GMP Certification in Pune (2 service providers available)

We, being a distinguished name in the market, indulge ourselves in offering GMP Certification services. We meet the customized requirements of the clients being a devoted Service Provider. Our dependable services are applauded worldwide by our clients. Get in touch to avail it in an efficient and effective manner. Thanks to our specialized ISO implementation methodology, the whole process becomes less time consuming, easy to understand and implement, result oriented, time bound and cost effective. The services on offer are available for a reasonable fee.What is GMP Certification? Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. 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 fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process. Principles of GMP Standards : 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 language. (Good Documentation Practices) 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 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 drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. Contact us now, to get your organization GMP certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized implementation methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective.

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 practices? Many countries have formulated their own requirements for GMP based on WHO GMP.