GMP Audit checklist for Weighing and Dispensing

Weighing and Dispensing

• Are proper measures taken regarding lighting, ventilation and air control facilities for dispensing areas?
• Are the procedures released by Quality control?
• Are the standard operating procedures followed while weighing?
• Is there a specified arrangement for dispensing of starting materials?
• Is proper control on entry of men and material into dispensing area?
• Is reverse LAF provided for dispensing with supply of clean air from background?
• Is the pressure difference maintained between dispensing area and adjacent area?
• Do the written procedures identify the steps in the weighing of material for production?
• Do procedures exist for documentation of correct measure or weight?
• Is the weighing and measuring of raw materials supervised by a person?
• Are there written procedures for identification of containers?
• Are the containers with the materials properly identified?
• Is the material released by the Quality control?
• Does the amount for dispensing agree with the batch record?
• Is there a second person weighing and verifying accurately with a second signature?
• Are the weighing operations performed by a qualified person and observed by a second person?
• Do the records indicate the preceding policy followed by two signatures?
• Are the yields calculated at appropriate phases of operation and at the end process?
• Are the calculations done by a single person and an independent verification by a second person?
• Are the values of actual yield and percentages of theoretical yield determined at end of every phase?
• Is a document regarding the yield values and percentages?
• How are the dispensing tools cleaned, maintained and dried?
• Are proper steps taken for spillage, leakage and breakage of containers?
• Are there any provisions to prevent rodents, birds and insects?
• Is the pest control programme followed as per the SOP?

Weighing, dispensing, records, calculations, gmp audit checklist

mcrhrdi.gov.in

fda.gov

cdsco.nic.in