GxP are quality standards and regulations which are to be followed in specific fields. GxP is a concept of good practices where G stands for ‘Good’, x is an acronym which stands for particular field like ‘Manufacturing/Laboratory/Clinical, etc.’ and P stands for ‘Practices’.

GxP is a quality benchmark which is a complex practice and which can be aligned with other quality standards like the quality management system, ISO 9001:2015 or ISO 27001:2013. These quality standards are mainly to ensure that the entire process of the product manufacturing meets the prerequisite standards and the products being produced are safe and fit for use. These principles or practices when applied effectively leads to a state ‘where quality is built into the system’.

These guidelines are developed to protect the consumers. The guidelines are created and enforced by national or international regulatory agencies, like the United States Food and Drug Administration (FDA) or the global International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) or World Health Organization (WHO), to ensure that products, research, and projects are done safely and that the end products are safe to use.

The five elements of 5P’s are as follows:

five elements of 5P’s

Some of the GxP’s used in Pharmaceutical industries are:

GMP – Good Manufacturing Practices:

This is a concept which ensures that products are consistently manufactured and controlled according to quality standards. It sets out the best practices to ensure that the products are packed & labelled correctly and have the desired effect as they claim. It is designed to minimize the risk in production. GMP guidelines are concerned with all the aspects of the production like properly calibrated instruments, good condition facilities, competent employees, reliable process etc. GMP if followed correctly can reduce the risk of cross contamination and errors and can result in obtaining good quality products.

GDP – Good Distribution Practices:

GDP is related to the distribution practices. In order to supply, sell, import or export drug products an authorised dealer is required. It helps in the navigation of distributors in the supply chain. It is aimed to ensure the quality of the product throughout all the stages of supply chain. Distribution guidelines consists of purchase, storage, transportation, packing, repacking, labelling, documentation and keeping records.

GLP – Good Laboratory Practices:

GLP is devised to promote quality test data to protect the environment and human health and to allow reliable scientific data to be generated. These guidelines are for non-clinical laboratory tests and studies conducted to assess the safety and efficacy of products. Items contained in the guideline are related to medicines, pesticides, veterinary drugs, cosmetics, additives and industrial chemicals. This practices ensures that every test carried out in a laboratory, greenhouse, field or any facility must meet the standards in terms of equipment’s, procedures and personnel.

GCP – Good Clinical Practices:

GCP is an international standard for designing, conducting, recording and reporting the clinical trials involving human subjects. The clinical trial sites shall give assurance that the rights, safety and wellbeing of the subject are protected and are thus producing reliable data and results. A trial is carried out only when the benefits expected in the study outweighs the risk. The data generated should be handled and stored so that it can be easily verified and interpreted. All the records of the subjects are to be kept confidential.

 

GSP – Good Storage Practices:

These are practices required for storage and distribution of products to ensure that the nature and quality of the products remains as intended when it reaches the customer. It is also important to prevent sub-standard and falsified products to enter the supply chain which can pose as a real threat to public health and safety. It consists procedures for receiving, storage and distribution of materials/products. Various components of GSP are premises/warehouse, storage facilities, personnel, stock management and control and documentation. Uniform temperature and humidity shall be maintained at the storage location

GRP – Good Review Practices:

Good review practices (GRP) are documented best practices related to the process, format, content, and/or management of a product review. GRPs are developed over time to provide consistency to the overall review process of new products. GRPs improve efficiency, clarity, and transparency of the review process and review management. Developing GRPs is an attempt to identify, collect, enhance, implement, and adopt many of these best practices as documented and standardized GRPs that can be shared among other divisions. Fundamental aspects of GRP are to enhance the quality of review process, to improve the efficiency of the review process through standardization, provides clarity in the review process, leads to transparency and consistency by providing standards review.

Apart from the above mentioned GxP’s there are various other Good Practices namely Good Engineering Practices, Good Documentation Practices etc.

GxP guidelines are composed of the minimum requirements that should be followed by organizations in the business of production in order to ensure that the products meet the requirements and are safe for the consumers. These are a very important part of all the regulated industries.