Good Manufacturing Practice

The Good Manufacturing Practice (GMP) principles put forward by the US Food and Drug
Administration help ensure quality of manufactured product throughout the manufacturing,
processing and packaging stages. They are used to create a quality framework for the
manufacture of a wide variety of products including drugs, medical devices, some food, and
blood to make sure that the products are safe, pure, and effective. GMP principles (often
designated ‘cGMP’ – current Good Manufacturing Practice) address a wide range of issues as
varied as record keeping, personnel qualifications, sanitation, cleanliness, equipment
verification, process validation, and complaint handling.

1. Defined operating procedures and work instructions to est ablish

controlled and consistent performance

Standard Operating Procedures (SOPs) and work instructions are stored maintained within
the integrated document management system.

2. Adherence to written procedures and instructions

SOPs and work instructions are available for users to reference directly. Relevant SOPs can
be presented based on the current user task, and visual workflows guide users through the
laboratory process. By defining access rights and managing competency records users are
only able to carry out tasks relevant to their function and which they have been trained to
carry out.

3. Prompt and accurate documentation of work for compliance and

traceability

As user’s complete workflow tasks or actions within, an Electronic Signature can be created
that records who completed the action and when. A reason for the action can also be recorded
if necessary. Data entered is recorded directly in the database at the time of entry. Analytical
results, and the ID of the instrument used, can be captured automatically removing the
possibility of transcription errors and a record of media and reagents used can be maintained.
If users can modify data within the system an audit trail can provide access to a complete
history of the changes made including who, when, why and the changes made.

4. Prove that the systems do what they should through validation

We should manage data and information that supports system validation. For example,
instrument calibration and sensitivity measurements and records can be managed through
LIMS and are easily accessible for validation purposes.
5. Properly defined and designed system and equipment

Validation and ensure facility, system and equipment suitability should be done. As an
example facilities must be designed to prevent contamination (microbial, particulate or cross
contamination). An Environmental Monitoring facility will allow the setup of Sampling
Points within a Sample Location, i.e. within a sterile filling facility the air vents, bench tops
and the filling machines themselves need to be monitored for contamination. The tests (and
associated limits) and testing frequencies required for each sampling can be defined. Results
are recorded and alerts triggered for out of specification results, previous results can also be
reviewed to identify possible trends.

6. Properly maintain facility and equipment

Instrument and equipment maintenance and calibration schedules should be supported.

Instruments and equipment can be flagged as unavailable if they are out of maintenance or
calibration and it is possible to prevent tests being assigned to specific instruments if they are
flagged as unavailable.

7. Define, develop and prove job competency

Competency and training records can be maintained and it is possible to prevent individuals
carrying out specific tasks if they do not have a valid training record.

8. Protect products from contamination

Ensure ongoing product quality and Environmental Monitoring functionality is specifically

designed to monitor possible contamination at specific location and sampling points on an
ongoing basis.

9. Build quality into products

Raw materials and finished products can be tested against Master Record specifications and
release mechanisms implemented for Batches and Lots. Defined workflows help ensure
adherence to quality processes and full traceability of actions carried out is supported.

10. Perform regular audits to ensure compliance

Audit process (internal and external) by providing access to required information from a
single integrated source should be supported. Training records, Instrument calibration and
maintenance records, the results of QA/QC testing and other relevant information can be
recorded in, and retrieved from, the LIMS data base together with required electronic
signatures and audit trail.
 HACCP

The HACCP approach HACCP is an approach to food safety that is systematic and
preventive. It is recommended by the Codex Alimentarius Commission, the United Nations
international standards organization for food safety. HACCP is used by most countries
around the world and has been in use since the 1960s. HACCP goes beyond inspecting
finished food products. It helps to find, correct, and prevent hazards throughout the
production process. These include physical, chemical, and biological hazards. There are
seven universally accepted HACCP principles. Every country that uses HACCP follows these
principles.
Principle 1: Hazard analysis
A plan is laid out to identify all possible food safety hazards that could cause a product to be
unsafe for consumption, and the measures that can be taken to control those hazards. For
example, at the cooking step of the production process, one of the identified hazards is the
survival of pathogens due to inadequate cooking time or temperature.

Principle 2: Identifying critical control points

Critical control points are the points in the production process where an action can be taken to
prevent, eliminate, or reduce a food safety hazard to an acceptable level. For example, the
cooking step is considered a critical control point because control measures are necessary to
deal with the hazard of pathogens surviving the cooking process.

Principle 3: Establishing critical limits for each critical control point

A critical limit is the limit at which a hazard is acceptable without compromising food safety.
For example, critical limits at the cooking stage include specific time and temperature for
cooking the product.

Principle 4: Establishing monitoring procedures for critical control points

Highly detailed monitoring activities are essential to make sure the process continues to
operate safely and within the critical limits at each critical control point. For example,
monitoring procedures at a cooking critical control point could include taking the internal
temperature of the product with a specialized thermometer.

Principle 5: Establishing corrective actions

Actions must be taken to bring the production process back on track if monitoring indicates
that deviation from critical limits has occurred. In food production, correcting problems
before end-stage production is far more effective than waiting until a product is finished to
test it. For example: If the required internal temperature has not been reached, a corrective
action would require that the product be cooked further. If the cooking temperature cannot be
reached, another corrective action would call for the product to be held and destroyed.
Principle 6: Establishing verification procedures.
Verification means applying methods, procedures, tests, sampling and other evaluations (in
addition to monitoring) to determine whether a control measure at a critical control point is or
has been operating as intended. Verification activities also ensure that the monitoring and the
corrective actions are done according to a company’s written HACCP program. For example,
testing and calibrating thermometers is a verification procedure that is important to ensure
accurate readings. The easiest way to test a thermometer’s accuracy is by submerging the
probe into a pot of boiling water. If it does not read 100˚C (212˚F) then the thermometer must
be adjusted to read the correct temperature.

Principle 7: Record keeping

The company must keep records to demonstrate the effective application of the critical
control points and assist with official verification (which is done in Canada by the Canadian
Food Inspection Agency). Records must be established to document the monitoring and
verification results as well as all information and actions taken in response to any deviations
found through monitoring and verification. For example, the employee responsible for
monitoring a cooking critical control point completes a cooking log sheet. This sheet includes
the date, the start and finish time, the temperature, and the employee’s signature. If a
deviation has occurred in the production process, the responsible employee records the details
in a deviation log book.
 Personal hygiene
Good personal hygiene habits include:
• washing the body often. If possible, everybody should have a shower or a bath every
day. However, there may be times when this is not possible, for example, when
people are out camping or there is a shortage of water
• If this happens, a swim or a wash all over the body with a wet sponge or cloth will do
• cleaning the teeth at least once a day. Brushing the teeth after each meal is the best
way of making sure that gum disease and tooth decay are avoided. It is very important
to clean teeth after breakfast and immediately before going to bed
• washing the hair with soap or shampoo at least once a week
• washing hands with soap after going to the toilet
• washing hands with soap before preparing and/or eating food. During normal daily
activities, such as working and playing, disease causing germs may get onto the hands
and under the nails. If the germs are not washed off before preparing food or eating,
they may get onto the food
• changing into clean clothes. Dirty clothes should be washed with laundry soap before
wearing them again
• hanging clothes in the sun to dry. The sun's rays will kill some disease-causing germs
and parasites
• turning away from other people and covering the nose and mouth with a tissue or the
hand when coughing or sneezing. If this is not done, droplets of liquid containing
germs from the nose and mouth will be spread in the air and other people can breathe
them in, or the droplets can get onto food

Overcrowding
When there are too many people in any house, the likelihood of them getting disease is
greater than if the house is not overcrowded. This is because people in an overcrowded house
will be much closer to each other and it is therefore easier for any germs to spread from one
to another. For example:
• sneezing and coughing in crowded rooms makes it easier to spread cold and flu germs
• sharing towels can spread trachoma germs and other germs which cause eye
infections (runny or sore eyes)
• several children sleeping in the same bed makes it easier to spread a scabies infection