Sterile {Parenteral} formulations Interview Questions & Answers [2025] ||Pharmaceutical Concept | PC

Описание: Sterile {Parenteral} formulations Interview Questions & Answers.
This Video explains about Sterile {Parenteral} formulations Interview Questions & Answers Pharmaceutical concept || PC

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121. What are the key regulatory guidelines for sterile formulation development
122. What is the difference between cGMP and EU GMP for sterile formulations?
123. What is the significance of Annex 1 of EU GMP for sterile products?
124. How do you validate a sterile filtration process as per regulatory guidelines?
125. What is Quality by Design (QbD) and how is it applied in sterile formulations?
126. What are the regulatory requirements for Container Closure Integrity (CCI) Testing?
127. How do you demonstrate sterility assurance level (SAL) in sterile products?
128. What are the regulatory expectations for environmental monitoring in sterile manufacturing?
129. What regulatory tests are required for a sterile product stability study?
130. What are the regulatory requirements for visual inspection of sterile injectables?
131. What could cause precipitation in a sterile injectable formulation, and how would you resolve it?
132. What causes protein aggregation in biologics, and how do you prevent it?
133. How do you handle particulate contamination in sterile injectables?
134. What causes pH drift in injectable formulations, and how do you stabilize it?
135. How would you address stability failure in a lyophilized sterile product?
136. What could cause instability in an ophthalmic sterile solution?
137. How do you troubleshoot sterility failures in aseptic manufacturing?
138. What could cause vial breakage during sterile injectable filling?
139. What is the reason for color change in a sterile formulation?
140. How do you prevent glass delamination in sterile injectables?
141. How would you handle filter clogging during sterile filtration?
142. What causes cake collapse in lyophilized products, and how do you prevent it?
143. What causes high residual moisture in lyophilized cakes?
144. What causes shrinkage or cake pull-away in lyophilized vials?
145. What causes reconstitution failure (slow or incomplete dissolution)?
146. What could cause discoloration in a lyophilized cake?
147. What causes vial breakage during lyophilization?
148. What could cause batch-to-batch variability in lyophilized products?
149. What causes protein aggregation in lyophilized biologics?
150. How do you troubleshoot vacuum failure during lyophilization?

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