Protection of Light Sensitive Products
227. 3 Sigma Formula for Trend Analysis Limits
228. Shelf Life Estimation of Pharmaceutical Products
229. Sampling and Testing in Exhibit and Process Validation
230. Batches Layout for Injection Manufacturing
231. Unit Sampling Plan SQRT n+1 (√n+1) for Pharmaceuticals
232. Pass boxes in Classified Areas
233. Validation of Pure Steam Design of a Sterile Facility in Pharmaceuticals
234. Dead Leg and its Limit in Water Systems
235. Why 70% Isopropyl Alcohol (IPA) is used as Disinfectant in Pharmaceuticals?
236. Lyophilization of Parenteral Pharmaceutical
237. Products Difference between Incidence and Deviation
238. Principle of Hygrometer and Its Use in Pharmaceuticals
239. Different Types of Diffusers Used in Pharmaceutical Clean Rooms (Controlled Area)
240. Prevention of Cross- contamination in Pharmaceuticals
241. Prevention of Cross- contamination by HVAC in Pharmaceuticals
242. Corrective Action and Preventive Action (CAPA)
243. What does WHO say about cross-contamination?
244. WHO Qualification List for Pharmaceutical Equipments
245. Summary of ISO 14644 (ISO Cleanliness Classes)
246. Rounding off Figures of Analytical Results
247. Prevention of Cross – Contamination During Processing Mix Up and Cross Contamination in Pharmaceutical Manuacturing