Calibration records of instruments, where applicableĬheck the Batch Manufacturing Record of the product under investigation Line Clearance record (cross check with the Batch Manufacturing Record of the previous product mentioned) blender, sifter, filling machine and check the following:
Observe the area environment conditions and cross check with the records. Storage conditions of materials during the period dispensed material was stored prior to the start of batch manufacturing Batch manufacturing started on : (date) (time) Has the checking of area undertaken by IPQA as per frequency mentioned in the SOPĬheck and record the following information w.r.t. Has rotation of disinfectants implemented
During the period of manufacture of the productĪre the SOPs relevant to operations accessible and available for use?Īre the equipment labelled according to their status and content? Verify Standard Operating Procedures relevant to different manufacturing operations. Is the access to the printed packaging material store restricted?ĭoes Store maintain list of persons authorised to entry areas with “restricted entry”?Ĭhecking of Manufacturing Operation and records Master weight certificate (Issuance date: valid up to: ) Stored as per recommended Storage conditions Stored properly (isolated from floor and detached from the walls) During period of manufacture of product under investigationĪre the materials available in Stores (both Raw Material and Packaging Material Store) Material receipt, Dispensing and storage of materials, handling of etc. Verify Standard Operating Procedures for accuracy of procedure, records maintained and operational status of the SOPs e.g.
Adherence to the Standard Operating Procedures for storage and withdrawal of control samples in its specification?Ĭheck the raw material reserve / control samples in Quality Control for : Check the environmental conditions in the quarantine area during storage of material(s)ĭoes the Raw Materials Specification of the raw materials, especially the API include parameters like particle size, density, etc. – If the vendor is approved, has the vendor appraisal been conducted – Transportation chosen (measures taken by the transporters to prevent exposure of material to heat, humidity, light, etc.)
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