IGMPI India

A new chapter no. 1790 which is regarding the 100% visual control of injectables is issued as a first draft in the Pharmacopeial Forum 41(1) for commenting. Pharmacopeial Forum is bimonthly online journal in which USP publishes proposed revisions to USP–NF for public review and comment. Main aim of Visual Inspection of Injections chapter is to control presence of particles in parenteral products along with giving indications to detect defects like cracks in primary containers or poorly fitting stoppers. The information provided in this chapter applies to the manual, the half-automatic and the fully-automated inspection of parenterals.

The new chapter is comprised of the following sub-chapters 1. Scope 2. Introduction 3. Typical Inspection Process Flow 4. Inspection Life-Cycle 5. Interpretation of Results 6. Inspection Methods and Technologies 7. Qualification and Validation of Inspection Processes 8. Conclusions and Recommendations 9. References

Sub Chapter 2 along with the introduction part also describes general statements regarding the patient risk due to presence of particulate matter with regards to the size and type of the particulate impurity and the patient's condition or age. Sub chapter 5 describes some practical tips to improve inspection results however, there are only very few tips for the fully-automated inspection.

Sub chapter 7 (Qualification/Validation of inspection processes) gives information mainly about the manual visual inspection. It comprises tips for the creation of test sets and the qualification as well as the re-qualification of personnel but there are no details referring to the qualification or re-qualification of fully-automated inspection processes.

The deadline for comments on the draft is 31 March 2015.