Principles of GMP

10 Principle of Good Manufacturing Practises 

Good manufacturing practices is part of quality assurance which are particularly set of guidelines including basic control measure and procedures to be followed to meet standard specification of product which are safe to consume by human. These regulations address a variety of areas, including cleanliness, personnel qualifications and record-keeping, all in an attempt to ensure safety in the manufacture and care of FDA-regulated products by minimizing the chance of contamination or human error. To follow good manufacturing practices there are 10 basic principles which need to be addressed.

PRINCIPLE 1: Step by step written procedures

All operating procedures and work instructions should be written down and made available to employees for better understanding of the facility working procedures. Standard operating procedures are established methods that are to be followed routinely for the performance of the designated operations.

PRINCIPLE 2: Follow procedures

In the food industry it is critical that good procedures are in place to ensure a controlled and consistent performance. Written procedures are to be concise and logical so that it is easy to follow and understand. While following SOP or written procedure it is important to mark that no shortcuts should to be taken as they lead to deviation from the procedure which may lead to hazards.

PRINCIPLE 3 Document work

Prompt and accurate documentation of work provides official information or serves as a record helping in compliance and traceability. In case of error, these records can serve as the basis of investigation. E.g. Equipment user manual, GMP Manual

PRINCIPLE 4 Validate work

Establishing documentary evidence that the procedure, process or activity and production maintains the desired level of compliance at all stages. Maintaining and validating of consistent performance is very important. Correctly following written procedures are necessary.

PRINCIPLE 5 Integrate productivity, quality & safety into facilities & equipment

During construction of company facility and equipment it is important to integrate productivity, quality & employee safety. Designing and assigning location of equipment should suit its intended use. Segregation of materials, products and their components to minimize confusion and potential mix up and error This reinforces the goals of quality and consistency at all stages of the process. Product quality is impacted by factors like air, water, lightning and ventilation temperature.

PRINCIPLE 6 Maintain facilities & equipment

Proper maintenance of equipment and facility with valid documentation backing the details for maintenance minimizes any safety concern and avoid potential issues relating to contamination and quality control. Proper maintenance schedule prevent equipment breakdown, reduces risk of product contamination and maintain the validated state of the facility or equipment.

PRINCIPLE 7 Define, develop & demonstrate job competency

Each employee should be provided with training whose activities could affect product quality. Training should be inclusive of basic training on theory & practice of GMP as well as role related training. Employees should demonstrate job competence by producing quality products in a safe & efficient manner.

PRINCIPLE 8 Make cleanliness a daily habit

This principle outlines the importance of ensuring a product to be protected from contamination by practicing good hygiene. This can be achieved by incorporating cleanliness in the workplace on daily basis. All cleaning and sanitization procedure should be diligently followed. Apart from reporting conditions that may lead to contamination it is important to minimize human contact with product and equipment. Food contamination can either physical, chemical or microbiological in nature. Contamination can be of indirect form as well like unintentional transfer from one to another posing hazard like allergen.

PRINCIPLE 9 Build quality into the product

Every step in the products life cycle requires effective controls to ensure the quality of the product which can be achieved by controlling components, controlling the manufacturing process, packaging & labeling controls, holding and distribution controls.

Components can be kept in check by controlling ensuring all material and components are meeting the defined specifications. All components should be identified and stored in quarantine area for sampling & testing. For Controlling manufacturing process all product should have master record outlining specification with individual batch/history record. To enable traceability assigning batch no. to all products inspecting packaging & labeling before processing new batch are few of packaging and labelling control methods. And for holding and distributional control proper controls to be in place against contamination, mix ups and errors

PRINCIPLE 10 Conduct compliance & performance audits

Only way to determine how well GMP is being implemented is to conduct planned and periodic audits. Audits must be conducted to assess whether the facility is following GMP. Audits can be internally held to ensure GMP compliance by in house audits or external audits can be conducted by external bodies such as FDA etc.

1 Comment

  • Pavi

    Content is nice but
    you give points by points
    Topic name give short of side topic
    Niceeeeeeeee guide thanks for the GMP notes very usefull thankyou so much ❤️❤️😊😊😊😊😊

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