Pharma Quality Desk - PQD

Dear Friends. In continuation to my previous blog on checklist for inspection readiness, I would like to share the checklist for failure investigation. Effective failure investigation program. Is there a written SOP covering failure investigation that has been approved by the Quality. SOP for investigation include a clear definition of events requiring and investigation that include:  Exceptional events,  Unexpected events,  Out of specification results,  Product or Process failure etc. Standard procedure covers the requirement that all investigation activities to be documented. SOP states that all investigation drive to a Root Cause or most likely Root Cause. Is root cause properly defined as the most likely primary cause for the event noted. Are investigation is initiated and completed as per the defined timeline. Containment procedure is part of SOP. List of specific requirements for the investigation. Provision for verifying the effectiveness of actions taken as ...

Introduction: Manufacture should ensure that the products they are manufacture are safe, effective and quality required for intended use. System should be in-place and in-use to ensure that the products manufactured as per validated process. As per Good manufacturing practices, manufacture should ensure that the dispensing raw materials and packing materials, intermediates products, bulk and finished product are stored under suitable conditions. Storage arrangement should be such which safeguard the subsequent processing, stability, safety, efficacy or quality of starting materials, intermediate products, and bulk drug prior to final packing. Maximum hold time should be established to ensure that intermediate and bulk product can be held without producing results outside the acceptance criteria for the quality of the material. Intermediate and bulk product should not be store beyond the established hold time. The choice of maximum hold time should be supported by relevant data. man...

Checklist are important to track or avoid any important points during routine work. Below are the some Important points which helps in GMP inspection readiness. Current Organograms Copies of new and existing regulatory submissions. Documents of recent regulatory agency inspection (reports and responses). Site master file. Facility floor plans. Site equipment list. SOP Index Training records. Master batch manufacturing records. Flow chart for the entire manufacturing and packing process. Example executed batch record. Equipment history records. Change Control SOP and summary of any relevant process change. Calibration SOP and Master calibration plan as well as summary of plan adherence along with calibration failure summaries. Preventative Maintenance program SOP and Master schedule. Summary of any manufacturing or specification change made as a result of API process change. Deviation control SOP and summary of all product rejection, process failure and manufacturing deviation, reworks ...

Background: As per schedule  M of "Drug and Cosmetic Act" self inspection is a tool to evaluate the manufacturer's compliance with GMP in all aspects of production and quality control. It is responsibility of manufacturer to consist a team of independent, experienced, qualified person from within or outside the company.  The procedure for self inspection shall be documented indicating self inspection results; evaluation, conclusion and recommended corrective action with effective  follow up  program. As per EU GMP requirement  (Chapter 9 Self Inspection) "Self inspection should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principle and to propose necessary corrective measures. Principle: The purpose of self-inspection is to evaluate the manufactures compliance with GMP in all aspect of production and QC. Self inspection should be performed routinely an may be, in addition, performed on special occasions, ex...