FDA – Page 293 – Pharma.Tips

Suppository Deformation during inspection readiness: CAPA with effectiveness checks for auditors

Addressing Suppository Deformation: A Comprehensive Investigation Guide for Inspection Readiness In the world of pharmaceutical manufacturing, one persistent challenge is the deformation of suppositories observed during inspection. This issue not…

Osmolality Oos during sterile filtration: sampling, filtration, and EM controls

Investigation of Osmolality OOS During Sterile Filtration: A Practical Approach The pharmaceutical industry often encounters out-of-specification (OOS) results, particularly concerning osmolality during sterile filtration processes for ophthalmic dosage forms. Such…

Viscosity Drift during bulk hold: GMP investigation and batch disposition

Investigating Viscosity Drift during Bulk Hold in GMP Compliance In the realm of pharmaceutical manufacturing, maintaining the integrity of product characteristics during bulk holds is paramount. A drift in viscosity…

Cooling Tunnel Variability after excipient change: manufacturing vs lab root cause decision tree

Investigation into Cooling Tunnel Variability Following Excipient Change Variability in cooling tunnel performance can significantly impact pharmaceutical manufacturing processes, particularly after an excipient change. This can lead to Out of…

Cleaning Validation Failure in suppository manufacturing: CAPA with effectiveness checks for auditors

Addressing Cleaning Validation Failures in Suppository Manufacturing: A Comprehensive Approach to CAPA Cleaning validation failures in suppository manufacturing can pose significant challenges to pharmaceutical companies, leading to potential deviations, out-of-specification…

Em Excursion during sterile filtration: packaging integrity and CCIT justification

Investigation of Em Excursion during Sterile Filtration: Ensuring Packaging Integrity and CCIT Justification In pharmaceutical manufacturing, especially in the production of ophthalmic dosage forms, maintaining the integrity of packaging during…

Cooling Tunnel Variability during bulk hold: GMP investigation and batch disposition

Investigation of Cooling Tunnel Variability during Bulk Hold in Pharmaceutical Manufacturing Variability in cooling tunnels can significantly impact the manufacturing process, especially during bulk holds of dosage forms such as…

Cleaning Validation Failure in suppository manufacturing: process controls for moulding, filling, and storage

Addressing Cleaning Validation Failures in Suppository Manufacturing for Enhanced Process Control In pharmaceutical manufacturing, particularly in the production of suppositories, maintaining rigorous cleaning validation processes is crucial. A cleaning validation…

Sterility Test Failure after packaging change: sampling, filtration, and EM controls

Sterility Testing Failures Following Changes in Packaging: A Comprehensive Investigation Framework A sterility test failure after a packaging change can pose significant risks in pharmaceutical manufacturing, particularly for sensitive products…

Microbial Limits Failure during cooling and moulding: packaging integrity and stability justification

Investigation of Microbial Limits Failure During Cooling and Moulding: Ensuring Packaging Integrity and Stability Correctly Justified In pharmaceutical manufacturing, particularly within the realm of rectal and vaginal dosage forms, microbial…

Fill Weight Variability in vaginal gel production: manufacturing vs lab root cause decision tree

Addressing Fill Weight Variability Issues in Vaginal Gel Production: An Investigation Framework In pharmaceutical manufacturing, fill weight variability can lead to significant quality concerns, especially in sensitive dosage forms like…

Packaging Leakage Complaint during cooling and moulding: process controls for moulding, filling, and storage

Addressing Packaging Leakage Complaints during Cooling and Moulding: A Comprehensive Investigation Framework In the pharmaceutical manufacturing landscape, packaging integrity is crucial to ensuring product quality and compliance with regulatory standards.…