GMP

GOOD MANUFACTURING PRACTICES

GOOD MANUFACTURING PRACTICES

ABOUT GMP

GMP is an abbreviation for Good Manufacturing Practices. GMP is an initiative of the WHO. The main aim of GMP is to see to it that the products are good enough for utilization after the final outcome. GMP governs the product at each and every step of manufacturing. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, and other countries. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous.

What is GMP

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products , dietary supplements, and medical devices . These 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 tenets 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 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).
GMP controls methodologies of manufacture, testing, design and control. The Manufacturers must employ technologies and systems, which are up-to-date. Systems and equipment used to prevent contamination, mix-ups, and errors are adequate by today’s standards.
We offer GMP Compliance Certification to Good Manufacturing Practices- GMP in Pharmaceutical, medical equipment, Food Industries and other relevant industries.
Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.

 

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Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.

Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.

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BENEFITS

GMP Compliance:

  • Guarantee that the food delivered to the customer fulfills all quality and safety requirements
  • Produce a certificate to the customer’s request
  • Offer better product quality through better control within its facility
  • Guarantee consistent quality conditions within a controlled process on its premises
  • Easily meet requirements and inspections from other standards, such as the FDA or HACCP.

 

REQUIREMENTS

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.

APPLICATION

Quality-assured, safe and effective medicines, vaccines and medical devices, including in-vitro diagnostics are fundamental to a functioning health system. But globalized trade can undermine regulation, and in resource-limited settings especially, incidence of substandard or falsified medicines is growing. WHO aids countries to strengthen regulation, including post-marketing surveillance, and to eliminate substandard and falsified medicines. It also develops international norms and standards, so that countries worldwide can regulate health products and technologies consistently.

BASIC PRINCIPLES OF GMP APPLICATION

Manufacturing facilities must maintain a clean and hygienic manufacturing area. 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 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 evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures. Records 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.

Frequently Asked Questions