As per [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK] Procedure- EVL/GMP/C-A/8556/C-2
Good manufacturing practices (GMP) are the approved and International practices required by Organizations in order to conform to the guidelines recommended, that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These requirements and guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.
Additional principles include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Guidelines developed by Euro Veritas (accreditated by BAR-UK) as per laid down Procedure / Scheme No EVL/GMP/C-A/8556/C-2 allows organizations to follow the few basic principles:
These Principles are for Organizations and cover the following:
• Manufacturing
• QA/QC
• Storage
• Logistics
• Packaging & Labelling
Organizations with Manufacturing facilities must maintain a clean and hygienic manufacturing area.
Organization with Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
Manufacturing processes must be clearly defined, documented and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes must be controlled, and any changes to the process must be documented and evaluated. Changes that affect the quality of the drug are validated as necessary.
Instructions and procedures must be documented in clear and unambiguous language using good documentation practices.
Operators must be trained to carry out and document procedures.
Records and evidences must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
• Any distribution of products must minimize any risk to their quality.
• A system must be in place for recalling any batch from sale or supply.
• Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
• Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the food or drugs minimizes any risk to their quality.
• A system is available for recalling any batch from sale or supply.
• Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
Good manufacturing practices are recommended with the goal of safeguarding the health and safety of consumers and users as well as producing quality products. In various countries, a food or drug may be deemed "adulterated" if it has passed all of the specifications tests but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline.
GMP guidelines are not prescriptive instructions from [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK] on how to manufacture products. They are a series of general principles, reviewed and generalized by [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK] as laid down in Procedure / Scheme No EVL/GMP/C-A/8556/C-2 that must be observed during manufacturing, storage, QA/QC and other Logistics and Packaging and Labelling. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs.
GMPs are also enforced by U.S. Food and Drug Administration (FDA), under Title 21 CFR. The regulations use the phrase "current good manufacturing practices" (CGMP) to describe these guidelines. Please contact us at [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK] for further details about this.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world.
GMP refers to the Good Manufacturing Practice regulations promulgated by the Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ current technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago may be less than adequate by current standards.
Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. In various countries, a food or drug may be deemed “adulterated” if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfil GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.
The key benefits to GMP certification from [Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK]:
• Prove organization’s management capabilities in product quality, safety assurance
• Enable employees to develop good production / operations habits
• Reduce safety risk in product quality and safety
• Timely detect production and management problems, reduce cost
• Better understand and comply with the relevant laws and regulations
• Enhance the international credibility and public image
• Increase customer’s long-term confidence in the enterprise
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.
What are CGMPs?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA and reviewed / approved vide Euro Veritas Procedure / Scheme No- EVL/GMP/C-A/8556/C-2. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. For example- Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards eg. Including ISO 9001:2015 and / or ISO 13485:2016.
