Gmp Good Manufacturing Practice Audit Construction

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GMP (Good Manufacturing Practice) Audit - Construction

GMP (Good Manufacturing Practice) Audit - Construction

Design And Construction

Construction And Maintenance

Pest Control Program

Cleaning & Sanitation

Materials Management

Traceability

Storage

Temperature And Humidly

Process Quality Control Plan (Packaging / Raw Materials)

Incoming Quality Control

QC Micro Lab

QC Analytical Lab

Batch Records

Contamination

General Controls

Manufacturing Process Controls

Packaging And Identification Labelling

Label Issuance And Control

Packaging And Labelling Operations

Quality Management Systems

Effectiveness Of The Quality Management Systems

Internal Audits

Personnel And Training

Hygienic Practices

Training Procedures

Purchasing And Customer Service

Customer Service

General

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Gmp Good Manufacturing Practice Audit Construction

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

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

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

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

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

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

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

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

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

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

2. Seams are well bonded and smooth.

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

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

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.

1. A documented pest control program is in place.

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

3. Map with locations of all traps identified

4. The pest control program includes frequent inspections.

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

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

7. The facility audits pest control operator performance.

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

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

3. There are written operating procedures or work instructions.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Containers designed to protect against adulteration.

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

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

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).

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

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

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

4. Does QC have a product standard reference system?

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

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

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

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

3. Does QC have updated product specifications?

4. Are customer product standards available and used?

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

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

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

3. Does Micro QC have updated product specifications?

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

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

6. Does a documented calibration and maintenance program exist?

7. Does a validation program exist?

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

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

3. Does Analytical QC have updated product specifications?

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

5. Does a documented calibration and maintenance program exist?

6. Does a validation program exist?

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

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

9. Establish, validate and document test methods.

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

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

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

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

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

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

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

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

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