Chapter 9 Good Manufacturing Practices

Appendix 9.1 GMP Inspection Worksheet

Establishment
Reg. No.
Inspector
Contact
Date

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

1.0 Food Safety Controls
Inspection TaskS/NS/NA/NRInspection TaskS/NS/NA/NR
1.1* Indicating thermometer reading ≥ minimum legal temperature and recorded on chart at a reference point.
DEIM 1.11.02.01&.1.11.02.02 (HTST); 1.12.01.01 &1.12.01.02 (Batch); 14.02.04 (APPS); 1.17.02.04 (HHST/ESL)		   1.2* Actual indicating thermometer reading ≥ recording thermometer temp. & recorded on present chart.
DEIM 1.11.02.02 (HTST); 1.12.01.02 (Batch)
1.14.02.04 (APPS); 1.17.02.04 (HHST/ESL)		  
1.3* Cut-in/cut-out verifications done properly at start up and recorded.
DEIM 1.11.02.02 & 1.11.11.03 (HTST);
1.14.11.01 (APPS); 1.17.11.01 (HHST/ESL)		   1.4* Seal intact on FCD, FDD, RTD, STLR, PDC, PLC
DEIM 1.11.06.02, 1.11.09.07, 11.11.07, 1.11.11.08, 1.11.12.04, (HTST);
1.14.06.02, 1.14.09.06, 1.14.10.05, 1.14.11.06, 1.14.11.07, 1.14.12.05 (APPS);
1.17.06.02, 1.17.09.06, 1.17.10.05, 1.17.11.06, 1.17.11.07, 1.17.12.05 (HHST/ESL)		  
1.5* No FCD bypass during hold. If the homogenizer is used as the FCD, there is no by-pass around the homogenizer during processing. A proximity switch is used so FDD will not operate in forward flow.
DEIM 1.11.06.03 (HTST);
1.14.06.03 (APPS); 1.17.06.03 (HHST/ESL)		   1.6* Batch pasteurization (including starter vats):
  • accurate hold time recorded
  • time & temp. ≥ minimum legal rqmts.
  • airspace thermometer ≥ 3°C than minimum legal temperature
DEIM 1.12.01.01, 1.12.01.02, 1.12.01.03, 1.12.02.04 (Batch) 		 
1.7* Batch pasteurization (including starter vats)
  • continuous agitation
  • inlet and outlet lines disconnected
  • lids closed
DEIM 1.12.02.01, 1.12.02.02, 1.12.02.03 (Batch)		   1.8* Other - Thermal Processing or no thermal processing
DEIM  1.13.02.02 - .04, 1.13.03.01 - .02, 1.13.07.01, 1.13.09.03, 1.13.10.01 - .02, 1.13.11.01 - .05, 1.13.12.01-04, 1.13.14.01 (Retort);
DEIM 1.13.18.01, 1.13.18.02, 1.13.18.03 (Coil Vat);
DEIM 1.13.19.01, 1.13.19.02, 1.13.19.03 (Formulation and Verification); - 60 day storage, records and labelling – production date for unpasteurized cheeses. DEIM 1.10.07.02 (E)		  
1.9 Frequency and temperature recording pens track the same time & all pens are functional.
DEIM 1.11.11.04 (HTST);
1.12.05.02 (Batch);
1.14.11.03 (APPS); 1.17.11.03 (HHST/ESL)		   1.10 STLR & MBTS Records/Charts completed with required information.
DEIM 1.11.02.02 (HTST);
1.12.01.02 (Batch);
1.14.02.04 (APPS); 1.17.02.04 (HHST/ESL)		  
1.11 Critical Process Test Procedures
  • frequency of testing
  • tests performed are in accordance with the Critical Process Test Procedures
  • records are kept
  • results reviewed in a timely manner by plant management
  • appropriate corrective action taken
DEIM 1.10.03.05;
Chapter 19, Appendix 19 - 6		   1.12 Microbiological and Composition Control and Records - review sampling of records for one product.
DEIM 1.10.07.03, 1.10.07.04
  • Slow vat records and calibration of pH meter for unpasteurized cheese
DEIM 1.10.03.01, 1.15.0.3204		  
1.13 Listeria Monitoring Program Records
  • review Listeria monitoring program records for highest risk product category (one prdt.)
  • assess frequency, sampling, methodology, follow up actions and notification.
DEIM 1.10.07.03		      

S = Satisfactory; NS = Not Satisfactory; NA = Not Applicable (indicate why); NE = Not Evaluated (indicate why)

2.0 Hygienic Practices
Inspection TaskS/NS/NA/NRInspection TaskS/NS/NA/NR
2.1 Sanitary handling of product, ingredients & packaging material
DEIM 1.10.02.03, 1.10.02.05, 1.10.02.06;
1.10.04.02 (C), 1.10.04.04;
1.10.07.02		   2.2 Well controlled movement of personnel & equipment between areas
DEIM 1.10.04.02 (B)		  
2.3 Absence of cross contamination
  • allergen and manufacturing controls DEIM 1.10.07.02
  • pests DEIM 1.10.01.04 (C), (D); 1.10.05.04
  • returned products DEIM 1.10.02.05 (D), (E)
  • garbage DEIM 1.10.01.05
  • structure DEIM 1.10.01.03, 1.10.01.04
  • non food chemicals DEIM 1.10.02.08
   2.4 Appropriate clothing, grooming and health condition of personnel. Usage of hand washing and sanitizing stations as required
DEIM 1.10.01.06 (A);
1.10.04.03 (A), (B)		  
  • FCD = Flow Control Device
  • FDD = Flow Diversion Device
  • RTD = Resistance Temperature Device
  • STLR = Safety Thermal Limit Recorder
  • PDC = Pressure Differential Controller
  • PLC = Programmable Logic Controller
  • MBTS = Metre Based Timing System
  • APPS = Aseptic Processing and Packaging System
  • HHST/ESL = Higher Heat Shorter Time Processing and Extended Shelf-Life Dairy Products

*Pasteurization and critical process tasks must be satisfactory. All product from non-satisfactory lots must be controlled through detention and/or product recall.

Observations/Comments:

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