Maintain quality with a GMP compliance audit template

1- Buildings and Facilities

1.1 Design and Construction

The grounds of the facility are well maintained, including roads, parking lots, grass and drainage areas.

REFERENCE: The production facilities both inside and outside are clean. [This is an example of how you can use Lumiform to include practice reference images in your templates to aid inspection].

Adequate environmental controls exist and are kept up to date (controlled lighting, humidity, temperature, air filtering etc...)

There is sufficient space provided for the orderly storage of equipment and materials to avoid mix-ups and possible contamination.

All surfaces in contact with food consist of materials suitable for the treatment (i.e. stainless steel vs. aluminium)

All water systems are appropriately preserved against backflow.

There are enough hand-washing facilities for restrooms, break rooms and production areas.

Windows, walls, floors and ceilings are completely sealed to prevent entry of diseases, insects or any other concerns.

Loading dock doors are flush to the ground when closed.

In order to prevent contaminations, defined areas are seperated and there are enough controls.

1.2 Construction and Maintenance

Seams are well bonded and steady.

For the majority of the equipment a preventive maintenance program was developed and implemented.

Non-toxic and corrosion resisting materials like stainless steel are used throughout the whole process.

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

Measuring, weighing, testing and controlling equipment, which is crucial for ensuring quality, should be callibrated using certified or traceable standards and should be done according to written methods, defined schedules.

1.3 Pest control program

A documented pest control program exists.

The exterior of the building is protected against the penetration of rodents and pests.

A map with locations of traps exists.

The pest control program includes regular inspections.

The supplier maintains and enforces documented procedures for the use of pesticides.

All chemicals used in pest control are accurately marked and safely storaged.

The institution checks the performance of the pest control personnel.

1.4 Cleaning & Sanitation

There is a written and extensive plant and a program for the hygiene of the equipment.

The maintenance of the plant and devices guarantees a safe production of healthy food.

There are written working procedures or work directions.

Brushes and other tools used for cleaning surfaces in contact with food are inspected and clearly marked.

There are measures to inspect and monitor the efficiency of the cleaning procedures.

The cleaning and sanitization procedures are well-documented as such and validated.

Cleaning and usage protocols for main units contain the following information: products, dates, sections, the person who used them and also the person who cleaned them.

Food containers, e.g. tanks or hoppers, must be adequately covered.

A chemical control program exists. It manages the storage, use and handling of non-food chemicals at the production department.

2 - Materials Management

2.1 General Controls

There are written procedures that describe the identification, quarantine, storage, handling, receipt, sampling, testing and approval or rejection of the equipment.

There is a system to control the GMO and non-GMO allergens.

There are appropriate environmental controls, and they are maintained (lighting, controlled temperature, air filtration, etc...).

Producers of intermediates and/or APIs have a system for assessing suppliers of critical materials.

The materials are purchased against an arranged specification from suppliers approved by the quality unit(s)).

2.2 Traceability

Batch traceability system with a distinctive batch number for all raw products, in-process materials, finished goods and packaging components exist.

First-in/first-out (FIFO) procedures for all materials and goods are defined and documented.

2.3 Storage

Equipment and materials should be handled/stored so that degradation, contamination and cross-contamination can be avoided.

Temperature and air humidity are permissible.

There are containers/storages for protection against adulteration.

Rejected materials are stored in seperated facilities so that usage is prevented.

The storage area is clean and neat and the 18-inch perimeter is maintained.

If necessary, materials should be reassessed to ensure their suitability for use (e.g. after long-term storage or in case of exposure to heat or moisture).

3 - Quality Control Systems

3.1 Process Quality Control Plan (Packaging / Raw Materials)

There is an established system showing inspection frequency, number of samples and necessary tests.

There are methods for out of specification (OOS) results to show how information is related to manufacture or how the product is used.

To ensure that you have the most up-to-date customer specification and you use and follow it, the systems are in place.

Do the Quality Control Systems have a product standard reference system?

Are there sufficient resources (test equipment, qualified staff etc.) to appropriately perform this function?

Are products (finished products as well as raw material or packaging) kept for one year after the minimum storage life?

3.2 Incoming Quality Control

There is an established plan that contains the frequency of inspections, number of samples and tests needed.

There is a procedure to deal with OOS results.

Does QC have up-to-date product specifications?

Do customer product standards existed and also used?

Are there sufficient resources (test equipment, qualified staff etc.) to appropriately perform this function?

3.3 QC Micro Lab

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

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

Does Micro QC have updated product specifications?

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

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

Does a documented calibration and maintenance program exist?

Does a validation program exist?

3.4 QC Analytical Lab

There is an established system showing inspection frequency, number of samples and necessary tests.

There is a procedure to deal with OOS results.

Does the QC Analytical Lab have up-to-date product specifications?

Are there sufficient resources (test equipment, qualified staff etc.) to appropriately perform this function?

Is there a documented calibration and maintenance program in place?

Is there a validation program in place?

Is there a process exist to sustain lab standards?

Is there a procedure to control and document lab reactants?

Define, validate and document test procedures.

4 - Manufacturing

4.1 Batch Records

All documents regarding the production of intermediates or Active Pharmaceutical Ingredients (APIs) should be prepared, checked, authorised and distributed according to a written SOP. The batch records...

... contain a list of raw materials, names, identification, characteristics, batch number(s) and weights.

... contain both, actual and theoretical weights/measurements and also the minimum and maximum percentages. (values beyond tolerable limits must be investigated)

... contain detailed production instructions and process control set points to ensure clarity, quality and consistent formulation.

... contain the documentation of every significant step in the production process.

... contain special comments on the examination/deviation from the prescribed procedure.

... are checked and approved by Quality Assurance (QA) for each seperate batch run.

... are stored for at least 1 year after the expiration date of the batch.

4.2 Contamination

Any material or utensils found to be infested with insects must be quarantined and promptly taken from the facilities.

Effective measures prevent the facilities and equipment from metal and foreign materials.

4.3 General Controls

The use of all containers, processing lines and main equipment during production was identified and recorded.

Carry out filling, assembling, packaging and other operations in a way that does not adulterate the products.

The methods for defining and monitoring critical process control points were documented.

4.4 Manufacturing Process Controls

There is an established plan showing inspection frequency, number of samples and necessary tests.

There is a procedure for OOS results. How is the product(s) used/handled?

Are the product standards used routinely?

Is production designed to meet customer specifications and demands?

Are there sufficient resources (test equipment, qualified staff etc.) to appropriately perform this function?

5 - Packaging and Identification Labeling

5.1 General Controls

Methods to receive, store, handle, sample, test and match packaging materials have been defined and are followed.

Create and follow a process to make sure that correct labels, markings and packaging materials are provided and used.

5.2 Label Issuance and Control

Only authorized personnel should have access to the label storage.

To determine the quantities of labels issued, used and returned, procedures have been developed.

Methods should be defined to determine how to inspect/evaluate differences between the amount of labelled containers and the amount of labels issued.

Methods for the destruction of obsolete labels should be developed and defined.

Printed labels produced for a batch should be carefully checked for correct identity and compliance with the specifications in the production record.

The batch record should include a printed label that is representative of the products used

5.3 Packaging and Labeling Operations

Ensure appropriate segregation of the various packaging/labelling operations carried out concurrently in the same area.

Label packaging and ingredients with a batch number so that the history can be determined and the batch can be checked.

Inspect packaged and labelled products to make sure they have the right label and batch number

Make sure that the correct procedures for releasing lines are in place and used during changeovers.

6 - Quality Management Systems

6.1 Quality Goals

There is an organizational chart that shows the actual reporting structure and responsibilities.

Does the organisation have an implemented and sustained quality management unit?

There is personell representative for the management, who has defined authority and responsibility for compliance with customer demands.

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

There is a quality guide provided that describes the quality system of policies and procedures in detail.

Define quality management procedures (Who is in charge of acting? What has to be done? When are measures necessary?)

The responsibility for updating and revising the quality guide and system is clearly defined.

The quality objectives of the company have been well documented, signed by an authorized representative and dated.

Quality objectives are understood and kept throughout the company.

Written procedures concern the following kinds of planning:

• Development of requirements

• Quality information systems

• Acceptance of procedures

• Verification of requirements

• Customer satisfaction

• Changing control

Permanent quality improvements are among the goals of the plant manager.

For the evaluation and planning, quality costs have been used.

Advance quality planning activities are reviewed with customers. There is documented proof.

6.2 Effectiveness of the Quality Management Systems

Lead times are measured and monitored.

The total cost of quality is monitored.

Cycle times are measured and monitored.

The management sets quality improvement goals every year.

The top management review the goals regularly.

A system exists to check whether the goals have been achieved and quality guidelines are adhered to.

The achievement of quality goals has high priority in the review of overall performance.

The quality guide is regularly reviewed, edited and communicated to the entire organisation.

There is a written and objective process for evaluating and tracking customer satisfaction.

6.3 Internal Audits

A documented procedure is in place to carry out internal quality checks.

Internal inspections are carried out every six months or according to a schedule based on the current status and importance of the activity.

The audit covers the working environment and general financial management.

The results of that inspection are well-documented and reported to the management.

There is an implemented and documented investigation and response programme for customer complaints.

Document revision and reprocessing procedures have been set up and reported.

Corrective actions are immediately implemented, recorded and assessed for their effectiveness.

7 - Personnel and Training

7.1 Qualifications and Experience

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

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

There are enough qualified personnel performing functions in manufacturing, packaging and QA.

7.2 Hygienic Practices

Are there hygiene procedures to prevent food contamination?

Staff must wear clean clothing suitable for the production activity. If necessary, additional protective clothing such as hand, arm, face and head coverings should also be worn.

Any person who has or appears to have an illness or open injury must be excluded from every task that contains contact with food or with surfaces that are in contact with food. This remains until the condition cured.

Staff is ordered to report such conditions to their supervisors immediately.

There are special areas provided for clothing and other personal items (jackets, wallets, mobile phones, bags etc.)

consuming food or drinking, chewing gum or smoking is strictly prohibited in the processing areas.

Signs in break rooms, production areas and washrooms remind people of the correct way to wash their hands.

There are written procedures that include and address the control and proper monitoring of the above practices.

7.3 Training Procedures

Have procedures been established and implemented to identify training needs? Training procedures must exist for all levels, including management, part-time and full-time staff, contract/construction staff, consultants and government and client inspectors.

The procedures relate to training plans, including recruitment, future training requirements or even succession and/or retraining frequencies.

The success of the training is regularly assessed.

Staff trainings cover general topics as for example hygiene, safety, environment, cGMP, SOPs & MSDS. Furthermore, training is offered on specific work instructions, equipment operations, procedures or, if necessary, to perform a specific work function.

Are qualification and training files/records kept for all personnel?

Are the requirements for the competence and skills for trainers defined in the training procedures?

Training records must be kept for all staff and should include the following: name of the instructor, subject, date, signature of staff, tests, etc.

For each job description or function, there are specific training demands defined.

8 - Purchasing and Customer Service

8.1 Purchasing

Is there a system for informing customers about delivery days?

How are they informed (e-mail, fax, telephone, post, etc.)? Is this formalised?

Which systems or processes exist for quality costs (scrap, reduction, rework, merchandise planning)?

An updated organization chart including names/key personnel is provided.

8.2 Customer Service

Do you have a Customer Service System?

Is there a Company contact list.

Is there a method for requesting examples or information?

8.3 General

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

Is there a method to identify buildings, machine, and operational requirements for the future?

There is a developed complaint investigation and response program.

Do you have a recall system?

Do you do mock recalls? On what regularity? Have you performed one recently? What were the results?

Do you have a documented security program?

Completion

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Comply with standards using a GMP compliance audit template

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