TRIGGERING OF INSPECTIONS There are two types of events that trigger inspection: categories that will regularly prompt an inspection request, and categories in which the district office may elect to perform an inspection at their discretion for elements of applications — filed or otherwise. The following categories will regularly prompt a pre-approval or cGMP: 1. … Read more

Electronic Signatures

Electronic Signatures Controls for identification codes/password Persons who use electronic signatures based upon the use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination … Read more

Maintenance of microbiological control and quality: In stability

Maintenance of microbiological control and quality: In stability Container-Closure Integrity The ability of the container-closure system to maintain the integrity of its microbial barrier hence, the sterility of a drug product throughout its shelf life, should be demonstrated. Sterility testing at the initial time point is not considered sufficient to demonstrate the microbial integrity of … Read more

Un-Planned Deviation & Incident Example – II

Un-Planned Deviation Example Investigation Details for Incident No.:____________________________________ 1.0       Product details Name of product B. No. B. Size Batch stage Granulation (Lubrication) Investigation team member details Production Supervisor IPQA Production Manager QC Head Warehouse In Charge QA Head Incident details Lubricated granules of the batch containing API (Clobazam) and excipients (MCCP PH 102, Cross … Read more

Un-Planned Deviation Example – I

  Un-Planned Deviation Deviation Investigation Report Description of Deviation: The document entry of dispensing and cleaning records is not recorded by the respective operators. Type of deviation:  Un-Planned Deviation Class of Deviation:  Minor Date of investigation:   Department:  Warehouse Date of deviation Observed:   Investigations start date:   Investigation completion date:  INVESTIGATION TEAM S.No. Name Designation Department 1. … Read more