Food Service Management Technology - Importance of (GMP)

Good Manufacturing Practices (GMP)

  Good Manufacturing Practice (GMP) Resources
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made.

Each section of code outlines a different GMP activity. 211.22 details the responsibilities of a quality control unit, for example, while 211.25 discusses personnel qualifications, 211.28 deals with sanitation, clothing, protective apparel, hygiene and health habits and 211.34 offers guidelines on working with consultants. Part 1271 subparts C and D describes donor-eligibility and applicable current good tissue practice procedures for owners and operators of establishments engaged in the recovery, donor screening, donor testing and other types of testing, processing, storage, labeling, packaging, or distribution of human cells, tissue samples, and cellular and tissue-based products (HCT/Ps).
A. General ProvisionB. Organization and PersonnelC. Building and FacilitiesD. EquipmentE. Control of Components and Drug Product Containers and ClosuresF. Production and Process ControlsG. Packaging and Labeling ControlsH. Holding and DistributionI. Laboratory ControlsJ. Records and ReportsK. Returned and Salvaged Drug Product
Its 11 subparts discuss all sections of drug manufacturing operations:
Part 210.2 applies to drug products intended for human use and lays out definitions for terms used within the document. Part 211 describes important issues.
About Part 210 and 21121 CFR Part 210 and 211 outline the manufacture, processing, packing, or holding of a drug specifically, although supporting companies and services can benefit by compliance with these standards as well.
When discussing current good manufacturing practices, many agencies use the acronym cGMP, with the letter ‘c’ standing for ‘current.’ This nomenclature reminds companies to use the most up-to-date technologies and systems in order to comply with current regulations. Many older GMP practices, specifically those designed to prevent errors, mix-ups and contamination, are now outdated and inadequate.
About GMPGMP is a set of regulations that ensures the quality of drugs, medical devices, blood, and some types of food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product.
Trained inspectors for the FDA examine facilities around the world, including those facilities that produce the active ingredients and final products. The FDA also reviews consumer and industry complaints filed about the drug, using these reports to identify sites that could benefit from inspection.
In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.
The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.
MP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.Auditing for GMP is specifically designed to address the challenges of GMP auditing for the food or pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry. Audits can be split to Product, Process and Management System and be performed by Internal inspections or by regulated audits teams. As manufacturer you are responsible for the whole process and products, even for the used products which are produced by others. It is advisable that a manufacturer plans supplier audits the check the raw materials and their organization. The other parties must also be qualified and certified to get a reliable and reproducible product quality.
Why Audits?
Data history of validated manufacturing steps, used validated equipment, distribution, serialisation and Track & Trace support.
Processes must follow the Good Documentation Practices (GDP)
Operators must be qualified and trained
Processes must be controlled
Conditions in order to prevent cross contamination and protections to adulterants
Processes must be clearly defined and controlled
Manufacturing must be done in clean and hygienic areas.
To control this we must provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. This guidance has a few basic principles:
How do we control this in practice?
GMP is a set of regulations that ensures the quality of drugs, medical devices, blood, and food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product. The US Food & Drugs Association (FDA) is responsible for protecting and promoting public health through regulation and supervision during the whole process of developing, testing, manufacturing and promotion of food and drugs. FDA 21 CFR Part 111 effects the dietary supplement industry and deals with the manufacturing, processing and holding of these substances. FDA CFR Part 210 deals with the manufacturing, processing and holding of drugs, while CFR Part 211 deals with finished pharmaceuticals.
Can GMP regulate that Quality?
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.
Quality Assurance versus Quality Control
So, GMP must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
For the consumer the product needs to come with clear and understandable instructions which comply with Good Documentation Practices, deprived of ambiguous or confusing language.
Manufacturing processes need to be strictly defined and well controlled, ensuring that any product is made in accordance with predefined specifications. During this control, if any changes or alternations affect the product, it should be analyzed and checked for quality. Should the product lose quality due to these alterations, it should be discarded.
GMP stands for Good Manufacturing Practice and is a quality control system which makes sure that every pharmaceutical product is adequately tested and dosed for optimal effectiveness. GMP also controls the quality of food, diagnostics, ingredients in drugs and food, pharmaceutical products and devices used in medicine. Thus, GMP makes sure that a company follows a set of rules and regulations, producing something that meets all the necessary quality requirements.