GMP Audit Checklist
Buildings and Facilities
Design and Construction
Yes
No
N/A
The facilities are properly taken care of, which includes the upkeep of roads, parking lots, grassy areas, and drainage systems.
1
2
3
Manufacturing facilities inside and outside are clean.
4
5
6
The area designated for equipment and materials is spacious enough to ensure that they can be placed in an organized manner, which helps to prevent confusion and the possibility of contamination.
7
8
9
There are environmental controls in place that are suitable for the situation, and they are consistently maintained.
10
11
12
The materials used for all surfaces that come into contact with food are suitable for their intended purpose.
13
14
15
Effective measures have been taken to prevent the undesirable reversal of water flow in all water systems.
16
17
18
Floors, walls, ceilings, doors and windows are completely sealed to prevent entry of pests.
19
20
21
There is separation of defined areas and adequate controls to prevent contamination.
22
23
24
Construction and Maintenance
Yes
No
N/A
Materials that are resistant to corrosion and non-toxic, such as stainless steel, are being utilized in the vicinity of the process.
25
26
27
Seams are well bonded and smooth.
28
29
30
Only lubricants and chemicals that are authorized for use in food-grade applications are being employed to operate the equipment.
31
32
33
A preventative maintenance program developed and implemented for major equipment.
34
35
36
Weighing, measuring, monitoring, and testing equipment critical for ensuring quality should be calibrated according to written procedures, established schedules and using certified or traceable standards.
37
38
39
Pest control program
Yes
No
N/A
There exists a program for controlling pests, and it has been properly documented.
40
41
42
Building exterior is protected from rodent and pest entry.
43
44
45
Map with locations of all traps identified.
46
47
48
Regular checks are carried out as part of the pest management plan.
49
50
51
The supplier maintains and enforces written procedures for the application of pesticides.
52
53
54
The facility conducts inspections to assess the performance of pest control operators.
55
56
57
Cleanliness and Sanitation
Yes
No
N/A
A detailed and written program is in place for cleaning and sanitizing the plant and equipment.
58
59
60
Maintaining the facility and equipment is essential for ensuring the safe production of healthy foods.
61
62
63
There are written operating procedures or work instructions.There are written operating procedures or work instructions.
64
65
66
Brushes and other utensils used for cleaning food contact surfaces are controlled and clearly identified.
67
68
69
Steps have been taken to confirm and track the efficiency of cleaning techniques.
70
71
72
Cleaning and sanitization procedures are validated and well-documented as such.
73
74
75
Cleaning and usage logs established for major equipment to include: dates, products, lots, person who used, person who cleaned.
76
77
78
A chemical control program manages the use, storage, and handling of non-food chemicals at the manufacturing facility.
79
80
81
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Materials and Management
General Controls
Yes
No
N/A
Written instructions should be available that outline the procedures for receiving, identifying, isolating, storing, managing, testing, and accepting or rejecting materials.
82
83
84
Appropriate environmental controls exist and are maintained.
85
86
87
Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
88
89
90
Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the quality unit(s)).
91
92
93
Cleanliness and Sanitation
Yes
No
N/A
A detailed and written program is in place for cleaning and sanitizing the plant and equipment.
94
95
96
Maintaining the facility and equipment is essential for ensuring the safe production of healthy foods.
97
98
99
There are written operating procedures or work instructions.There are written operating procedures or work instructions.
100
101
102
Brushes and other utensils used for cleaning food contact surfaces are controlled and clearly identified.
103
104
105
Steps have been taken to confirm and track the efficiency of cleaning techniques.
106
107
108
Cleaning and sanitization procedures are validated and well-documented as such.
109
110
111
Cleaning and usage logs established for major equipment to include: dates, products, lots, person who used, person who cleaned.
112
113
114
A chemical control program manages the use, storage, and handling of non-food chemicals at the manufacturing facility.
115
116
117
Storage
Yes
No
N/A
Temperature and humidly
118
119
120
Containers designed to protect against adulteration
121
122
123
Store and/or control rejected materials in segregated facility so as to prevent usage.
124
125
126
Warehouse area is clean and orderly – 18'' perimeter is maintained.
127
128
129
Materials should be re-evaluated, as appropriate, to determine their suitability for use
130
131
132
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Quality Control Systems
Process Quality Control Plan
Yes
No
N/A
A developed plan exists indicating inspection frequency, number of samples and required tests.
133
134
135
There are mechanisms established to guarantee that you possess and are adhering to the most up-to-date customer specifications.
136
137
138
Are product retains kept (finished, raw material, packaging) for a minimum of shelf life + 1 year?
139
140
141
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
142
143
144
Does QC have a product standard reference system?
145
146
147
Incoming Quality Control
Yes
No
N/A
There is a detailed plan that exists, which specifies how often inspections should be conducted, the quantity of samples needed, and the tests that are necessary.
148
149
150
Procedure exists for handling out of specification (OOS) results.
151
152
153
Does QC have updated product specifications?
154
155
156
Are customer product standards available and used?
157
158
159
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
160
161
162
Manufacturing
General Controls
Yes
No
N/A
Keep a record of the usage of all processing lines, major equipment, and containers during production.
163
164
165
Carry out filling, assembling, packing, and other tasks in a manner that prevents the contamination of products.
166
167
168
The techniques used to identify and oversee critical process control points must be documented in writing.
169
170
171
Manufacturing Process Control
Yes
No
N/A
Developed plan indicating inspection frequency, number of samples, required tests.
172
173
174
Procedure exists for Out-of-Specification results.
175
176
177
Are product standards routinely utilized?
178
179
180
Is production set up to meet Customer Specifications and Requirements?
181
182
183
Are there enough resources (qualified people, intermediate and final process checks, etc) to assure the production of a quality product?
184
185
186
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Quality Control Systems
General Controls
Yes
No
N/A
Establish and follow procedure for the receipt, storage, handling, sampling, examination & reconciliation of packaging materials.
187
188
189
Establish and follow procedure to ensure that correct labels, labeling and packaging materials are issued and use.
190
191
192
Label Issuance and Control
Yes
No
N/A
Restricted access to the label storage zones should be granted solely to personnel who are authorized.
193
194
195
Procedures should be established for the destruction of obsolete and out-dated labels.
196
197
198
Procedures should be established to reconcile the quantities of labels issued, used, and returned.
199
200
201
Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record.
202
203
204
The batch production record should contain a printed label that represents the labels used during production.
205
206
207
Packaging and Labeling Operations
Yes
No
N/A
Provide adequate separation between different packaging / labeling operations being carried out simultaneously in the same area.
208
209
210
Label packages and ingredients with a lot number that enables tracing of their history and facilitates batch management.
211
212
213
Inspect packaged and labeled goods to verify that the lot number and label information are accurate.
214
215
216
Ensure that proper line clearance procedures are in place and utilized during changeovers.
217
218
219
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Personnel and Training
Qualifications and Experience
Yes
No
N/A
An organizational chart exists which reflects the most current reporting structure.
220
221
222
Job descriptions throughout the organization include responsibilities for supporting quality objectives.
223
224
225
An adequate number of qualified personnel exist to perform functions in manufacturing, packaging and QA.
226
227
228
Training Procedures
Yes
No
N/A
Have procedures been established and used for identifying training needs? Training procedure(s) shall exist for all levels including part-time and temporary staff, management, visitors, contract/construction personnel, consultants, government and customer auditors.
229
230
231
Procedures address training schedules such as upon hire, future training requirements, follow up and/or retraining frequencies.
232
233
234
Training effectiveness is evaluated on a periodic basis.
235
236
237
Are qualifications and training records maintained for all personnel?
238
239
240
Specific training requirements are defined for each unique job description or job function.
241
242
243
Purchasing and Customer Service
Purchasing
Yes
No
N/A
Is there a system to notify customers of delivery days?
244
245
246
How are they notified? E-mail, fax, phone, mail? Is this documented?
247
248
249
What systems or processes are in place for Cost of Quality (i.e. scrap, reduction, rework, commodity planning)?
250
251
252
An up-to-date organization chart with names/key personnel available.
253
254
255
Customer Service
Yes
No
N/A
Is there evidence of a Customer Service System?
256
257
258
Is there a process for requesting samples or information?
259
260
261
Is there any contact list?
262
263
264
Date
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Month
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Day
Year
Date
Email
example@example.com
Signature
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