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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. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 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. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety programme are being followed.
Is GMP necessary if there is a quality control laboratory?
Yes. 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
Costing of GMP: Can manufacturers afford to implement GMP?
Yes. 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.
GMP certification is a very important and essential certification for all the companies that are engaged in the manufacturing of the food as well as Pharmaceutical products. The GMP certification helps the manufacturers in adopting the best manufacturing practices that ensnare the best quality of products delivered to the consumers. This is not only helpful in decreasing the quality flaws in the products but the certification provides a set of guidelines that helps the manufacturers in ensuring the best handling and management of each and every aspect of the manufacturing process such as handling of raw materials, commencing the manufacturing process, handling of the products, distribution of the products and so forth.
With the help of GMP certification, the companies can ensure that the products delivering to the consumers are manufactured under the best supervision and the best quality of the materials and ingredients is used with right potency which gives the best benefits to the company. In addition to ensuring the best quality of the products, GMP certification also helps in minimizing the losses of the company by ensuring the least amount of rejection of products due to quality flaws. It also ensures the least wastage of the raw materials due to the presence of an efficient system for efficient handling of the products as well as raw materials.