Gmp Good Manufacturing Practice Audit Construction

​

Use this checklist

Download as PDF

GMP (Good Manufacturing Practice) Audit - Construction



Design And Construction

1. Facility grounds are well maintained including roads, parking lots, grass and drain areas.


Photo Comment

2. There is adequate space provided for orderly placement of equipment and materials to prevent mix-ups and contamination.


Photo Comment

3. Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity, lighting, etc...).


Photo Comment

4. All food contact surfaces are made of materials appropriate to the application (i.e. stainless steel vs. aluminium).


Photo Comment

5. All water systems are adequately protected against back flow.


Photo Comment

6. There are adequate hand-washing facilities for rest rooms, break areas and manufacturing areas.


Photo Comment

7. Floors, walls, ceilings, doors and windows are completely sealed to prevent entry of pests.


Photo Comment

8. Loading dock doors are flush to the floor when closed.


Photo Comment

9. There is separation of defined areas and adequate controls to prevent contamination.


Photo Comment
Construction And Maintenance

1. Non-toxic and corrosion-resistant materials such as stainless steel are being used around the process.


Photo Comment

2. Seams are well bonded and smooth.


Photo Comment

3. Lubricants and chemicals used for operation of equipment are approved for food grade applications.


Photo Comment

4. A preventative maintenance program developed and implemented for major equipment.


Photo Comment

5. 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.


Photo Comment
Pest Control Program

1. A documented pest control program is in place.


Photo Comment

2. Building exterior is protected from rodent and pest entry.


Photo Comment

3. Map with locations of all traps identified


Photo Comment

4. The pest control program includes frequent inspections.


Photo Comment

5. The supplier maintains and enforces written procedures for the application of pesticides.


Photo Comment

6. All chemicals used in pest control are accurately labelled and stored securely


Photo Comment

7. The facility audits pest control operator performance.


Photo Comment
Cleaning & Sanitation

1. There is a written and comprehensive plant and equipment sanitation program.


Photo Comment

2. Facility and equipment maintenance ensure safe manufacture of wholesome foods.


Photo Comment

3. There are written operating procedures or work instructions.


Photo Comment

4. Brushes and other utensils used for cleaning food contact surfaces are controlled and clearly identified.


Photo Comment

5. Measures are in place to verify and monitor the effectiveness of cleaning methods.


Photo Comment

6. Cleaning and sanitization procedures are validated and well-documented as such.


Photo Comment

7. Cleaning and usage logs established for major equipment to include dates, products, lots#, person who used, person who cleaned.


Photo Comment

8. Hoppers, tanks and similar food receptacles must be properly covered.


Photo Comment

9. A chemical control program manages the use, storage, and handling of non-food chemicals at the manufacturing facility.


Photo Comment
Materials Management

1. There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejections of materials.


Photo Comment

2. There should be a system for control of GMO/non-GMO allergens.


Photo Comment

3. Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity, lighting, etc...).


Photo Comment

4. Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.


Photo Comment

5. Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the quality unit(s)).


Photo Comment
Traceability

1. Lot trace system with distinctive lot number for all raw materials, in-process materials, finished goods, and packaging components.


Photo Comment

2. Establish and document First-in/First out(FIFO) procedures for all materials and goods.


Photo Comment
Storage

1. Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.


Photo Comment
Temperature And Humidly

1. Containers designed to protect against adulteration.


Photo Comment

2. Store and/or control rejected materials in segregated facility to prevent usage.


Photo Comment

3. Warehouse area is clean and orderly - 18"" perimeter is maintained.


Photo Comment

4. Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after prolonged storage or exposure to heat or humidity).


Photo Comment
Process Quality Control Plan (Packaging / Raw Materials)

1. A developed plan exists indicating inspection frequency, # of samples & required tests.


Photo Comment

2. Procedure for OOS results, how is this info related to production, what is done with product.


Photo Comment

3. Systems are in place to ensure that you have and are following the most current customer specification.


Photo Comment

4. Does QC have a product standard reference system?


Photo Comment

5. Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?


Photo Comment

6. Is product retains kept (finished, raw material, packaging) for a minimum of shelf life + 1 year?


Photo Comment
Incoming Quality Control

1. A developed plan exists indicating inspection frequency, # of samples & required tests.


Photo Comment

2. Procedure exists for handling out of specification (OOS) results.


Photo Comment

3. Does QC have updated product specifications?


Photo Comment

4. Are customer product standards available and used?


Photo Comment

5. Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?


Photo Comment
QC Micro Lab

1. A developed plan exists indicating inspection frequency, # of samples & required tests


Photo Comment

2. Procedure exists for handling out of specification (OOS) results.


Photo Comment

3. Does Micro QC have updated product specifications?


Photo Comment

4. Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?


Photo Comment

5. Is there a documented, effective lab cleaning & sanitization program including environmental monitoring?


Photo Comment

6. Does a documented calibration and maintenance program exist?


Photo Comment

7. Does a validation program exist?


Photo Comment
QC Analytical Lab

1. A developed plan exists indicating inspection frequency, # of samples & required tests


Photo Comment

2. Procedure exists for handling out of specification (OOS) results.


Photo Comment

3. Does Analytical QC have updated product specifications?


Photo Comment

4. Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?


Photo Comment

5. Does a documented calibration and maintenance program exist?


Photo Comment

6. Does a validation program exist?


Photo Comment

7. Does a process exist for maintenance of lab standards?


Photo Comment

8. Does a process exist for the control & documentation of lab reagents?


Photo Comment

9. Establish, validate and document test methods.


Photo Comment
Batch Records

1. Shall contain list of raw materials, names, characteristics, identification, lot #(s), weights.


Photo Comment

2. Shall include total and theoretical weights/measures, min/max percentage. (Values outside acceptable ranges require investigation).


Photo Comment

3. Shall include detailed manufacturing instructions & process control set points to assure purity, quality & consistent composition.


Photo Comment

4. Shall include documentation of each significant step in the manufacturing process.


Photo Comment

5. Shall contain special notes of investigation/deviation from the prescribed process.


Photo Comment

6. Shall be reviewed and approved by Quality Assurance (QA) for each individual batch run.


Photo Comment

7. Shall be retained for at least 1 year after the expiry date of the batch.


Photo Comment
Contamination

1. Any material observed to have insect infestation shall be quarantined and immediately removed from premises.


Photo Comment

2. Effective measures shall be taken to protect against metal and extraneous materials.


Photo Comment
General Controls

1. Identify and record usage of all containers, processing lines & major equipment during production.


Photo Comment

2. Perform filling, assembling, packing, and other operations in such a way that products are not adulterated.


Photo Comment

3. Methods for establishing & monitoring critical process control points should be stated in writing.


Photo Comment
Manufacturing Process Controls

1. Developed plan indicating inspection frequency, # of samples, required tests


Photo Comment

2. Procedure exists for Out-of-Specification results. What is done with product?


Photo Comment

3. Are product standards routinely utilized?


Photo Comment

4. Is production set up to meet Customer Specifications and Requirements?


Photo Comment

5. Are there enough resources (qualified people, intermediate and final process checks, etc) to assure the production of a quality product?


Photo Comment
Packaging And Identification Labelling

1. Establish and follow procedure for the receipt, storage, handling, sampling, examination & reconciliation of packaging materials.


Photo Comment

2. Establish and follow procedure to ensure that correct labels, labelling and packaging materials are issued and use.


Photo Comment
Label Issuance And Control

1. Access to the label storage areas should be limited to authorized personnel.


Photo Comment

2. Procedures should be established to reconcile the quantities of labels issued, used, and returned.


Photo Comment

3. Procedures should be established on how to investigate / evaluate any discrepancies found between number of containers labelled and number of labels issued.


Photo Comment

4. Procedures should be established for the destruction of obsolete and out-dated labels.


Photo Comment

5. Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications in the master production record.


Photo Comment

6. A printed label representative of those used should be included in the batch production record.


Photo Comment
Packaging And Labelling Operations

1. Provide adequate separation between different packaging / labelling operations being carried out simultaneously in the same area.


Photo Comment

2. Identify packages and ingredients with a lot number that permits determination of history and control of batch.


Photo Comment

3. Examine packaged and labelled products to ensure that they have the correct label and lot #.


Photo Comment

4. Ensure that proper line clearance procedures are in place and utilized during changeovers.


Photo Comment
Quality Management Systems

1. An organizational chart exists which reflects the current reporting structure & responsibilities.


Photo Comment

2. Does the organization have an established and maintained quality management unit?


Photo Comment

3. There is a management representative with defined authority and responsibility for meeting customer compliance.


Photo Comment

4. Qualified technical personnel are available for design, process, product, and service support.


Photo Comment

5. A quality manual has been developed which details the quality system of policies and procedures.


Photo Comment

6. Quality manual procedures identify • Who is responsible for action? • What has to be done? • When are actions required?


Photo Comment

7. The responsibility for updating and revising the quality manual and system is well defined.


Photo Comment

8. Company quality objectives are documented, signed and dated.


Photo Comment

9. Quality objectives are communicated, understood, and maintained throughout the organization.


Photo Comment

10. Written procedures address the following types of planning: • Establishment of requirements • Verification of requirements • Acceptance procedures • Quality information systems • Customer satisfaction • Change control


Photo Comment

11. Ongoing quality improvements are a part of the plant manager’s objectives.


Photo Comment

12. Quality costs are used for evaluating and planning.


Photo Comment

13. Documented evidence exists that advanced quality planning activities are reviewed with customers.


Photo Comment
Effectiveness Of The Quality Management Systems

1. Lead times are measured and tracked


Photo Comment

2. The total cost of quality is tracked


Photo Comment

3. Cycle times measured and tracked


Photo Comment

4. Annual Quality improvement goals are set by top management


Photo Comment

5. Goals are regularly reviewed by top management.


Photo Comment

6. There is a system in place to verify that objectives are met and quality policy is adhered to.


Photo Comment

7. Achievement of quality objectives is a high priority in overall performance reviews.


Photo Comment

8. The quality manual is regularly reviewed, revised, and communicated throughout the organization.


Photo Comment

9. There is a documented and objective process in place to measure and track customer satisfaction.


Photo Comment
Internal Audits

1. There is a documented procedure for conducting internal quality audits.


Photo Comment

2. Internal audits are conducted semi-annually or scheduled based on status and importance of activity.


Photo Comment

3. Audit includes work environment and general housekeeping.


Photo Comment

4. Internal audit results are documented and brought to attention of management.


Photo Comment

5. There is an established and documented complaint investigation and response program.


Photo Comment

6. Establish and document rework and reprocessing procedure


Photo Comment

7. Corrective actions are timely, recorded, and evaluated for effectiveness.


Photo Comment
Personnel And Training

1. An organizational chart exists which reflects the most current reporting structure.


Photo Comment

2. Job descriptions throughout the organization include responsibilities for supporting quality objectives.


Photo Comment

3. An adequate number of qualified personnel exist to perform functions in manufacturing, packaging and QA.


Photo Comment
Hygienic Practices

1. Are there hygienic practices in place to protect against contamination of food?


Photo Comment

2. Personnel should wear clean clothing suitable for the manufacturing activity. Additional protective apparel, such as head, face, hand, and arm coverings should be worn, when necessary.


Photo Comment

3. Any person, by medical examination or supervisory observation, that is shown to have, or appears to have, an illness, or open lesions, by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials being contaminated, shall be excluded from any operations until condition is corrected.


Photo Comment

4. Personnel shall be instructed to report such conditions to supervisors.


Photo Comment

5. Designated areas outside of processing zones have been provided for clothing and other personal belongings (Jackets, cell phones, bags, radios, CD players, headsets, pagers).


Photo Comment

6. Consumption of food & beverages, chewing of gum, or the use of tobacco products are strictly prohibited in processing areas.


Photo Comment

7. Proper hand washing practices are reinforced with signs posted in breakrooms, production areas, and washrooms.


Photo Comment

8. Written procedures exist which address and include the control and proper supervision of the above practices.


Photo Comment
Training Procedures

1. 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.


Photo Comment

2. Procedures address training schedules such as upon hire, future training requirements, follow up and/or retraining frequencies.


Photo Comment

3. Training effectiveness is evaluated on a periodic basis.


Photo Comment

4. Employee training covers general topics such as cGMP, sanitation, safety, environment, SOPs & MSDS. In addition, training is provided on specific work instructions, procedures, equipment operations, or as required to perform a specific job function.


Photo Comment

5. Are qualifications and training records maintained for all personnel?


Photo Comment

6. Are the qualifications and experience requirements for trainers defined in the training procedures?


Photo Comment

7. Training records must be maintained for all personnel and should include: Date, Topic, Name of Instructor, Employee Signatures, Tests, Quizzes, etc.


Photo Comment

8. Specific training requirements are defined for each unique job description or job function.


Photo Comment
Purchasing And Customer Service

1. Is there a system to notify customers of delivery days?


Photo Comment

2. How are they notified? E-mail, fax, phone, mail? Is this documented?


Photo Comment

3. What systems or processes are in place for Cost of Quality (i.e. scrap, reduction, rework, commodity planning)?


Photo Comment

4. An up-to-date organization chart with names/key personnel available.


Photo Comment
Customer Service

1. Is there evidence of a Customer Service System?


Photo Comment

2. Is there a process of getting the Company contact list?


Photo Comment

3. Is there a process for requesting samples or information?


Photo Comment
General

1. Are there contingency plans for serious problems (fire, tornado, flood, etc.)?


Photo Comment

2. Is there a system to identify facility, machine, and operational needs for the future?


Photo Comment

3. An established complaint investigation and response program exists